A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Macupatide, Eloralintide, Placebo.
- Who it may be relevant to
- Registry conditions: Overweight, Obesity. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Macupatide
Administered SC - Drug Eloralintide
Administered SC - Drug Placebo
Administered SC
Primary outcome measures
- Percent Change from Baseline in Body Weight [Time frame: Baseline, Week 36]
Secondary outcome measures (5)
- Percent Change from Baseline in Body Weight [Time frame: Baseline, Week 48]
- Change from Baseline in Body Weight [Time frame: Baseline, Week 36]
- Percentage of Participants who Achieve ≥5% Body Weight Reduction [Time frame: Week 36]
- Percentage of Participants who Achieve ≥10% Body Weight Reduction [Time frame: Week 36]
- Change from Baseline in Body Mass Index (BMI) [Time frame: Baseline, Week 36]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 40 centers
- The Institute for Liver Health II dba Arizona Clinical Trials - Mesa — Chandler
- Headlands Research - Scottsdale — Scottsdale
- The Institute for Liver Health II dba Arizona Liver Health-Tucson — Tucson
- NorCal Medical Research, Inc — Greenbrae
- Velocity Clinical Research, Huntington Park — Huntington Park
- Peninsula Research Associates — Rolling Hills Estates
- Diablo Clinical Research, Inc. — Walnut Creek
- Stamford Therapeutics Consortium — Stamford
- … and 32 more centers
Identifiers
NCT: NCT07589608 · 27844 · W8M-MC-MC01 · W8M-MC-CWMM