A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes
Phase 2 – studying effectiveness and dosage
Conditions:
Obesity
Overweight
Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
trial.available_in:
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Overview
The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.
Who can participate
Inclusion Criteria:
* Have type 2 diabetes
* Have an HbA1c ≥7.5% to ≤10.5% at screening
* Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening
* Diet and exercise
* Stable dose of metformin
* Sodium-glucose cotransporter-2 (SGLT2) inhibitor
* Have had a stable body weight (\<5% body weight gain and/or loss) for the 3 months prior to screening
* Have a BMI of 27 or greater at screening
Exclusion Criteria:
* Have any form of diabetes other than type 2 diabetes
* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening
* Have any of the following cardiovascular conditions within 3 months prior to screening:
* acute myocardial infarction
* cerebrovascular accident (stroke)
* unstable angina, or
* hospitalization due to congestive heart failure
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include
* basal or squamous cell skin cancer
* in situ carcinomas of the cervix, or
* in situ prostate cancer
* Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:
* amylin RA
* dual amylin and calcitonin RA
* glucagon-like peptide-1 receptor (GLP-1) RA
* glucose-dependent insulinotropic peptide (GIP)/GLP-1 RA
* GLP-1/glucagon (GCG) RAs, or
* GIP/GLP-1/GCG RAs
* Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides
* Have used insulin for diabetic control within the prior year (short term use in certain situations allowed