Semaglutide trials recruiting now

Who the trial lists, as registered

Lists people 18 and older. Conditions: Obesity; Type 2 Diabetes.

• Male or female (sex assigned at birth, inclusive of all gender identities).
• Age 18 years or above at the time of signing the informed consent.
• BMI≥ 35.0 kg/m\^2.
• Participants without T2D: No history of T2D and HbA1c < 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c < 10% (< 86 mmol/mol).

The exclusion criteria are on the listing.

What it tests, as registered

Cagrisema; Semaglutide

Registered summary

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Where, as registered

99 US sites in 30 states; also Canada (21), Argentina (15), Poland (15), South Africa (15), Bulgaria (14), Hungary (14), Greece (13), Spain (13), Romania (11), Czechia (9), France (9), Italy (9), Austria (8), Netherlands (8), Portugal (8), Slovakia (8), Australia (7), Belgium (7).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Type 2 Diabetes Mellitus.

• Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
• T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s)
• HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
• Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Elecoglipron; Semaglutide

Registered summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).

Where, as registered

64 US sites in 30 states; also Germany (19), Japan (16), China (15), United Kingdom (12), Canada (10), South Korea (10), Taiwan (10), Australia (9), Italy (9), Hungary (8), Poland (8), Argentina (7), Brazil (7), Bulgaria (5).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Overweight; Obesity.

• Male or female (sex at birth).
• Age 18 years or above at the time of signing the informed consent.

The exclusion criteria are on the listing.

What it tests, as registered

Zenagamtide; Semaglutide; Placebo (matched to semaglutide); Placebo (matched to zenagamtide)

Registered summary

The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.

Where, as registered

45 US sites in 16 states.

Who the trial lists, as registered

Lists people 8 to 18. Conditions: Overweight; Obesity.

• Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study related activities.
• The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
• The child must sign and date the Child Assent Form or provide oral assent (according to local requirements).
• Male or female.

27 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Cagrilintide; Semaglutide; Placebo cagrilintide; Placebo semaglutide

Registered summary

This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. The full summary is on the listing.

Where, as registered

34 US sites in 19 states; also China (9), India (9), Bulgaria (4), Israel (4), Italy (4), Poland (4), Romania (4), Slovakia (4), Taiwan (4), Australia (3), Croatia (3), Hungary (3), Malaysia (3), Mexico (3), Portugal (3), Serbia (3), Spain (3), United Kingdom (3), Austria (2), Belgium (2), Colombia (2), Denmark (2), Netherlands (2), Sweden (2), Thailand (2).

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Diabetes Mellitus, Type 2.

• Male or female (sex assigned at birth, inclusive of all gender identities).
• Age 18-75 years (both inclusive) at the time of signing the informed consent.
• Diagnosed with type 2 diabetes greater than or equal to (≥) 180 days before screening.
• Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without sodium-glucose cotransporter-2…

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

UBT251; UBT251 Placebo; Semaglutide; Semaglutide Placebo

Registered summary

The study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes. Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. Which treatment participants get is decided by chance. UBT251 is the treatment being tested and is not yet available for doctors to prescribe, while semaglutide is a medicine used to treat type 2 diabetes that doctors can already prescribe.

Where, as registered

25 US sites in 14 states; also Germany (8), Australia (6), Poland (6), Romania (6), Spain (6), Hungary (5), Slovakia (4), South Korea (4).

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Diabetes Mellitus, Type 2.

• Male or female (sex at birth).
• Age 18-75 years (both inclusive) at the time of signing the informed consent.
• Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as assessed by central laboratory at screening.
• Willingness to obtain a high weight loss (greater than \[>\] 25% of weight at baseline).

The exclusion criteria are on the listing.

What it tests, as registered

NNC0662-0419; Semaglutide; Placebo

Registered summary

This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The full summary is on the listing.

