Tirzepatide trials recruiting now

Who the trial lists, as registered

Lists people 18 and older. Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease.

• Have liver fat content ≥8%
• Have ELF score of ≥9 and ≤10.8 at screening
• Have VCTE LSM ≥10 kilopascal (kPa) and <20 kPa at screening

The exclusion criteria are on the listing.

What it tests, as registered

Tirzepatide; Retatrutide; Placebo

Registered summary

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The full summary is on the listing.

Where, as registered

141 US sites in 35 states; also Japan (65), China (40), Brazil (26), India (21), South Korea (20), Mexico (19), Argentina (17), United Kingdom (17), Australia (16), France (16), Canada (15), Poland (15), Taiwan (15), Germany (13), Spain (13), Italy (12), Belgium (11), Israel (11), Ukraine (11), Turkey (Türkiye) (8), Netherlands (6), Austria (5), Romania (5), Czechia (4), Bulgaria (3), Hong Kong (3), Hungary (3), New Zealand (3), Norway (2), Portugal (2), Puerto Rico (2), Switzerland (2), Sweden (1).

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Obesity; Overweight.

• Have a body mass index (BMI)
• ≥30 kilogram/square meter (kg/m²), or
• ≥27 kg/m² and <30 kg/m², or with at least 1 weight-related comorbidity
• Have had a stable body weight for the 3 months prior to randomization (<5%) body weight gain and/or loss.

The exclusion criteria are on the listing.

What it tests, as registered

LY3305677; LY3841136; Tirzepatide; LY3549492; LY3532226; Placebo; Placebo

Registered summary

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

Where, as registered

50 US sites in 22 states; also Argentina (7).

Who the trial lists, as registered

Lists people 6 to 11. Conditions: Obesity.

• Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive)
• Have:
• a body weight of ≥ 40 kilograms (kg) (88 pounds), and
• been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart

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

What it tests, as registered

Tirzepatide; Placebo

Registered summary

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks. Participants who have completed the primary 104-week PW02 study (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Where, as registered

41 US sites in 23 states; also Poland (8), Israel (6), Spain (6), Italy (5), Mexico (4), Belgium (3), Portugal (3), South Korea (3), Taiwan (3).

Who the trial lists, as registered

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

• Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner or physician assistant)
• Have body mass index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m² to <30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes…
• Must have initiated treatment with ixekizumab for approximately 3 months (± 1 month) prior to decision to add tirzepatide.
• Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline/screening).

The exclusion criteria are on the listing.

What it tests, as registered

Tirzepatide

Registered summary

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.

Where, as registered

39 US sites in 22 states.

Who the trial lists, as registered

Lists people 18 to 70. Conditions: Ulcerative Colitis; Obesity or Overweight.

• Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.
• Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.
• Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
• Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\]

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

What it tests, as registered

Mirikizumab; Mirikizumab; Tirzepatide; Placebo

Registered summary

The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

Where, as registered

37 US sites in 23 states; also Mexico (16), Brazil (15), Poland (12), Spain (10), France (9), Italy (9), Turkey (Türkiye) (9), Israel (8), Belgium (6), Canada (6), Czechia (6), Denmark (6), Germany (6), Romania (6), Netherlands (5), Greece (4), Hungary (4), Slovakia (4), United Kingdom (4), Austria (3), Bulgaria (1), Puerto Rico (1).

Who the trial lists, as registered

Lists people 18 to 70. Conditions: Crohn's Disease; Obesity or Overweight.

• Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
• Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to <30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:
• hypertension
• Type 2 diabetes mellitus (T2DM)

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

What it tests, as registered

Mirikizumab; Mirikizumab; Tirzepatide; Placebo

Registered summary

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.

Where, as registered

35 US sites in 22 states; also Mexico (16), Brazil (15), Poland (12), France (10), Spain (10), Italy (9), Turkey (Türkiye) (9), Israel (8), Canada (7), Belgium (6), Czechia (6), Denmark (6), Germany (6), Romania (6), Netherlands (5), Greece (4), Hungary (4), Slovakia (4), Austria (3), Bulgaria (1), Puerto Rico (1).

