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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Overweight; Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Macupatide; Drug: Macupatide Placebo; Drug: Eloralintide; Drug: Eloralintide Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07215559

27721

J2V-MC-GZLF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups, including a placebo group

Macupatide (Macupatide + Eloralintide Placebo)

Experimental group

Description:

Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC

Treatment:

Drug: Eloralintide Placebo

Drug: Macupatide

Eloralintide (Elorlintide + Macupatide Placebo)

Experimental group

Description:

Participants will be administered eloralintide SC and macupatide placebo SC

Treatment:

Drug: Eloralintide

Drug: Macupatide Placebo

Macupatide + Eloralintide

Experimental group

Description:

Participants will be administered eloralintide SC and macupatide SC

Treatment:

Drug: Eloralintide

Drug: Macupatide

Placebo (Macupatide Placebo + Elorlintide Placebo)

Placebo Comparator group

Description:

Participants will be administered eloralintide placebo SC and macupatide placebo SC

Treatment:

Drug: Eloralintide Placebo

Drug: Macupatide Placebo