Where, as registered

23 US sites in 11 states; also Spain (6), Japan (5), Poland (5), Thailand (5), Croatia (4), Portugal (4), Slovakia (4), South Korea (4), Hungary (3).

Who the trial lists, as registered

Lists people 10 to 18. Conditions: Diabetes Mellitus, Type 2.

• Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities.
• The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
• The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
• Male or female.

18 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

CagriSema (Cagrilintide B and Semaglutide I); Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Registered summary

The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.

Where, as registered

21 US sites in 14 states; also India (9), Brazil (6), Argentina (5), Israel (5), Mexico (5), Colombia (2), Malaysia (2), Thailand (2), Taiwan (1).

Who the trial lists, as registered

Lists people 18 to 80; healthy volunteers accepted. Conditions: Alcohol Use Disorder.

• Veteran
• World Health Organization's (WHO) risk drinking level of Very High or High in the 28 days prior to screening (based on screening TLFB)
• Current diagnosis of moderate or severe alcohol use disorder (AUD), i.e., meeting at least 4 of 11 DSM-5 AUD criteria, based on semi-structured diagnostic exam, the Mini-International Neuropsychiatric Interview (MINI)
• Able and willing to provide informed consent

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide; Placebo

Registered summary

This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 24-week period, followed by a 4-week post-treatment safety assessment period. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 milligrams (mg) per week, depending on their tolerance. The full summary is on the listing.

Where, as registered

19 US sites in 14 states.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Chronic Kidney Disease.

• Female of non-childbearing potential, or male.
• For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
• Age 18 years or above at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening, or not diagnosed with type 2 diabetes mellitus.

5 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

NNC0519-0130; Placebo; Semaglutide

Registered summary

The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.

Where, as registered

18 US sites in 11 states; also Japan (19), Poland (19), Turkey (Türkiye) (14), Spain (13), Malaysia (10), Bulgaria (9), Czechia (8), Italy (8), India (7), Brazil (6), South Korea (6), Argentina (5), Australia (5).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Obesity; Overweight and/or Obesity; Overweight; Treatment Of Obesity.

• Aged ≥18 years.
• Currently taking semaglutide or tirzepatide for obesity management.

The exclusion criteria are on the listing.

What it tests, as registered

Semaglutide; Berobenatide; Tirzepatide

Registered summary

The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes. Participants will be in the study for about 11 months.

Where, as registered

16 US sites in 11 states.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Overweight; Obesity.

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Female or male (sex at birth).
• Age 18 years or above at the time of signing the informed consent.
• Body mass index (BMI) of

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide; Placebo

Registered summary

The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Results from this study will help select the most optimal lower dose of oral semaglutide that can be used for treating participants living with overweight or obesity.

Where, as registered

16 US sites in 12 states; also Poland (9), Spain (8), Bulgaria (6), Belgium (5), Greece (5), France (4), Denmark (3), Netherlands (3), Sweden (3).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Overweight; Obesity.

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Male or female (sex assigned at birth, inclusive of all gender identities).
• Age 18 years or above at the time of signing the informed consent.
• Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per square meter (kg/m\^2), or BMI >= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia,…

The exclusion criteria are on the listing.

What it tests, as registered

Cagrilintide; Placebo cagrilintide; Placebo semaglutide

Registered summary

The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.

Where, as registered

11 US sites in 8 states; also Greece (6), Portugal (6), Serbia (5), Hungary (4), Sweden (4).

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Opioid Use Disorder; Opioid Abuse and Addiction; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorder; Opioid.

• Age 18 to 75 years.
• Body mass index (BMI) > 18.
• Able and willing to provide informed consent prior to any study-related activities.
• Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis.

7 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide Pen Injector; Placebo

Registered summary

The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is: • Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids? The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids. The full summary is on the listing.

Where, as registered

4 US sites in 4 states.

Who the trial lists, as registered

Lists female participants 45 to 55; healthy volunteers accepted. Conditions: Menopause; Menopause Hot Flashes; Menopause Related Conditions; Cardiovascular.

