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Search / Trial NCT07215559

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

Launched by ELI LILLY AND COMPANY · Oct 9, 2025

Trial Information

Current as of October 29, 2025

Not yet recruiting

Keywords

Gip Amylin

ClinConnect Summary

This study is a Phase 2 clinical trial testing two drugs, macupatide and eloralintide, to see if they can help adults who are overweight or have obesity and also have type 2 diabetes lose weight. The study compares each drug alone, both drugs together, and a placebo (inactive treatment) in four groups. It’s designed so that participants and researchers don’t know who gets which treatment (double-blind), and participants are randomly assigned to a group. The main goal is to measure how much body weight changes from the start to about 32 weeks into the study. Researchers will also look at changes in a person’s long-term blood sugar (HbA1c), body mass index (BMI), and fasting blood glucose.

Eligible participants are adults aged 18 to 75 with type 2 diabetes and a body mass index (BMI) of 27 or higher, plus an HbA1c between 7.5% and 10.5% at screening. They should have been on stable diabetes management—such as diet and exercise, a stable metformin dose, or an SGLT2 inhibitor—for at least 3 months, and have had little weight change in the 3 months before screening. The trial isn’t recruiting yet (start planned for November 2025) and aims to enroll about 200 people at many sites in the United States, Argentina, Australia, Puerto Rico, and other locations. Participation is expected to last about 48 weeks, and the study is sponsored by Eli Lilly.

Gender

ALL

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

About Eli Lilly And Company

Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.

Locations

Renton, Washington, United States

Bellevue, Washington, United States

Trenton, New Jersey, United States

Tacoma, Washington, United States

Phoenix, Arizona, United States

Buenos Aires, Argentina

Richmond, Virginia, United States

Shavano Park, Texas, United States

Camberwell, Australia

Union City, Georgia, United States

Weslaco, Texas, United States

Stonecrest, Georgia, United States

Córdoba, Argentina

West Valley City, Utah, United States

Gilbert, Arizona, United States

Sandy Springs, Georgia, United States

Dallas, Texas, United States

San Juan, Puerto Rico

Córdoba, Argentina

Caguas, Puerto Rico

Houston, Texas, United States

Las Vegas, Nevada, United States

Norfolk, Virginia, United States

Tucson, Arizona, United States

Coorparoo, Australia

Botany, Australia

Caba, Argentina

Dallas, Texas, United States

Buenos Aires, Argentina

San Nicolás, Argentina

Brisbane, Australia

Merewether, Australia

Richmond, Texas, United States

Lawrenceville, Georgia, United States

Atlanta, Georgia, United States

Darlinghurst, Sydney, Australia

Maroochydore, Australia

Melbourne, Australia

Patients applied

0 patients applied

Trial Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Study Director

Eli Lilly and Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported