A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
- Conditions
- ObesityOverweightOverweight or Obesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT05869903
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3127
-
Have a BMI
-
≥30.0 kilogram/square meter (kg/m²),
-
≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:
- Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
-
-
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
- Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
- Have had a history of chronic or acute pancreatitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 1 Orforglipron Participants will receive orforglipron administered orally. Orforglipron Dose 2 Orforglipron Participants will receive orforglipron administered orally. Orforglipron Dose 3 Orforglipron Participants will receive orforglipron administered orally. Placebo Placebo Participants will be given placebo.
- Primary Outcome Measures
Name Time Method Mean Percent Change from Baseline in Body Weight Baseline to Week 72
- Secondary Outcome Measures
Name Time Method Mean Change from Baseline in Waist Circumference Baseline, Week 72 Mean Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 72 Mean Percent Change from Baseline in Fasting non-HDL Cholesterol Baseline, Week 72 Mean Percent Change from Baseline in Fasting Triglycerides Baseline, Week 72 Mean Change from Baseline in Hemoglobin A1c (HbA1c) % Baseline, Week 72 Mean Change from Baseline in Fasting Glucose Baseline, Week 72 Mean Percent Change from Baseline in Fasting Insulin Baseline, Week 72 Mean Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 72 Mean Change from Baseline in Short Form Version 2 (SF-36v2) Acute Form Domain Scores Baseline, Week 72
Trial Locations
- Locations (138)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, Arizona, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
🇺🇸Sun City West, Arizona, United States
John Muir Physician Network Research Center
🇺🇸Concord, California, United States
AMCR Institute
🇺🇸Escondido, California, United States
NorCal Medical Research, Inc
🇺🇸Greenbrae, California, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Norcal Endocrinology & Internal Medicine
🇺🇸San Ramon, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
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