A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.

Key facts

Study ID

NCT06045221

Run by

Eli Lilly and Company

People needed

1698

Starts

2023-09-22

Expected to finish

2025-08-22

Last updated by the study team

2025-09-22

Who can join

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

You may qualify if…

• Have Type 2 Diabetes
• Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening.
• Have been on stable diabetes treatment with metformin ≥1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization.
• Are of stable body weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment

You may not qualify if…

• Have Type 1 Diabetes
• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors.
• Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
• Have a New York Heart Association functional classification IV congestive heart failure.
• Have an estimated glomerular filtration rate (eGFR) <45 milliliter/minute (mL/min)/1.73 square meter (m²) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening.
• Have a serum calcitonin level of ≥35 nanogram/Liter (ng/L), as determined by the central laboratory at screening.
• Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.

Where it is running

• San Fernando Valley Health Institute — Canoga Park, California, United States
• Neighborhood Healthcare Institute of Health — Escondido, California, United States
• Velocity Clinical Research, Gardena — Gardena, California, United States
• Biopharma Informatic, LLC — Los Angeles, California, United States
• Velocity Clinical Research, Westlake — Los Angeles, California, United States
• Infinity Clinical Research - Norco — Norco, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Norcal Endocrinology & Internal Medicine — San Ramon, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• New West Physicians Clinical Research — Golden, Colorado, United States
• Connecticut Clinical Research - Cromwell — Cromwell, Connecticut, United States
• Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States
• South Florida Clinical Research Institute — Margate, Florida, United States
• Miami Dade Medical Research Institute, LLC — Miami, Florida, United States
• West Orange Endocrinology — Ocoee, Florida, United States
• Latin Clinical Trial Center Florida — Tamarac, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Balanced Life Health Care Solutions/SKYCRNG — Lawrenceville, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• North Georgia Clinical Research — Woodstock, Georgia, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Family First Medical Center — Idaho Falls, Idaho, United States
• Absolute Clinical Research — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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