A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

• Status: Not yet recruiting
• Trial end date: 2025-09-24
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin Glargine

Criteria

Inclusion Criteria:

• Have been diagnosed with type 2 diabetes mellitus (T2DM)

• Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.

• Have HbA1c at screening

• ≥7.0% and ≤10.5% if background diabetes medication does not include a sulfonylurea, or

• ≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.

• Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas

• Have increased risk for cardiovascular (CV) events due to:

• Coronary heart disease

• Peripheral arterial disease, presumed to be of atherosclerotic origin

• Cerebrovascular disease, presumed to be of atherosclerotic origin

• Chronic kidney disease (CKD)

• Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III

• Are of stable weight (± 5%) for at least 90 days prior to screening

• Have a BMI ≥27 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

• Have type 1 diabetes mellitus

• Have had chronic or acute pancreatitis any time prior to screening

• Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors

• Have a known clinically significant gastric emptying abnormality

• Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level ≥5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory

• Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure

• Have an eGFR <15 mL/min/1.73 m2 as determined at screening

• Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

• Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days

• Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening