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)

In by alicia.green

Locations
Macon
Condition
Diabetes, Obese/Obesity

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)

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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

clinicaltrials.gov

Eligibility

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
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