NCT07215559

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
12mo left

Started Oct 2025

Geographic Reach
4 countries

38 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Oct 2025May 2027

First Submitted

Initial submission to the registry

October 9, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

October 16, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

October 9, 2025

Last Update Submit

February 27, 2026

Conditions

Keywords

GIPAmylin

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Body Weight

    Baseline, Week 32

Secondary Outcomes (3)

  • 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

Study Arms (4)

Macupatide (Macupatide + Eloralintide Placebo)

EXPERIMENTAL

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

Drug: MacupatideDrug: Eloralintide Placebo

Eloralintide (Elorlintide + Macupatide Placebo)

EXPERIMENTAL

Participants will be administered eloralintide SC and macupatide placebo SC

Drug: EloralintideDrug: Macupatide Placebo

Macupatide + Eloralintide

EXPERIMENTAL

Participants will be administered eloralintide SC and macupatide SC

Drug: MacupatideDrug: Eloralintide

Placebo (Macupatide Placebo + Elorlintide Placebo)

PLACEBO COMPARATOR

Participants will be administered eloralintide placebo SC and macupatide placebo SC

Drug: Macupatide PlaceboDrug: Eloralintide Placebo

Interventions

Administered SC

Also known as: LY3841136
Eloralintide (Elorlintide + Macupatide Placebo)Macupatide + Eloralintide

Administered SC

Eloralintide (Elorlintide + Macupatide Placebo)Placebo (Macupatide Placebo + Elorlintide Placebo)

Administered SC

Also known as: LY3532226
Macupatide (Macupatide + Eloralintide Placebo)Macupatide + Eloralintide

Administered SC

Macupatide (Macupatide + Eloralintide Placebo)Placebo (Macupatide Placebo + Elorlintide Placebo)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

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

Gilbert, Arizona, 85296, United States

RECRUITING

Synexus Clinical Research US, Inc.

Phoenix, Arizona, 85020, United States

RECRUITING

Pima Heart

Tucson, Arizona, 85741, United States

RECRUITING

SKY Clinical Research Network Group-Brown

Atlanta, Georgia, 30331, United States

RECRUITING

Teak Research Consults

Lawrenceville, Georgia, 30043, United States

RECRUITING

AGILE Clinical Research Trials, LLC

Sandy Springs, Georgia, 30328, United States

RECRUITING

Pivotal Research Solutions

Stonecrest, Georgia, 30038, United States

RECRUITING

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

RECRUITING

Vector Clinical Trials

Las Vegas, Nevada, 89128, United States

RECRUITING

Premier Research

Trenton, New Jersey, 08611, United States

RECRUITING

Mercy Family Clinic

Dallas, Texas, 75208, United States

RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

RECRUITING

PlanIt Research, PLLC

Houston, Texas, 77079, United States

RECRUITING

Aavon Clinical Trials

Richmond, Texas, 77407, United States

RECRUITING

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

RECRUITING

Texas Valley Clinical Research

Weslaco, Texas, 78596, United States

RECRUITING

Kalo Clinical Research

West Valley City, Utah, 84120, United States

RECRUITING

Eastern Virginia Medical School (EVMS) Medical Group

Norfolk, Virginia, 23510, United States

RECRUITING

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Rainier Clinical Research Center

Renton, Washington, 98057, United States

RECRUITING

Universal Research Group

Tacoma, Washington, 98405, United States

RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI, Argentina

RECRUITING

CENUDIAB

Buenos Aires, C1440AAD, Argentina

RECRUITING

CEDIC

CABA, C1060ABN, Argentina

RECRUITING

Instituto de Investigaciones Clínicas Córdoba

Córdoba, 5000, Argentina

RECRUITING

Clínica Universitaria Reina Fabiola

Córdoba, X50004FHP, Argentina

RECRUITING

Go Centro Medico San Nicolás

San Nicolás, 2900, Argentina

RECRUITING

Emeritus Research

Botany, 2019, Australia

RECRUITING

Core Research Group

Brisbane, 4064, Australia

RECRUITING

Emeritus Research

Camberwell, 3124, Australia

RECRUITING

Cornerstone Dermatology

Coorparoo, 4151, Australia

RECRUITING

Momentum Darlinghurst

Darlinghurst, Sydney, 2010, Australia

RECRUITING

CDH Research Institute Pty Ltd

Maroochydore, 4558, Australia

RECRUITING

Momentum Sunshine

Melbourne, 3021, Australia

RECRUITING

AIM Research

Merewether, 2291, Australia

RECRUITING

San Juan Bautista School of Medicine - Clinical Research Unit

Caguas, 00726, Puerto Rico

RECRUITING

Mgcendo Llc

San Juan, 00921, Puerto Rico

RECRUITING

Related Links

MeSH Terms

Conditions

ObesityOverweightDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

Physicians interested in becoming principal investigators please contact

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2025

First Posted

October 10, 2025

Study Start

October 16, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations