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

Not Applicable

Not yet recruiting

• Conditions: Obesity; Overweight; Diabetes Mellitus, Type 2
• Interventions: Drug: Macupatide; Drug: Eloralintide; Drug: Eloralintide Placebo; Drug: Macupatide Placebo

• Registration Number: NCT07215559
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-09
• Study First Submitted QC: 2025-10-09
• Last Update Submitted: 2025-10-09
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10
• Study Start: 2025-11-01
• Primary Completion: 2027-03
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macupatide (Macupatide + Eloralintide Placebo)	Macupatide	Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC
Macupatide (Macupatide + Eloralintide Placebo)	Eloralintide Placebo	Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC
Eloralintide (Elorlintide + Macupatide Placebo)	Eloralintide	Participants will be administered eloralintide SC and macupatide placebo SC
Eloralintide (Elorlintide + Macupatide Placebo)	Macupatide Placebo	Participants will be administered eloralintide SC and macupatide placebo SC
Macupatide + Eloralintide	Macupatide	Participants will be administered eloralintide SC and macupatide SC
Macupatide + Eloralintide	Eloralintide	Participants will be administered eloralintide SC and macupatide SC
Placebo (Macupatide Placebo + Elorlintide Placebo)	Macupatide Placebo	Participants will be administered eloralintide placebo SC and macupatide placebo SC
Placebo (Macupatide Placebo + Elorlintide Placebo)	Eloralintide Placebo	Participants will be administered eloralintide placebo SC and macupatide placebo SC

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline, Week 32

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 32
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 32
Change from Baseline in Fasting Glucose	Baseline, Week 32

Trial Locations

Locations (37)

Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC; 🇺🇸 Gilbert, Arizona, United States

Central Phoenix Medical Clinic; 🇺🇸 Phoenix, Arizona, United States

Pima Heart; 🇺🇸 Tucson, Arizona, United States

SKY Clinical Research Network Group-Brown; 🇺🇸 Atlanta, Georgia, United States

Teak Research Consults; 🇺🇸 Lawrenceville, Georgia, United States

AGILE Clinical Research Trials, LLC; 🇺🇸 Sandy Springs, Georgia, United States

Pivotal Research Solutions; 🇺🇸 Stonecrest, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG; 🇺🇸 Union City, Georgia, United States

Vector Clinical Trials; 🇺🇸 Las Vegas, Nevada, United States

Premier Research; 🇺🇸 Trenton, New Jersey, United States

Scroll for more (27 remaining)