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
- CompletedResults none
- Why it is watched
- non-weight indication: cardiovascular, cerebrovascular, kidney
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥25 required; conditions: Type 2 Diabetes; Obesity; Overweight or Obesity; Overweight
- Interventions
- Orforglipron; Insulin Glargine
- Conditions
- Type 2 Diabetes; Obesity; Overweight or Obesity; Overweight; Cardiovascular Diseases; Chronic Kidney Disease
- Phase and size
- Phase 3 · 2749 participants
- Dates
- Start 2023-04-03
Primary completion 2026-03-16 - Sponsor
- Eli Lilly and Company (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]Baseline to End of the Study (Approximate Maximum 104 Weeks)
02Eligibility
Who can take part
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 ≥25 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
03Change log
Registry changes
No changes recorded since the trial was added.