Condition: Type 2 Diabetes · Obesity · Overweight or Obesity · Sponsor: Eli Lilly and Company
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Alliance for Multispecialty Research, LLC | Daphne, Alabama, United States | — |
| Alliance for Multispecialty Research, LLC | Mobile, Alabama, United States | — |
| Cahaba Research - Pelham | Pelham, Alabama, United States | — |
| Syed Research Consultants Llc | Sheffield, Alabama, United States | — |
| The Institute for Liver Health | Chandler, Arizona, United States | — |
| Aventiv Research | Mesa, Arizona, United States | — |
| Arizona Liver Health - Peoria | Peoria, Arizona, United States | — |
| Elite Clinical Studies, LLC | Phoenix, Arizona, United States | — |
| Absolute Clinical Research | Phoenix, Arizona, United States | — |
| Clinical Research Institute of Arizona (CRI) - Sun City West | Sun City West, Arizona, United States | — |
| Alliance for Multispecialty Research, LLC | Tempe, Arizona, United States | — |
| Orange Grove Family Practice | Tucson, Arizona, United States | — |
+ 346 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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