• aged 45-55
• In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea18
• No current use of hormone therapy or hormonal contraception
• Presence of a uterus and at least one ovary in order to track menstrual patterns

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Metformin; semaglutide; Anti-hypertensives; Lipid Lowering Medication; Life style intervention; Fezolinetant; Hormonal therapy

Registered summary

What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.

Where, as registered

3 US sites in 3 states.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Diabetic Kidney Disease; Type 1 Diabetes.

• Adults (≥18 years) with type 1 diabetes
• Diabetes duration of ≥5 years
• Persistent urine albumin-to-creatinine ratio (UACR) ≥ 30 mg/g, on the most recent two measurements within the prior 3 years
• Estimated glomerular filtration rate ≥ 20 mL/min/1.73m2

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide; Placebo

Registered summary

The primary objective of this study is to determine the effects of semaglutide on change in albuminuria from baseline to 26 weeks in type 1 diabetes. The secondary objective is to determine the effects of semaglutide on change in kidney parameters (including kidney oxygenation and function) measured by MRI from baseline to 26 weeks in type 1 diabetes. Other objectives are to determine the glycemic effects and safety of semaglutide in type 1 diabetes.

Where, as registered

3 US sites in 2 states; also Canada (1).

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Overweight or Obesity; Atrial Fibrillation.

• Age 18-75 years
• BMI greater than or equal to 30 kg/m2
• Paroxysmal AF or persistent AF, in whom catheter ablation (CA) for AF is expected within 1 year (A group) or in whom catheter ablation is NOT expected within 1 year (M group)
• Ability to provide informed consent before any trial-related activities.

8 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide; Placebo

Registered summary

The goal of the study is to learn how a weight loss medication called semaglutide, which is used to treat obesity, in addition to standard AF treatment might affect AF, atrial fibrillation severity, and whether it changes the risk of atrial fibrillation recurring after standard AF treatments.

Where, as registered

2 US sites in 2 states.

Who the trial lists, as registered

Lists people 18 to 75; healthy volunteers accepted. Conditions: Obesity; Overweight; Cigarette Smoking.

• Ability to provide informed consent before any study-related activity, willing to comply with al study procedures, and be available for the duration of the study.
• Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension (unless meets medical exclusion criterion 7), cardiovascular disease (unless…
• Have been smoking ≥5 cigarettes per day for at least 1 year (prior to screening) and provide positive cotinine test.
• Desire to quit smoking (defined as "intend to quit within one month")

4 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

semaglutide 2.4mg; Placebo; Nicotine Replacement Therapy (NRT, nicotine patch); Brief Smoking Cessation Counseling

Registered summary

This trial will examine the effect of semaglutide 2.4mg on changes in body weight, body composition, and peripheral and central mechanisms that control appetite, satiety, and food intake in the context of smoking cessation.

Where, as registered

2 US sites in 1 state.

Who the trial lists, as registered

Lists people 20 and older. Conditions: Chronic Kidney Diseases; Obesity.

• Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Glomerular Filtration Rate (eGFR) 20 to <60 mL/min/1.73m\^2
• Able to perform resistance training
• Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network), desktop or laptop

The exclusion criteria are on the listing.

What it tests, as registered

SLIMM; Standard Resistance Training; Guided Resistance Training; Placebo; Semaglutide

Registered summary

* Prolonged sitting (sedentary behavior) is a risk factor for decreased kidney function, obesity, diabetes and mortality. Prolonged sitting is associated with decreased kidney function and increased risk of diabetes, heart disease and death. * In a previous pilot study funded by NIH, it was shown that a Sit Less, Interact and Move More (SLIMM) intervention targeting sedentary behavior in people with kidney disease was able to decrease prolonged sitting but that effect was not sustained. The full summary is on the listing.