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 12 to 17. Conditions: Obesity; Weight Gain.

• Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension,…
• Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
• Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).

The exclusion criteria are on the listing.

What it tests, as registered

Tirzepatide; Placebo

Registered summary

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. The full summary is on the listing.

Where, as registered

14 US sites in 8 states; also United Kingdom (9), Israel (8), France (7), Argentina (6), Mexico (5), Spain (5), Australia (4), Taiwan (4), Canada (3), Germany (3), Puerto Rico (1).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Opioid Use Disorder; Opioid Use Disorder, Moderate; Opioid Use Disorder, Severe.

• Must be ≥18 years of age;
• Must have moderate to severe OUD;
• Must, at the time of randomization, be newly initiated on BUP (i.e., within 7 to 80 days) during the current treatment episode, be taking ≥ 8 mg/day of generic buprenorphine-naloxone film/tablets (or the equivalent for other buprenorphine…
• Must be willing to be randomized to tirzepatide or placebo and to comply with study procedures, including weekly visits for 6 months;

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

What it tests, as registered

Tirzepatide; Placebo

Registered summary

The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.

Where, as registered

9 US sites in 7 states.

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

• Homozygous for the PNPLA3 p.I148M genotype
• Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 3
• Has a Body Mass Index (BMI) ≥30 to <45 kg/m\^2 at visit 2
• Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 × Upper Limit of Normal (ULN) as described in the protocol

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

What it tests, as registered

ALN-PNP; Tirzepatide; Placebo

Registered summary

This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty liver disease. ALN-PNP reduces the amount of Patatin-like phospholipase domain-containing protein 3 (PNPLA3), a protein that liver cells make, which may help decrease liver fat if there is an abnormal PNPLA3 protein. The goal of this study is to understand the effect of ALN-PNP with or without tirzepatide on reducing liver fat. The full summary is on the listing.

Where, as registered

9 US sites in 5 states.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Hormone Receptor-Positive Breast Cancer; HER2-Negative Breast Cancer.

• Consent: Be willing and able to provide written informed consent for the trial.
• Age: Male or Female patients aged 18 years or older.
• Breast Cancer Diagnosis: Have hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer previously diagnosed by biopsy.
• Stage: Have previously untreated early-stage, clinical or anatomic stage I, II, or III hormone receptor-positive breast cancer.

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

What it tests, as registered

Tirzepatide

Registered summary

This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5% or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The study will also assess the safety and tolerability of tirzepatide, its feasibility based on discontinuation rates, and completion of treatment. The full summary is on the listing.

Where, as registered

7 US sites in 1 state.

Who the trial lists, as registered

Lists female participants 18 and older. Conditions: Endometrial Cancer.

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Obesity (defined as BMI ≥ 30 kg/m2) OR Overweight (defined as BMI ≥ 27 kg/m2) with presence of ≥1 weight related comorbid condition OR a diagnosis of Type 2 Diabetes Mellitus with BMI ≥ 25 kg/m2
• Type 2 Diabetes Mellitus is defined as known history of Type 2 diabetes, HbA1c ≥ 6.5%, fasting blood glucose ≥126 mg/dL on 2 occasions, or random blood glucose ≥ 200 mg/dL with signs and symptoms of diabetes mellitus (weight loss, fatigue,…

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

What it tests, as registered

Tirzepatide

Registered summary

The researchers are doing this study is to find out whether tirzepatide and semaglutide are practical (feasible) for weight management and blood sugar control for endometrial cancer patients undergoing chemotherapy. The researchers will also look at participants' experience with the study drug, the safety of taking the study drug while receiving chemotherapy, and changes in weight, body fat composition, and blood pressure of participants.

