A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight, Overweight or Obesity

In brief

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Key facts

Study ID

NCT05869903

Run by

Eli Lilly and Company

People needed

3127

Starts

2023-06-05

Expected to finish

2027-10-01

Last updated by the study team

2025-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• New Age Medical Research Corporation — Miami, Florida, United States
• South Broward Research — Miramar, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Jedidiah Clinical Research - Tampa - Bay Plaza — Tampa, Florida, United States
• Clinical Site Partners, LLC dba Flourish Research — Winter Park, Florida, United States
• Physicians Research Associates — Lawrenceville, Georgia, United States
• East Coast Institute for Research, LLC — Macon, Georgia, United States
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States
• Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Care Access - Lake Charles — Lake Charles, Louisiana, United States
• The Institute for Liver Health II dba Arizona Clinical Trials - Mesa — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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