A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight, Type 2 Diabetes

In brief

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Key facts

Study ID

NCT05872620

Run by

Eli Lilly and Company

People needed

1613

Starts

2023-06-05

Expected to finish

2025-08-08

Last updated by the study team

2025-09-18

Who can join

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

You may qualify if…

• Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
• Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:
• either diet/exercise alone or
• up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

You may not qualify if…

• Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
• Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
• Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
• Have had a history of chronic or acute pancreatitis.

Where it is running

• Cahaba Research - Pelham — Pelham, Alabama, United States
• Novak Clinical Research - Tucson - North La Cholla Boulevard — Tucson, Arizona, United States
• Yuma Clinical Trials — Yuma, Arizona, United States
• AMCR Institute — Escondido, 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
• University Clinical Investigators, Inc. — Tustin, California, United States
• Encore Medical Research — Hollywood, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• South Florida Clinical Research Institute — Margate, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Balanced Life Health Care Solutions/SKYCRNG — Lawrenceville, Georgia, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• North Georgia Clinical Research — Woodstock, Georgia, United States
• Pacific Diabetes & Endocrine Center — Honolulu, Hawaii, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• MedStar Good Samaritan Hospital — Baltimore, Maryland, United States
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States
• StudyMetrix Research — City of Saint Peters, Missouri, United States
• Las Vegas Medical Research — Las Vegas, Nevada, United States
• IMA Clinical Research — Albuquerque, New Mexico, United States
• Albany Medical College, Division of Community Endocrinology — Albany, New York, United States
• Core Research Group — Brisbane, Queensland, Australia

Full record on ClinicalTrials.gov

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