Where, as registered

7 US sites in 2 states.

Who the trial lists, as registered

Lists people 21 to 65. Conditions: Smoking Cessation; Smoking Behaviors.

• Age 21-65 years
• Body mass index ≥ 25kg/m2 at the baseline screening
• Reporting ≥10 cigarettes per day, on average, for the past 6 months and > 2 year duration of smoking
• Interest in making a long-term cessation attempt within the next 30-60 days

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

What it tests, as registered

Tirzepatide; Placebo

Registered summary

This multi-site clinical trial will generate data on the efficacy of tirzepatide for smoking cessation and associated outcomes (e.g., post-cessation weight gain) in treatment-seeking people who smoke (PWS) with overweight or obesity. A sample of 300 treatment-seeking people who smoke with body mass index of 25 kg/m2 or greater will be recruited from four geographic sites (University of Southern California, Yale University, University of Chicago, and University of Colorado Anschutz Medical Campus) to participate in a parallel-arm, dose-escalating, placebo-controlled trial. The full summary is on the listing.

Where, as registered

4 US sites in 4 states.

Who the trial lists, as registered

Lists people 18 to 80. Conditions: Crohn Disease (CD).

• Subjects 18 to 80 years of age, inclusive, at the time of consent
• Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology
• Active ileal or ileocolonic inflammation on colonoscopy defined as
• Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must have been at least 6 months optimized on most recent therapy without corticosteroids.

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

What it tests, as registered

Tirzepatide; Standard of care treatment

Registered summary

The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. The full summary is on the listing.

Where, as registered

3 US sites in 3 states.

Who the trial lists, as registered

Lists people 18 to 26. Conditions: Prader-Willi Syndrome; Hypothalamic Obesity; Obesity/Therapy.

• Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) with either 1) genetically confirmed diagnosis of PWS, 2) hypothalamic obesity as defined by damage to the medial hypothalamic…
• In a stable care setting at least 6 months prior to enrollment
• Able and willing to participate in study visits including tolerating blood draws, urine samples and tolerate DXA scan.
• Ability to take weekly subcutaneous tirzepatide

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

What it tests, as registered

Tirzepatide

Registered summary

This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and/or hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication for 1 year to see how weight and other health factors are effected by the medication.

Where, as registered

3 US sites in 3 states.

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Type 2 Diabetes (Adult Onset).

• Ability of subject to understand and the willingness to sign a written informed consent document.
• Males and females; Age 18-75 years
• Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients
• Drug naïve or receiving metformin monotherapy

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

What it tests, as registered

Tirzepatide; Pioglitazone; Sitagliptin; Metformin HCI XR

Registered summary

The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.

Where, as registered

2 US sites in 1 state.

Who the trial lists, as registered

Lists people 30 to 70; healthy volunteers accepted. Conditions: Diabetes Mellitus, Type 2; Diabetes; Type 2 Diabetes; Pre Diabetes.

• Age: 30 to 70 years old.
• Diagnosis of Type 2 Diabetes (T2D): Based on a previous diagnosis or confirmed by laboratory testing at screening (A1c > 5.7% or fasting glucose > 100 mg/dL).
• HbA1c Range: Between 5.7% and 8%, with a stable medication or lifestyle regimen for at least 3 months.
• BMI: Between 19 and 24.9 kg/m².

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

What it tests, as registered

Insulin resistance testing; OGTT; Fat biopsy; DXA scan; MRI; 1H-MRS; Tirzepatide; Pioglitazone

Registered summary

This study is to investigate how adipocyte (fat cell) function and fat distribution differ between individuals with normal-weight type 2 diabetes (NWD), those with overweight type 2 diabetes (OWD), and normal-weight controls without diabetes (NWC). The study will assess whether adipocyte-directed therapies, specifically pioglitazone and tirzepatide, can improve insulin resistance, adipocyte function, and fat distribution in individuals with NWD. The full summary is on the listing.

