A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight

NCT07589608
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
400
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Lead sponsor
Eli Lilly and Company
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Start date
2026-05-15
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Number of sites
40
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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.
clinicaltrials.gov
Short title
A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight
clinicaltrials.gov
Official title
A Phase 2b, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and Without Type 2 Diabetes
clinicaltrials.gov

Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-02-01
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First posted
2026-05-15
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Registry last updated
2026-08-06
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Primary completion date
2027-09-01
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Start date
2026-05-15
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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Protocol amendments
0
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Number of sites
40
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07589608
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ClinicalTrials.gov ID
NCT07589608
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent Change from Baseline in Body Weight

    Timeframe: Baseline, Week 36

  1. Percent Change from Baseline in Body Weight

    Timeframe: Baseline, Week 48

  2. Change from Baseline in Body Weight

    Timeframe: Baseline, Week 36

  3. Percentage of Participants who Achieve ≥5% Body Weight Reduction

    Timeframe: Week 36

  4. Percentage of Participants who Achieve ≥10% Body Weight Reduction

    Timeframe: Week 36

  5. Change from Baseline in Body Mass Index (BMI)

    Timeframe: Baseline, Week 36

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • See Master Protocol CWMM (NCT06143956) for inclusion 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
Sources for eligibility
clinicaltrials.gov

  • The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandler, United StatesRecruiting
  • Headlands Research - ScottsdaleScottsdale, United StatesRecruiting
  • The Institute for Liver Health II dba Arizona Liver Health-TucsonTucson, United StatesRecruiting
  • NorCal Medical Research, IncGreenbrae, United StatesRecruiting
  • Velocity Clinical Research, Huntington ParkHuntington Park, United StatesRecruiting
  • Peninsula Research AssociatesRolling Hills Estates, United StatesRecruiting
  • Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting
  • Stamford Therapeutics ConsortiumStamford, United StatesRecruiting
  • New Horizon Research CenterMiami, United StatesRecruiting
  • Indago Research & Health Center, IncMiami Lakes, United StatesRecruiting
  • Suncoast Clinical Research, Inc.New Port Richey, United StatesRecruiting
  • Charter Research - Winter ParkOrlando, United StatesRecruiting
  • Charter Research - Lady LakeThe Villages, United StatesRecruiting
  • Medical Research PartnersAmmon, United StatesRecruiting
  • Great Lakes Clinical Trials - RavenswoodChicago, United StatesRecruiting
  • Cotton O'Neil Diabetes & EndocrinologyTopeka, United StatesRecruiting
  • Monroe Biomedical Research - LouisvilleLouisville, United StatesRecruiting
  • KnownwellNeedham, United StatesRecruiting
  • Lucida Clinical TrialsNew Bedford, United StatesRecruiting
  • Headlands Research - DetroitSouthfield, United StatesRecruiting
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United StatesRecruiting
  • StudyMetrix ResearchCity of Saint Peters, United StatesRecruiting
  • Clinvest Headlands LlcSpringfield, United StatesRecruiting
  • Las Vegas Medical ResearchLas Vegas, United StatesRecruiting
  • Dent Neurologic InstituteAmherst, United StatesRecruiting

And 15 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • W8M-MC-MC01
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)