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

NCT ID: NCT07215559

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-16

Study Completion Date

2027-05-31

Brief Summary

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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

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Conditions

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Obesity Overweight Diabetes Mellitus, Type 2

Keywords

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GIP Amylin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Macupatide (Macupatide + Eloralintide Placebo)

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

Group Type EXPERIMENTAL

Macupatide

Intervention Type DRUG

Administered SC

Eloralintide Placebo

Intervention Type DRUG

Administered SC

Eloralintide (Elorlintide + Macupatide Placebo)

Participants will be administered eloralintide SC and macupatide placebo SC

Group Type EXPERIMENTAL

Eloralintide

Intervention Type DRUG

Administered SC

Macupatide Placebo

Intervention Type DRUG

Administered SC

Macupatide + Eloralintide

Participants will be administered eloralintide SC and macupatide SC

Group Type EXPERIMENTAL

Macupatide

Intervention Type DRUG

Administered SC

Eloralintide

Intervention Type DRUG

Administered SC

Placebo (Macupatide Placebo + Elorlintide Placebo)

Participants will be administered eloralintide placebo SC and macupatide placebo SC

Group Type PLACEBO_COMPARATOR

Macupatide Placebo

Intervention Type DRUG

Administered SC

Eloralintide Placebo

Intervention Type DRUG

Administered SC

Interventions

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Macupatide

Administered SC

Intervention Type DRUG

Eloralintide

Administered SC

Intervention Type DRUG

Macupatide Placebo

Administered SC

Intervention Type DRUG

Eloralintide Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3532226 LY3841136

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC

Gilbert, Arizona, United States

Site Status RECRUITING

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Site Status RECRUITING

Pima Heart

Tucson, Arizona, United States

Site Status RECRUITING

SKY Clinical Research Network Group-Brown

Atlanta, Georgia, United States

Site Status RECRUITING

Teak Research Consults

Lawrenceville, Georgia, United States

Site Status RECRUITING

AGILE Clinical Research Trials, LLC

Sandy Springs, Georgia, United States

Site Status RECRUITING

Pivotal Research Solutions

Stonecrest, Georgia, United States

Site Status RECRUITING

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Site Status RECRUITING

Vector Clinical Trials

Las Vegas, Nevada, United States

Site Status RECRUITING

Premier Research

Trenton, New Jersey, United States

Site Status RECRUITING

Mercy Family Clinic

Dallas, Texas, United States

Site Status RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status RECRUITING

PlanIt Research, PLLC

Houston, Texas, United States

Site Status RECRUITING

Aavon Clinical Trials

Richmond, Texas, United States

Site Status RECRUITING

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status RECRUITING

Texas Valley Clinical Research

Weslaco, Texas, United States

Site Status NOT_YET_RECRUITING

Kalo Clinical Research

West Valley City, Utah, United States

Site Status RECRUITING

Eastern Virginia Medical School (EVMS) Medical Group

Norfolk, Virginia, United States

Site Status NOT_YET_RECRUITING

Clinical Research Partners, LLC

Richmond, Virginia, United States

Site Status RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status RECRUITING

Rainier Clinical Research Center

Renton, Washington, United States

Site Status RECRUITING

Universal Research Group

Tacoma, Washington, United States

Site Status RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

CENUDIAB

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

CEDIC

CABA, , Argentina

Site Status NOT_YET_RECRUITING

Instituto de Investigaciones Clínicas Córdoba

Córdoba, , Argentina

Site Status NOT_YET_RECRUITING

Clínica Universitaria Reina Fabiola

Córdoba, , Argentina

Site Status NOT_YET_RECRUITING

Go Centro Medico San Nicolás

San Nicolás, , Argentina

Site Status NOT_YET_RECRUITING

Emeritus Research

Botany, , Australia

Site Status RECRUITING

Core Research Group

Brisbane, , Australia

Site Status RECRUITING

Emeritus Research

Camberwell, , Australia

Site Status RECRUITING

Cornerstone Dermatology

Coorparoo, , Australia

Site Status RECRUITING

Momentum Darlinghurst

Darlinghurst, Sydney, , Australia

Site Status RECRUITING

CDH Research Institute Pty Ltd

Maroochydore, , Australia

Site Status RECRUITING

Momentum Sunshine

Melbourne, , Australia

Site Status RECRUITING

AIM Research

Merewether, , Australia

Site Status RECRUITING

San Juan Bautista School of Medicine - Clinical Research Unit

Caguas, , Puerto Rico

Site Status RECRUITING

Mgcendo Llc

San Juan, , Puerto Rico

Site Status RECRUITING

Countries

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United States Argentina Australia Puerto Rico

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Role: primary

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Related Links

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https://trials.lilly.com/en-US/trial/659876

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

Other Identifiers

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J2V-MC-GZLF

Identifier Type: OTHER

Identifier Source: secondary_id

27721

Identifier Type: -

Identifier Source: org_study_id