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 (ACHIEVE-4)
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.
clinicaltrials.govEligibility
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