A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2025-06-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.

This study includes 3 periods as follows:

• screening and lead-in period: up to 4 weeks

• treatment period: 52 weeks, including 20 weeks of dose escalation, and

• safety follow-up period: 2 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Have Type 2 Diabetes (T2D)

• Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening.

• Are of stable 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.

• Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria:

• Have Type 1 Diabetes (T1D).

• Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.

• Have New York Heart Association functional classification IV congestive heart failure.

• Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.

• acute myocardial infarction

• cerebrovascular accident (stroke), or

• hospitalization for congestive heart failure

• Have acute or chronic hepatitis and pancreatitis