NCT07589608

Brief Summary

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
20mo left

Started Jun 2026

Geographic Reach
1 country

40 active sites

Status
not yet 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

First Submitted

Initial submission to the registry

May 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Body Weight

    Baseline, Week 36

Secondary Outcomes (5)

  • Percent Change from Baseline in Body Weight

    Baseline, Week 48

  • Change from Baseline in Body Weight

    Baseline, Week 36

  • Percentage of Participants who Achieve ≥5% Body Weight Reduction

    Week 36

  • Percentage of Participants who Achieve ≥10% Body Weight Reduction

    Week 36

  • Change from Baseline in Body Mass Index (BMI)

    Baseline, Week 36

Study Arms (8)

Macupatide Dose 1

EXPERIMENTAL

Participants will receive macupatide subcutaneously (SC)

Drug: Macupatide

Eloralintide Dose 1

EXPERIMENTAL

Participants will receive eloralintide SC

Drug: Eloralintide

Macupatide Dose 1 + Eloralintide Dose 1

EXPERIMENTAL

Participants will receive macupatide SC and eloralintide SC

Drug: MacupatideDrug: Eloralintide

Eloralintide Dose 2

EXPERIMENTAL

Participants will receive eloralintide SC

Drug: Eloralintide

Macupatide Dose 1 + Eloralintide Dose 2

EXPERIMENTAL

Participants will receive macupatide SC and eloralintide SC

Drug: MacupatideDrug: Eloralintide

Eloralintide Dose 3

EXPERIMENTAL

Participants will receive eloralintide SC

Drug: Eloralintide

Macupatide Dose 2 + Eloralintide Dose 3

EXPERIMENTAL

Participants will receive macupatide SC and eloralintide SC

Drug: MacupatideDrug: Eloralintide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC

Drug: Placebo

Interventions

Administered SC

Also known as: LY3532226
Macupatide Dose 1Macupatide Dose 1 + Eloralintide Dose 1Macupatide Dose 1 + Eloralintide Dose 2Macupatide Dose 2 + Eloralintide Dose 3

Administered SC

Also known as: LY3841136
Eloralintide Dose 1Eloralintide Dose 2Eloralintide Dose 3Macupatide Dose 1 + Eloralintide Dose 1Macupatide Dose 1 + Eloralintide Dose 2Macupatide Dose 2 + Eloralintide Dose 3

Administered SC

Placebo

Eligibility Criteria

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

You may not qualify if:

  • Have type 1 diabetes or type 2 diabetes
  • Have an ongoing history of bradyarrhythmia and/or sinus bradycardia
  • Have an elevated resting pulse rate (greater than 100 bpm) or reduced resting pulse rate (less than 60 bpm)
  • Have a history of acute or chronic pancreatitis
  • All concomitant medications should be at a stable dose for at least 3 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

Chandler, Arizona, 85225, United States

Location

Headlands Research - Scottsdale

Scottsdale, Arizona, 85260, United States

Location

The Institute for Liver Health II dba Arizona Liver Health-Tucson

Tucson, Arizona, 85712, United States

Location

NorCal Medical Research, Inc

Greenbrae, California, 94904, United States

Location

Velocity Clinical Research, Huntington Park

Huntington Park, California, 90255, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Charter Research - Winter Park

Orlando, Florida, 32803, United States

Location

Charter Research - Lady Lake

The Villages, Florida, 32162, United States

Location

Medical Research Partners

Ammon, Idaho, 83406, United States

Location

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, 60640, United States

Location

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, 66606, United States

Location

Monroe Biomedical Research - Louisville

Louisville, Kentucky, 40213, United States

Location

Knownwell

Needham, Massachusetts, 02492, United States

Location

Lucida Clinical Trials

New Bedford, Massachusetts, 02740, United States

Location

Headlands Research - Detroit

Southfield, Michigan, 48034, United States

Location

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, 48098, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Headlands Llc

Springfield, Missouri, 65807, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89128, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

Medication Management

Greensboro, North Carolina, 27405, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Lucas Research, Inc

Morehead City, North Carolina, 28557, United States

Location

Lucas Research, Inc.

New Bern, North Carolina, 28562, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

Location

Quality Medical Research

Nashville, Tennessee, 37211, United States

Location

IMA Clinical Research Austin

Austin, Texas, 78745, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75251, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

Texas Valley Clinical Research

Weslaco, Texas, 78596, United States

Location

Sovah Clinical Research-River District

Danville, Virginia, 24541, United States

Location

Central Washington Health Services Association d/b/a Confluence Health

Wenatchee, Washington, 98801, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

May 11, 2026

First Posted

May 15, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

May 15, 2026

Record last verified: 2026-05

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