A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
- Registration Number
- NCT06972459
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO.
Participation in the study will last about 18 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
-
Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:
- hypertension
- dyslipidemia
- obstructive sleep apnea, or
- cardiovascular disease
-
Have a history of at least one unsuccessful dietary effort to lose body weight
- Have type 1 diabetes, type 2 diabetes, or any other types of diabetes
- Have an unstable body weight within 90 days prior to screening
- Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening
- Have acute or chronic hepatitis or pancreatitis
- Are taking other medications or alternative remedies to manage weight loss
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 1 Orforglipron Participants will receive orforglipron orally Orforglipron Dose 2 Orforglipron Participants will receive orforglipron orally Orforglipron Dose 3 Orforglipron Participants will receive orforglipron orally Orforglipron Dose 4 Orforglipron Participants will receive orforglipron orally Placebo Placebo Participants will receive placebo orally
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 40
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight at Week 72 Baseline, Week 72 Percentage of Participants Achieving Weight Reduction of ≥5% Baseline up to 72 weeks Change from Baseline in Waist Circumference Baseline up to 72 weeks Change from Baseline in Body Max Index (BMI) Baseline, Week 72 Change from Baseline in Systolic Blood Pressure (SBP) Baseline up to 72 weeks Percent Change from Baseline in Triglycerides Baseline up to 72 weeks Change from Baseline in Hemoglobin A1c (HbA1c) Baseline up to 72 weeks Change from Baseline in EQ-5D-5L Baseline, Week 72 Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron Predose through Week 48
Trial Locations
- Locations (88)
Novak Clinical Research - Tucson - North La Cholla Boulevard
🇺🇸Tucson, Arizona, United States
Norcal Endocrinology & Internal Medicine
🇺🇸San Ramon, California, United States
Southern California Clinical Research
🇺🇸Santa Ana, California, United States
Care Access - Thousand Oaks
🇺🇸Thousand Oaks, California, United States
Accel Research Sites - DeLand Clinical Research Unit
🇺🇸DeLand, Florida, United States
Innovation Medical Research Center - Fort Lauderdale
🇺🇸Fort Lauderdale, Florida, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
West Orange Endocrinology P.A.
🇺🇸Ocoee, Florida, United States
Care Access - Tampa
🇺🇸Tampa, Florida, United States
Accel Research Sites - NeuroStudies Clinical Research Unit
🇺🇸Decatur, Georgia, United States
Scroll for more (78 remaining)Novak Clinical Research - Tucson - North La Cholla Boulevard🇺🇸Tucson, Arizona, United StatesThili KulatilakePrincipal Investigator