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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • See Master Protocol CWMM (NCT06143956) for inclusion criteria

Exclusion Criteria

In addition to exclusion criteria in Master Protocol CWMM (NCT06143956): - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Macupatide Dose 1 		Participants will receive macupatide subcutaneously (SC)
  • Drug: Macupatide
    Administered SC
    Other names:
    • LY3532226
Experimental
Eloralintide Dose 1 		Participants will receive eloralintide SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Experimental
Macupatide Dose 1 + Eloralintide Dose 1 		Participants will receive macupatide SC and eloralintide SC
  • Drug: Macupatide
    Administered SC
    Other names:
    • LY3532226
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Experimental
Eloralintide Dose 2 		Participants will receive eloralintide SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Experimental
Macupatide Dose 1 + Eloralintide Dose 2 		Participants will receive macupatide SC and eloralintide SC
  • Drug: Macupatide
    Administered SC
    Other names:
    • LY3532226
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Experimental
Eloralintide Dose 3 		Participants will receive eloralintide SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Experimental
Macupatide Dose 2 + Eloralintide Dose 3 		Participants will receive macupatide SC and eloralintide SC
  • Drug: Macupatide
    Administered SC
    Other names:
    • LY3532226
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Placebo Comparator
Placebo 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona 85225

Headlands Research - Scottsdale
Scottsdale, Arizona 85260

The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona 85712

NorCal Medical Research, Inc
Greenbrae, California 94904

Velocity Clinical Research, Huntington Park
Huntington Park, California 90255

Peninsula Research Associates
Rolling Hills Estates, California 90274

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Stamford Therapeutics Consortium
Stamford, Connecticut 06905

New Horizon Research Center
Miami, Florida 33165

Indago Research & Health Center, Inc
Miami Lakes, Florida 33016

Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652

Charter Research - Winter Park
Orlando, Florida 32803

Charter Research - Lady Lake
The Villages, Florida 32162

Medical Research Partners
Ammon, Idaho 83406

Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640

Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas 66606

Monroe Biomedical Research - Louisville
Louisville, Kentucky 40213

Knownwell
Needham, Massachusetts 02492

Lucida Clinical Trials
New Bedford, Massachusetts 02740

Headlands Research - Detroit
Southfield, Michigan 48034

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098

StudyMetrix Research
City of Saint Peters, Missouri 63303

Clinvest Headlands Llc
Springfield, Missouri 65807

Las Vegas Medical Research
Las Vegas, Nevada 89128

Dent Neurologic Institute
Amherst, New York 14226

Rochester Clinical Research, LLC
Rochester, New York 14609

Medication Management
Greensboro, North Carolina 27405

Monroe Biomedical Research
Monroe, North Carolina 28112

Lucas Research, Inc
Morehead City, North Carolina 28557

Lucas Research, Inc.
New Bern, North Carolina 28562

CTI Clinical Research Center
Cincinnati, Ohio 45212

Tribe Clinical Research, LLC
Greenville, South Carolina 29607

Quality Medical Research
Nashville, Tennessee 37211

IMA Clinical Research Austin
Austin, Texas 78745

FutureSearch Trials of Dallas
Dallas, Texas 75251

PlanIt Research, PLLC
Houston, Texas 77079

Endeavor Clinical Trials
San Antonio, Texas 78240

Texas Valley Clinical Research
Weslaco, Texas 78596

Sovah Clinical Research-River District
Danville, Virginia 24541

Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington 98801

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.