Where, as registered

2 US sites in 2 states.

Who the trial lists, as registered

Lists people 18 to 55; healthy volunteers accepted. Conditions: Overweight; Obesity.

• Male or female (sex at birth).
• Age 18-55 years (both inclusive) at the time of signing informed consent.
• Body Mass Index (BMI) 27.0-34.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening, with overweight due to excess adipose tissue as judged by the investigator.
• Considered eligible based on medical history, physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening, as judged by the investigator.

The exclusion criteria are on the listing.

What it tests, as registered

NNC0721-8060; Semaglutide; Placebo

Registered summary

The purpose of the study is to find out if NNC0721-8060 is safe and how it works in people living with overweight or obesity.

Where, as registered

2 US sites in 2 states.

Who the trial lists, as registered

Lists people 18 to 49. Conditions: Diabetes Mellitus, Type 1.

• Age 18-49 years
• 1\) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis
• Insulin pump or automated insulin delivery systems
• Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide Pen Injector; Placebo

Registered summary

This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. These procedures are considered to be experimental.

Where, as registered

2 US sites in 2 states.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Overweight; Obesity; Type 2 Diabetes.

• Male or female (sex assigned at birth, inclusive of all gender identities).
• Age 18 years or older at the time of signing the informed consent.
• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
• Participants on a stable treatment dose of (subcutaneous) s.c. semaglutide for at least 4 weeks.

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide; Zenagamtide

Registered summary

The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of semaglutide in people with overweight or obesity, with or without type 2 diabetes (T2D). All participants will get semaglutide and zenagamtide.

Where, as registered

2 US sites in 2 states.

Who the trial lists, as registered

Lists people 18 to 70. Conditions: Spinal Cord Injuries; Type 2 Diabetes.

• Male and female subjects aged 18-70 years (inclusive) at screening
• More than one year after spinal cord injury
• Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D.
• Provision of signed and dated written informed consent prior to any study specific procedures

5 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide Injectable Product; Placebo

Registered summary

It is not known whether a new diabetes drug, semaglutide, is an effective treatment for type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk for this condition. Therefore, this study looks at the effect of semaglutide on glucose levels in the body and other information about type 2 diabetes and obesity.

Where, as registered

2 US sites in 1 state.

Who the trial lists, as registered

Lists people 18 to 89; healthy volunteers accepted. Conditions: Obesity; Diabetes Type 2.

• BMI greater than or equal to 27 kg/m2
• Of Amish Descent

The exclusion criteria are on the listing.

What it tests, as registered

Semaglutide Pen Injector [Ozempic]

Registered summary

Overweight/obese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA. Lancaster County, PA. Pharmacodynamic responses to GLP1R agonist will be assessed by conducting frequently sampled intravenous glucose tolerance tests (FSIGT) both before and after semaglutide for six weeks. The proposal proposes two specific aims: 1. Specific Aim #1. To identify genetic variants associated with effects of a GLP1R agonist to enhance glucose-stimulated first phase insulin secretion in the two FSIGTs (before and after administration of drug). 2. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older. Conditions: PreDiabetes.

• Men and women, ages 18 years and older
• Diagnosis of Prediabetes - defined as either impaired fasting glucose (fasting glucose of 100-125 mg/dL), impaired glucose tolerance (2-hour postprandial blood glucose of 140-199 mg/dL after 75-gram oral glucose challenge), and/or a…
• High risk for progression to diabetes: defined as having at least one of the two following additional factors: Obesity (BMI ≥ 30 kg/m2) and/or metabolically unhealthy status.
• Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, hormonal contraception, intrauterine contraception, or surgical sterilization) for the duration of the study.

