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)

<p>Inclusion Criteria:</p><ul><li>Have been diagnosed with type 2 diabetes mellitus (T2DM)</li><li>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.</li></ul><p>Have HbA1c at screening</p><ul><li>≥7.0% and ≤0.5% if background diabetes medication does not include a sulfonylurea, or</li><li>≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.</li><li>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</li></ul><p>Have increased risk for cardiovascular (CV) events due to:</p><ul><li>Coronary heart disease</li><li>Peripheral arterial disease, presumed to be of atherosclerotic origin</li><li>Cerebrovascular disease, presumed to be of atherosclerotic origin</li><li>Chronic kidney disease (CKD)</li><li>Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III</li><li>Are of stable weight (± 5%) for at least 90 days prior to screening</li><li>Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening</li></ul>

<p>Exclusion Criteria:</p><ul><li>Have type 1 diabetes mellitus</li><li>Have had chronic or acute pancreatitis any time prior to screening</li><li>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</li><li>Have a known clinically significant gastric emptying abnormality</li><li>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</li><li>Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure</li><li>Have an eGFR &lt;15 mL/min/1.73 m2 as determined at screening</li><li>Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2</li><li>Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days</li><li>Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening</li></ul>