Where, as registered

2 US sites in 1 state.

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 tirzepatide for at least 4 weeks.

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

What it tests, as registered

Tirzepatide; Zenagamtide

Registered summary

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

Where, as registered

2 US sites in 2 states.

Who the trial lists, as registered

Lists people 18 to 50. Conditions: Musculoskeletal Abnormalities; Obesity; Sarcopenic Obesity; Osteoporosis; Drug Effect.

• Subjects will have a BMI between 30kg/m2
• 40kg/m2 (inclusive)
• Be between 18 and 50 years of age (inclusive).
• Non-Hispanic Black males and females will be enrolled at PBRC.

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

What it tests, as registered

Tirzepatide; Lifestyle toolkit

Registered summary

The GRAMS study objectives are to assess the musculoskeletal changes that occur after weight loss using GLP-1 based therapy. A lifestyle intervention with diet and exercise is included to assess any mitigating effects are provided, versus a control group with regular exercise and diet.

Where, as registered

2 US sites in 2 states.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Alcohol Use Disorder (AUD).

• English speaking adults aged 18 and above
• Diagnosed with current DSM-5 alcohol use disorder
• Willing and able to physically travel to BWH CCI outpatient facilities for study visits

The exclusion criteria are on the listing.

What it tests, as registered

Tirzepatide; Saline Placebo

Registered summary

This is a pilot, 4-week, double-blind, placebo-controlled, randomized trial of individuals with alcohol use disorder (AUD) to receive weekly injections of either tirzepatide (n=10) or matching placebo (n=10). The primary aim is to determine the effects of tirzepatide on cue-reactivity among individuals with AUD. The secondary aim is to assess the safety and preliminary efficacy of tirzepatide for AUD.

Where, as registered

2 US sites in 1 state.

Who the trial lists, as registered

Lists people 18 to 80. Conditions: Central Centrifugal Cicatricial Alopecia (CCCA).

• Age 18 to 80 years.
• Clinical and/or biopsy-confirmed diagnosis of central centrifugal cicatricial alopecia (CCCA).
• Active CCCA, defined as a C-CAT disease activity score greater than 1.
• No treatment for CCCA during the 6 weeks before enrollment.

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

What it tests, as registered

Tirzepatide

Registered summary

The goal of this pilot clinical trial is to learn if tirzepatide can treat active central centrifugal cicatricial alopecia (CCCA), a type of permanent scarring hair loss, in adults. The main questions it aims to answer are: * Does tirzepatide improve the symptoms and signs of active CCCA? * Does tirzepatide change the activity of genes in the scalp, especially genes related to scarring? * Does tirzepatide promote hair regrowth? Participants will: * Inject tirzepatide once a week for 12 months. * Visit the clinic for scalp examinations, photographs, and other health assessments. The full summary is on the listing.

Where, as registered

2 US sites in 1 state.

Who the trial lists, as registered

Lists people 21 to 65. Conditions: Alcohol Use Disorder (AUD).

• Enrollment in 14AA0181.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, ages 21-65 years old.
• Ability to understand and willingness to sign a written informed consent document.

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

What it tests, as registered

Tirzepatide; Placebo; [11C]raclopride plus drug; [11C]NNC-112

Registered summary

Background: Glucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss. They may also help reduce cravings for drugs and alcohol. Researchers want to know if a GLP-1 drug (tirzepatide) can lessen the urge to drink in people with alcohol use disorder (AUD). Objective: To learn how the brains of people with AUD respond to a GLP-1 drug. Eligibility: People aged 21 to 65 years with AUD who are non-treatment seeking. They must be enrolled in protocol 14-AA-0181. Healthy volunteers are also needed. Design: This study consists of Part 1 and Part 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 to 65. Conditions: Autosomal Dominant Polycystic Kidney; Obesity.