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide

Registered summary

This project uses both transcriptomic- and genomic-level data to identify mechanisms of individual responses to glucagon-like peptide-1 (GLP-1) in Mexican-Americans with prediabetes. The GLP-1 hormone is essential for glucose reduction, weight loss, cardiovascular risk reduction, and renal protection. Newly discovered mechanisms will illuminate causal links between disease genotype and phenotype, which may ultimately guide personalized therapeutic approaches for type 2 diabetes, prediabetes, obesity, cardiovascular disease, renal disease, and other related diseases.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 89. Conditions: HIV; Alcohol; Smoking Cigarette; Cardiovascular Disease Prevention.

• Ages 18-89
• Prior diagnosis of HIV-1
• Affiliated with Vanderbilt Comprehensive Care Clinic
• On current ART regimen for at least 90 days prior to study entry with no missed doses for at least 7 consecutive days.

6 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide (Rybelsus®); Placebo

Registered summary

The goal of this clinical trial is to learn if the drug semaglutide works to reduce alcohol intake among adults living with HIV. The main questions it aims to answer are: 1. Does semaglutide lower the average number of alcoholic beverages participants drink per week? 2. Does semaglutide lower the average number of cigarettes participants smoke per day? 3. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 65; healthy volunteers accepted. Conditions: Methamphetamine-dependence.

• Ability to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study,
• Age 18 - 65 years inclusive,
• Moderate to severe Methamphetamine Use Disorder by Structured Clinical Interview for DSM Disorders (SCID),
• Self-reported methamphetamine use ≥15 days out of the past 30,

6 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide; Placebo

Registered summary

GEM is a two-phase study to evaluate the use of semaglutide (Wegovy) for the treatment of methamphetamine use disorder (MeUD). The first phase is a pilot study, which will be an open-label, single-arm pilot study of 25 participants. Participants will receive Wegovy over a 12-week treatment period, with a subsequent follow-up visit at week 20. This phase will evaluate the feasibility, acceptability, and preliminary efficacy of Wegovy for MeUD. The second phase will be a phase IIb randomized-controlled trial to determine the efficacy of Wegovy in treating MeUD. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 12 to 18. Conditions: Pediatric Obesity; Metabolic and Bariatric Surgery; Semaglutide.

• ages 12 to 18 years
• Tanner stage 3 or higher
• severe obesity (defined as a BMI greater than 35 kg/m2 or BMI ≥140% of the 95th percentile)
• currently undergoing primary surgical weight loss through the pediatric bariatric surgery pathway at Children's Hospital Los Angeles

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide 2.4 mg

Registered summary

This is a Phase 3a, randomized, parallel-controlled trial designed to compare the early re-initiation of semaglutide, starting two weeks after sleeve gastrectomy, to standard care (no pharmacotherapy following surgery). The trial will involve 150 youth with severe obesity who have been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery. Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 65; healthy volunteers accepted. Conditions: Genetic Predisposition; Metabolic Diseases; Type 2 Diabetes.

• Males or non-pregnant females
• Ages 18-65 (inclusive)
• Able/willing to give consent
• Span the metabolic range between normal glycemia and pre-diabetes (fasting glucose of 100-125 mg/dL based on chart review of existing laboratory data)

The exclusion criteria are on the listing.

What it tests, as registered

oral semaglutide; Mixed Meal Tolerance Test (MMTT)

Registered summary

The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 100; healthy volunteers accepted. Conditions: Non-Alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease.

• Male or female Aged >= 18 years of age.
• Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP >= 285 db/M25) within 12 months.
• Estimated average alcohol consumption < 30 g/d for men or < 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior.
• Ability of subject to understand and the willingness to sign a written informed consent document.

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide

Registered summary

Background: In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help. Objective: To find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide. Eligibility: People with NAFLD and healthy volunteers ages 18 and older Design: Participants will be screened with: Medical history Physical exam Blood tests Imaging: A machine will take pictures of the participant s body. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists female participants 18 to 45; healthy volunteers accepted. Conditions: Pre Diabetes; Postpartum Disorder.

