A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

Key facts

Study ID

NCT06109311

Run by

Eli Lilly and Company

People needed

546

Starts

2023-11-10

Expected to finish

2025-09-15

Last updated by the study team

2025-10-20

Who can join

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

You may qualify if…

• Have Type 2 Diabetes (T2D)
• Have HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]
• Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:
• insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
• insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
• metformin, or
• SGLT-2 inhibitor, or
• both metformin and SGLT-2 inhibitor.
• Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 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.
• Have a Body Mass Index (BMI) ≥23.0 kg/m\^2 at baseline.

You may not qualify if…

• Have New York Heart Association functional classification III-IV congestive heart failure.
• Have had any of the following cardiovascular conditions within 60 days prior to baseline.
• acute myocardial infarction
• cerebrovascular accident (stroke), or
• hospitalization for congestive heart failure.
• Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
• Have had chronic or acute pancreatitis any time.

Where it is running

• Phoenix Clinical LLC — Phoenix, Arizona, United States
• SanRo Clinical Research Group — Bryant, Arkansas, United States
• Velocity Clinical Research, Gardena — Gardena, California, United States
• Loma Linda University Health System — Loma Linda, California, United States
• Western University of Health Sciences — Pomona, California, United States
• Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. — Toluca Lake, California, United States
• CMR of Greater New Haven, LLC — Hamden, Connecticut, United States
• Care Access - Brandon — Brandon, Florida, United States
• Encore Medical Research — Hollywood, Florida, United States
• Encore Medical Research - Weston — Weston, Florida, United States
• Orita Clinical Research — Decatur, Georgia, United States
• Bingham Memorial Hospital — Blackfoot, Idaho, United States
• St. Luke's Humphreys Diabetes Center: Boise — Boise, Idaho, United States
• Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States
• The Research Group of Lexington — Lexington, Kentucky, United States
• Clinvest Headlands Llc — Springfield, Missouri, United States
• Richmond University Medical Center — Staten Island, New York, United States
• Velocity Clinical Research, Mt. Auburn — Cincinnati, Ohio, United States
• Velocity Clinical Research, Medford — Medford, Oregon, United States
• Tristar Clinical Investigations — Philadelphia, Pennsylvania, United States
• Frontier Clinical Research, LLC — Scottdale, Pennsylvania, United States
• Lifedoc Research - Lenox Park Drive — Memphis, Tennessee, United States
• Consano Clinical Research, LLC — Shavano Park, Texas, United States
• Texas Valley Clinical Research — Weslaco, Texas, United States
• MD First Research - Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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