Orforglipron trials recruiting now

Who the trial lists, as registered

Lists people 18 and older. Conditions: Overweight; Prediabetic State; Prehypertension; Obesity, Abdominal.

• Have an increased waist-to-height ratio of ≥0.5
• Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia)
• Have at least one unsuccessful attempt to reduce body weight based on diet and exercise
• Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds

The exclusion criteria are on the listing.

What it tests, as registered

Orforglipron; Placebo

Registered summary

This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.

Where, as registered

80 US sites in 31 states; also Argentina (20), South Korea (12), China (11), Germany (10), Spain (10), India (9), Mexico (9), Czechia (7), Taiwan (5), Japan (4), Puerto Rico (3).

Who the trial lists, as registered

Lists people 6 to 17. Conditions: Obesity; Overweight.

• Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.
• Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]); OR
• Applies to participant age between 12 and <18 years old. Overweight as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart (CDC-NCHS, 2022), and at…
• hypertension

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

What it tests, as registered

Orforglipron; Placebo

Registered summary

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Where, as registered

50 US sites in 28 states; also Japan (9), Poland (9), Italy (7), United Kingdom (7), Israel (6), Mexico (6), Spain (6), South Korea (4), Belgium (3), Brazil (3), China (3), Portugal (3).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Peripheral Arterial Disease.

• Have symptomatic PAD with intermittent claudication of Fontaine Stage II
• Have an Ankle Brachial Index (ABI) of 0.9 or less

The exclusion criteria are on the listing.

What it tests, as registered

Orforglipron; Placebo

Registered summary

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.

Where, as registered

36 US sites in 14 states; also Japan (25), China (18), Argentina (13), India (11), Australia (9), Brazil (8), Poland (8), Canada (7), France (7), Greece (6), United Kingdom (5), Israel (4), South Korea (4), Taiwan (4), Netherlands (3), Puerto Rico (1), Slovakia (1).

Who the trial lists, as registered

Lists female participants 18 and older. Conditions: Urinary Incontinence,Stress.

• Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening
• Have a diagnosis of stress urinary incontinence

The exclusion criteria are on the listing.

What it tests, as registered

Orforglipron; Placebo

Registered summary

The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2. Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity or overweight. SUI is leaking urine during movement or activity such as coughing or exercising. Participation in the study will last about 58 weeks from screening to safety follow-up.

Where, as registered

21 US sites in 11 states; also China (21), Japan (20), Romania (16), India (15), Mexico (13), Czechia (9), Canada (8), South Korea (7), Poland (6).

Who the trial lists, as registered

Lists people 10 to 17. Conditions: Diabetes Mellitus, Type 2.

• Have type 2 diabetes treated with diet and exercise and metformin and/or basal insulin
• Have HbA1c > 6.5% to ≤ 11.0% at screening
• Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of >85th percentile

The exclusion criteria are on the listing.

What it tests, as registered

Orforglipron; Dulaglutide

Registered summary

This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them. Participation in the study will last about 61 weeks.

Where, as registered

17 US sites in 10 states; also Japan (11), India (8), Brazil (7), Italy (7), Mexico (5), South Korea (5), Belgium (3), Spain (3), United Kingdom (3), Taiwan (2).

Who the trial lists, as registered

Lists people 12 to 17. Conditions: Obesity; Overweight.

• Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.
• Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]); OR
• Overweight as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,
• hypertension

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

What it tests, as registered

Orforglipron; 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 orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months. Participants who have completed the primary PW01 study (including the 4-week safety follow-up period) will have the opportunity to receive an additional 156 weeks of treatment with orforglipron as well as continuing the lifestyle intervention.

Where, as registered

12 US sites in 10 states; also Japan (9), Poland (4), Israel (3), Italy (3), United Kingdom (3).

Who the trial lists, as registered

Lists people 50 and older. Conditions: Atherosclerosis Cardiovascular Disease; Chronic Kidney Disease.

• Have established ASCVD and/or CKD

The exclusion criteria are on the listing.

What it tests, as registered

Orforglipron; Placebo

Registered summary

The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.