• Female
• 18 - 45 years old (inclusive)
• History of gestational diabetes in most recent pregnancy
• 6 months - 10 years postpartum

8 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide Pen Injector [Ozempic]; Placebo semaglutide pen injector

Registered summary

The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and reduce future risk of T2DM in young women.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 65. Conditions: Bipolar I Disorder; Bipolar II Disorder; Schizo Affective Disorder; Obesity; Weight Loss; GLP - 1.

• Men or women between 18 to 65 years old.
• Patients with a SCID IV confirmed diagnosis of bipolar disorder (BDI or BDII) or schizoaffective bipolar type (SZA-BD).
• Women with a negative pregnancy test 48 hours before study entry (obesity phenotyping visit).
• Patients with a negative urine drug screen except for allowable drugs.

4 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Group Therapy Program; semaglutide; Phentermine-Topiramate; naltrexone and bupropion (combination)

Registered summary

The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists female participants 12 to 35. Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Obese.

• Female
• Ages 12-35 years
• Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.
• Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines

7 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide Injectable Product (Wegovy and/or Ozempic)

Registered summary

Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Cocaine Use Disorder.

• Ability to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study.
• Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) diagnostic criteria for CUD and report recent cocaine use (verified by at least one positive urine drug screen (UDS) for the cocaine metabolite benzoylecgonine…
• Have body mass index (BMI) of ≥25 kg/m2
• Agree (if the participant is female and of child-bearing potential) to use effective contraceptive methods, unless the participant's male partner(s) is surgically sterile (underwent vasectomy).

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide; Placebo; cognitive behavioral therapy (CBT).

Registered summary

The purpose of this study is to evaluate semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), in combination with cognitive behavioral therapy (CBT) for the treatment of cocaine use disorder (CUD). This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/).

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Mild Autonomous Cortisol Secretion (MACS); Autonomous Cortisol Secretion (ACS); Subclinical Cushing's; Mild Autonomous Cortisol Excess.

• Adults ≥18 years
• MACS groups: adrenal adenoma + DST cortisol >1.8 µg/dL + no overt Cushing + eligible for adrenalectomy
• Willingness to postpone surgery 6 months if randomized
• Controls: no adrenal abnormalities + normal DST + BMI ≥27 + ≥2 cardiometabolic conditions

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Intervention 1: Adrenalectomy; Intervention 2: Semaglutide

Registered summary

The goal of this study is to learn how two treatments-adrenalectomy (surgical removal of an adrenal gland) and semaglutide (a medication used for weight management)-affect insulin resistance and cortisol regulation in adults with mild autonomous cortisol secretion (MACS). The study will also learn how these treatments impact body composition, blood pressure, cholesterol, inflammation, muscle strength, and quality of life. The main questions the study aims to answer are: 1. Does adrenalectomy or semaglutide improve insulin resistance more in people with MACS? 2. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Obesity.

• Male or female.
• Age 18 years or above at the time of signing the informed consent.
• BMI between 25.0 and 45 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Diagnosed with type 2 diabetes (T2D) more than (>) 180 days before screening.

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Liraglutide; Oral Semaglutide; Semaglutide

Registered summary

The purpose of this study is to investigate how the duration of fasting and temporary stopping of Glucagon-Like-Peptide 1 (GLP-1) medications affect the amount of food left in the stomach in people using liraglutide (injected), semaglutide (taken by mouth) or semaglutide (injected). The length of participants participation in the study will depend on the type of GLP-1 RA treatment participants are already using.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Pre-Diabetes; Weight, Body; Cardiovascular Diseases.

• Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before the screening visit, documented by an acceptable modality in the last 6 months.
• Age ≥ 18 years old
• Body Mass Index (BMI)=25-40 kg/m2
• Glycated Hemoglobin (HbA1c) = 5.7-6.4%

12 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Placebo; Rybelsus Tablet; Jardiance 25Mg Tablet; Metformin; Actos

Registered summary

The investigators are studying how to help people with prediabetes (Pre-DM) and obesity. The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight. The investigators also want to reduce participants risk of heart problems. The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 60. Conditions: Overweight and/or Obesity.