• 18-65 years of age
• ADPKD diagnosis based on the modified Pei-Ravine criteria
• Body-mass index of ≥27 kg/m\^2
• Estimated glomerular filtration rate ≥ 30 mL/min/1.73m\^2

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

What it tests, as registered

Tirzepatide; Placebo

Registered summary

The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to glucose and insulin, can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat and kidney metabolism using cutting-edge images techniques. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 40 to 80. Conditions: Type II Diabetes; Atherosclerosis.

• Male or female 40 years to 80 years of age at signing of informed consent
• Type 2 DM of minimum 5 years duration with HbA1c ≥7.0% to ≤10.5%
• Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)
• Presence of two discrete coronary artery plaques with visual diameter stenosis >20% on CCTA

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

What it tests, as registered

Tirzepatide; Placebo

Registered summary

A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV Study evaluating the effects of tirzepatide on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of type II Diabetes (T2DM) and atherosclerosis.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 21 to 100. Conditions: Metabolic Alcohol-associated Liver Disease; Alcohol Use Disorder.

• Age 21 or older
• Ability to provide written informed consent
• Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception including use of oral contraceptives and an additional barrier method of contraceptive such as condoms; use of an…
• Males: Agree to abstain or use accepted form of contraception, such as condoms.

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

What it tests, as registered

Tirzepatide; Placebo

Registered summary

Background: People with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake. Objective: To test Tirzepatide in people with AUD and MetALD. Eligibility: People aged 21 years and older with AUD and MetALD. Design: Participants will be screened. They will have a physical exam with blood and urine tests. 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 and Overweight; Binge Eating Disorder.

• Have a BMI ≥30 kg/m2 or ≥27 kg/m2
• previously diagnosed with at least one obesity-related comorbidity:
• Have at least one self-reported unsuccessful dietary effort to lose body weight
• Meet Diagnostic and Statistical Manual (DSM)-5 criteria for Binge Eating Disorder (BED) as diagnosed by the Eating Disorder Examination interview and confirmed by binge-eating diaries that is moderate or greater in severity (4 or more…

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

What it tests, as registered

Tirzepatide; Lisdexamfetamine Dimesylate; Guided self-help cognitive behavioral therapy; Placebo (oral); Placebo (injection)

Registered summary

The purpose of this study is to assess the efficacy and safety of tirzepatide in adults with obesity and binge-eating disorder, comparing tirzepatide against placebo and lisdexamfetamine dimesylate. All participants will receive guided self-help cognitive behavioral therapy.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 80. Conditions: Atrial Fibrillation; Obesity.

• Sinus rhythm at randomization
• Sustained normal sinus rhythm (or)
• Normal sinus rhythm at office visit
• Age ≥18 to ≤80 years old

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

What it tests, as registered

Tirzepatide; Placebo

Registered summary

This is a single center randomized double blind controlled study of patients (BMI ≥ 27 kg/m2) with obesity and Atrial Fibrillation (AFIB) randomized to Tirzepatide vs. placebo. It is expected that the significant weight loss with Tirzepatide will result in improved control, management, symptom severity, and burden of AFIB at 12 months.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 55 to 70. Conditions: Aging; LONGEVITY 1.

• Age 55-70 years
• BMI ≥ 30 kg/m² or ≥ 27 kg/m² if also with ≥ 1 weight-related comorbidity
• If taking anti-inflammatory or blood-pressure-/lipid-/glucose-lowering medications, no change in dose for ≥12 weeks prior to entry and no plans to dose escalate for the study duration
• Willing and able to provide written informed consent and undergo all required study procedures

The exclusion criteria are on the listing.

What it tests, as registered

Zepbound

Registered summary

This pilot clinical study aims to investigate the potential effects of tirzepatide on biological aging in older adults. In this novel study, 90 adults aged 55-70 years with an indication for tirzepatide weight-loss therapy will be randomized to receive either tirzepatide 2.5 mg subcutaneously (SC) weekly or no drug for 24 weeks, followed by 12 weeks off the drug. Since tirzepatide is already recognized as a highly effective weight-loss agent in this population, the primary focus will not be on measuring weight loss. 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: Chronic Weight Management.

• Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site.
• Are between 18 and 65 years of age (both inclusive) at time of screening.
• No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.

The exclusion criteria are on the listing.

What it tests, as registered

ASC35 Injection B, for subcutaneous use; ASC35 Placebo Injection B, for subcutaneous use; Tirzepatide

Registered summary

This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 70; healthy volunteers accepted. Conditions: Obesity; Overweight and Obesity; Overweight.

• nondiabetic as defined by fasting plasma glucose < 126 mg/dL while off all glucose lowering medications
• BMI 27-39.9 kg/m2. Individuals with obesity (BMI 30-39.9 kg/m2) are not required to have an additional risk factor but those who are overweight (27-29.9 kg/m2) must have at least one weight-related factor as follows: hypertension defined…
• Age 18-70
• Pre and postmenopausal women will be eligible and details of last menstrual period and/or hormone replacement collected for statistical adjustment and formal testing for effect modification.

The exclusion criteria are on the listing.

What it tests, as registered

Tirzepatide

Registered summary

Obesity, affecting 40% of US adults and costing 173b annually, represents a significant health care burden (1). It is associated with increased risk for multiple chronic diseases including hypertension, type 2 diabetes (T2D), cardiovascular disease, and NAFLD, as well as cancer, osteoarthritis, and obstructive sleep apnea. 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.

• BMI ≥30 kg/m2 or ≥27kg/m2 with at least one weight-related medical condition
• Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
• Have an established primary care provider

The exclusion criteria are on the listing.

What it tests, as registered

Bimagrumab; Tirzepatide; Calcium/Vitamin D; Lifestyle and nutrition counseling

Registered summary

In adults with obesity seeking treatment, weight loss would ideally be composed almost exclusively of fat mass. However, loss of muscle mass and bone are unintentional consequences of weight loss, which may have negative effects on health by lessening improvements in glucose and insulin levels, reducing resting metabolic rate, and increasing the risk of falls and fractures. 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 60. Conditions: Idiopathic Intracranial Hypertension (IIH).

• Signs and symptoms of increased intracranial pressure:
• headaches, tinnitus, visual obscurations, papilledema;
• absence of localizing findings on neurological examination (except for VI nerve palsy);
• no secondary causes identified on imaging, e.g., hydrocephalus, space- occupying lesion;

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

What it tests, as registered

Tirzepatide; Tirzepatide Placebo

Registered summary

This will be a randomized, double-blind, parallel, placebo-controlled trial of 60 participants. The primary analysis will be a statistical comparison of the estimates of the mean difference in the 12-month change in intracranial pressure (ICP) between participants assigned to the tirzepatide and Placebo arms in 1:1 randomization using the intention-to-treat (ITT) population. Hypothesis testing will be performed using analysis of covariance (ANCOVA), with the treatment indicator as the independent variable and the 12-month change in ICP as the dependent variable. The full summary is on the listing.

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 and older. Conditions: Obesity and Obesity-related Medical Conditions; Bariatric Surgery.

• adults who have been enrolled in the multidisciplinary metabolic and bariatric surgery program at the UK HealthCare Weight Loss Surgery Clinic and are scheduled to receive laparoscopic or robotic sleeve gastrectomy, or gastric bypass…
• BMI greater than or equal to 40 kg/m2 with one or more obesity-related comorbidities
• have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing
• enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)

The exclusion criteria are on the listing.

What it tests, as registered

tirzepatide; Standard of Care

Registered summary

This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 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 40 and older. Conditions: Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction; Obesity.