Where, as registered

No US site; Argentina (59), Mexico (35), Brazil (34), China (30), Netherlands (23), India (20), Poland (20), Romania (20), Canada (19), Ukraine (19), Israel (17), South Korea (17), Belgium (16), Australia (15), Hungary (15), Italy (15), Spain (15), Taiwan (15), Turkey (Türkiye) (15), Czechia (14), France (13), Colombia (12), Slovakia (11), Bulgaria (10), Japan (10), Philippines (10), Austria (8), Germany (8), Greece (8), United Kingdom (8), Lithuania (7), New Zealand (6), South Africa (5), Estonia (4), Malaysia (4), Serbia (4), Thailand (3), Tunisia (2).

Who the trial lists, as registered

Lists people 18 to 65. Conditions: Diabetes Mellitus, Type 2; Diabetes Melletus; Glucose Metabolism Disorders; Metabolic Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior; Fasting; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Receptors, Peptide.

• Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.
• Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol/mol)) to less than 9.5% (91 mmol/mol) at screening.
• Intend to be compliant with the fast during the Ramadan period.
• Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.

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

What it tests, as registered

Orforglipron

Registered summary

The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.

Where, as registered

No US site; South Africa (14), Saudi Arabia (10), India (9), United Arab Emirates (7).

Who the trial lists, as registered

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

• Aged 18 to 55 years, inclusive.
• For Part A: BMI ≥20 and <30 kg/m\^2 and body weight ≥50 kg.
• For Part B: BMI ≥24 and ≤40 kg/m\^2, with stable body weight during the 3 months prior to screening.
• Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.

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

What it tests, as registered

Orforglipron; Matching Placebo; IBI3042

Registered summary

This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity. The study has two parts. Part A will evaluate single doses of IBI3042 in healthy adults. Part B will evaluate repeated doses for 13 weeks in adults with overweight or obesity. The main goal is to assess the safety and tolerability of IBI3042. The study will also evaluate how IBI3042 is processed in the body and explore its effects on body weight and other metabolic measures. The full summary is on the listing.

Where, as registered

No US site; China (1).

Who the trial lists, as registered

Lists people 18 to 80. Conditions: Obesity.

• Age 18-80 years at screening
• History of BMI ≥30 kg/m²
• Current or recent (within 8 weeks) treatment with injectable semaglutide, tirzepatide, or similar GLP-1 based medication
• Achieved ≥10% body weight loss since initiation of injectable semaglutide, tirzepatide or similar GLP-1 based medication

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

What it tests, as registered

Phentermine Pill; Orforglipron

Registered summary

This study will compare the effect of orforglipron and phentermine on weight maintenance.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

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

• Have body mass index (BMI) ≥28.0 kilograms per square meter (kg/m2) and <30 kg/m2 or ≥24.0 kg/m2 and <28 kg/m2, and at least 1 of the following weight-related comorbidities at screening:
• hypertension
• dyslipidemia
• obstructive sleep apnea

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

What it tests, as registered

Orforglipron; Placebo

Registered summary

The purpose of this study is to learn how well orforglipron works and how safe it is in Chinese adults with obesity or overweight and related health problems. Participation in this study will last about 53 weeks (about 1 year).

Where, as registered

No US site; China (13).

Who the trial lists, as registered

Lists people 18 to 79. Conditions: Diabete Type 2; Pharmacogenomic Drug Interaction.

• Adult male or non-pregnant female volunteers (Age 18-79)
• Not currently taking more than two home oral antidiabetic agents, with or without a diagnosis of type 2 diabetes
• Able and willing to stop home oral antidiabetic medications for 5 days prior to the start of the study, with approval from healthcare providers
• Able and willing to give informed consent

The exclusion criteria are on the listing.

What it tests, as registered

Orforglipron

Registered summary

This research study aims to learn about how the body responds to food through different genetic pathways and how these responses may change during a short course of orforglipron. Orforglipron is an oral glucagon-like peptide-1 (GLP-1) receptor agonist that was approved by the U.S. Food and Drug Administration (FDA) on April 1, 2026, for long-term weight management. In longer studies, it has helped people lose weight and improve blood sugar, blood pressure, and cholesterol. The full summary is on the listing.

Where, as registered

No sites listed yet.