A Phase 3, Open-Label Study of Once Daily LY3502970 Compared with Insulin Glargine in Adult Participants with Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk (ACHIEVE-4) - NI

Eli Lilly and Company India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•1. Have been diagnosed with type 2 diabetes mellitus (T2DM)
•2. 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.
•3. Have HbA1c at screening of =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.
•4. 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
•5. 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
•6. Are of stable weight (± 5%) for at least 90 days prior to screening
•7. Have a BMI =25 kilograms per meter squared (kg/m2) at screening

•1. Have type 1 diabetes mellitus
•2. Have had chronic or acute pancreatitis any time prior to screening
•3. 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
•4. Have a known clinically significant gastric emptying abnormality
•5. 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
•6. Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure
•7. Have an eGFR <15 mL/min/1.73 m2 as determined at screening
•8. Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
•9. Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days
•10. Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening

发起方

Eli Lilly and Company India Pvt Ltd