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A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes
A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes

NCT07215559

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Obesity, Overweight, Diabetes Mellitus, Type 2

Interventions: Macupatide, Eloralintide, Macupatide Placebo, Eloralintide Placebo

Countries: United States, Argentina, Australia, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (42)
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Sunrise, Florida, United States
  • Atlanta, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Sandy Springs, Georgia, United States
  • Stonecrest, Georgia, United States
  • Union City, Georgia, United States
  • Las Vegas, Nevada, United States
  • Trenton, New Jersey, United States
  • Dayton, Ohio, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Richmond, Texas, United States
  • Shavano Park, Texas, United States
  • Weslaco, Texas, United States
  • West Valley City, Utah, United States
  • Norfolk, Virginia, United States
  • Richmond, Virginia, United States
  • Bellevue, Washington, United States
  • Renton, Washington, United States
  • Tacoma, Washington, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • CABA, Argentina
  • Córdoba, Argentina
  • + 12 more on CT.gov