• Diagnosis of heart failure (HF) per the ACC/AHA guidelines with NYHA class II-III symptoms
• Left ventricular ejection fraction >= 45% within 6 months of recruitment
• At least one of the following: elevated N-terminal pro- B-type natriuretic peptide (NT-proBNP) >=200 pg/ml (>=600 pg/ml with concurrent atrial fibrillation), evidence of structural heart disease (left atrial (LA) enlargement with LA volume…
• Body mass index (BMI) >30 kg/m2

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

What it tests, as registered

Tirzepatide

Registered summary

The central hypothesis to be tested is that patients with obesity and heart failure with preserved ejection fraction (HFpEF) prescribed tirzepatide will demonstrate reductions in measured plasma volume. In conjunction with state-of-the-art body composition analysis and measures of adipokines, this will establish an important mechanism of clinical benefit and inform disease pathophysiology. To accomplish this, this study will perform a 15-month prospective cohort study in 50 patients with obesity and HFpEF who clinically qualify for treatment with tirzepatide. 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: Breast Cancer; Breast Neoplasms; Breast Cancers.

• Female or male patients ≥18 years of age
• Have a diagnosis of node-positive, hormone receptor-positive (ER+ > 10%), and HER2-negative breast cancer within the past 15 years per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
• If patients have synchronous bilateral ER+ breast cancers, tissue from both primary cancers should be submitted for next-generation sequencing (NGS) to inform ctDNA testing
• Patients with multifocal/multicentric cancers are eligible and the largest focus of cancer should be submitted for NGS evaluation. If tested, all tumor foci must meet have ER > 10%

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

What it tests, as registered

Tirzepatide

Registered summary

This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk early breast cancer patients with obesity or overweight, inhibiting the growth and survival of micrometastatic disease and leading to clearance of tumor-informed circulating tumor DNA (ctDNA) and freedom from the development of metastatic disease.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 21 to 65. Conditions: Alcohol Use Disorder; Obesity and Overweight; Alcohol.

• Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)
• Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline
• Body mass index ≥ 27kg/m2
• Willingness to attend weekly medication visits and complete all study procedures

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

What it tests, as registered

Tirzepatide; Placebo injections

Registered summary

The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 12 to 24. Conditions: Obesity; Adolescent Obesity; Body-Weight Trajectory; Weight Loss Trajectory; Bariatric Surgery; Anti-obesity Agents.

• Signed and dated informed consent form
• Willingness to comply with all study procedures and availability for the duration of the study
• Male or female biological sex, age 12 through 24 years
• In the preoperative pathway for vertical sleeve gastrectomy

The exclusion criteria are on the listing.

What it tests, as registered

Injectable semaglutide or injectable tirzepatide; Standard postoperative care

Registered summary

The study plans to learn more about what happens to the body after bariatric surgery in people 12 to 24 years old. The study aims to understand why people respond differently to bariatric surgery and how to define success beyond weight loss alone. The study also plans to learn more about whether a medication (semaglutide or tirzepatide) can help people 12 to 24 years old who, between 6 and 24 months after bariatric surgery, have not lost as much weight as expected.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists female participants 46 to 60; healthy volunteers accepted. Conditions: Obesity; Menopause Hot Flashes.

• Females
• Age 46-60 years old.
• BMI ≥30 kg/m2 or BMI ≥27 kg/m2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
• Presence of bothersome hot flashes (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment).

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

What it tests, as registered

Tirzepatide; Placebo

Registered summary

The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 to 70. Conditions: Drug Discontinuation; Substance Use Disorders; Eating Behavior Changes; Tirzepatide.

• Aged 18-70 years.
• Currently on tirzepatide.
• Currently receiving care from University of Texas- Southwestern (UTSW) Weight Wellness Clinic.
• Cognitively capable of understanding and signing informed consent.

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

What it tests, as registered

Discontinuation and Reinitiation of Tirzepatide

Registered summary

The goal of this clinical study with research procedures is to learn how stopping and restarting tirzepatide (a medication that helps regulate blood sugar and appetite) affects brain activity, behavior, and health in adults ages 18-70 who are currently taking tirzepatide. The full summary is on the listing.

Where, as registered

1 US site in 1 state.