• To be eligible for study participation, all subjects must meet all the following inclusion criteria:
• Medically healthy with no clinically significant medical history, vital sign, or coagulation results at Screening; chemistry, hematology, or urinalysis at Screening and Day -1 (SAD)/Day 0 (MD) as deemed by the Investigator
• Age 18 to 60 years, inclusive, at the time of Screening
• Body mass index ≥25 to <35 kg/m2 if participating in the SAD phase or ≥27 to <40 kg/m2 if participating in the MD phase, at the time of Screening

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

VX-201; semaglutide SC

Registered summary

VX-201-101 is a first-in-human Phase 1 clinical study evaluating VX-201, a needle-free microneedle (MN) array patch (MAP) that delivers semaglutide through the skin as an alternative to subcutaneous (SC) injection.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists male participants 30 to 79. Conditions: Prostate Carcinoma; Recurrent Prostate Carcinoma.

• Documented informed consent of the participant
• English, Spanish or Mandarin-speaking
• Agreement to allow the use of archival tissue from diagnostic tumor biopsies
• If unavailable, exceptions may be granted with study principal investigator (PI) approval

9 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Antiandrogen Therapy; Behavioral Intervention; Biospecimen Collection; Cardiac Computerized Tomographic Angiography; Computed Tomography; Electronic Health Record Review; Internet-Based Intervention; Lifestyle Counseling; Medical Device Usage and Evaluation; Nutritional Intervention; Nutritional Intervention; Questionnaire Administration; Radiation Therapy; Referral; Semaglutide; Short-Term Fasting; Tirzepatide

Registered summary

This phase II trial compares the effect of time-restricted eating (TRE) and glucagon-like peptide-1 (GLP1) receptor agonists (RA), semaglutide and tirzepatide, to an American Heart Association (AHA) heart healthy diet (HHD) intervention on heart and blood vessel health (cardiovascular system) and how the body processes food for energy (metabolic system) in prostate cancer patients undergoing androgen deprivation therapy (ADT). Prostate cancer patients who are receiving hormonal therapy (ADT) are at an increased risk of cardiovascular disease. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 65. Conditions: Overweight; Obesity.

• Male or female participants aged ≥18 years and ≤ 65 years.
• Body Mass Index (BMI) at screening between 27.0 and 35.0 kg/m² (inclusive).
• Weight change of no more than ±5% during the 3 months prior to screening with diet and exercise alone (self-reported).
• Participants (including males) must have no plans for conception during the study and within 3 months after the last administration, and must agree to use effective contraceptive methods and refrain from donating sperm or eggs during this…

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide Nasal Spray; Placebo; Semaglutide Injection

Registered summary

The specific aim of this study is to examine the Safety, Tolerability and Pharmacokinetic of Semaglutide Nasal Spray compared with placebo and positive control in Adult Overweight or Obese Participants.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 30. Conditions: Diabetes type1; Obesity.

• Age 18-30 years with T1D whose BMI meets FDA approval criteria for anti-obesity pharmacotherapy (BMI ≥30 kg/m2 alone or BMI ≥27 kg/m2 with a weight-related comorbidity)
• Clinical diagnosis of T1D
• Diabetes duration diagnosed ≥ 12 months ago
• HbA1c ≤10% at screening and within the past 90 days

10 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Semaglutide Pen Injector; Placebo

Registered summary

More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. GLP-1 analogues are anti-obesity medications that are cardioprotective in adults with type 2 diabetes, however evaluation of these agents in people with T1D has been limited to glycemic outcomes. Investigators aim to study the impact of GLP-1 analogue obesity treatment on markers of cardiometabolic risk in young adults with T1D and obesity.

Where, as registered

1 US site in 1 state.