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

Phase 2RecruitingNCT07589608

Eli Lilly and Company400 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Overweight Obesity

Interventions

MacupatideDRUG

Administered SC

EloralintideDRUG

Administered SC

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (40)

Outcomes

Primary Outcomes

Percent Change from Baseline in Body Weight

Time frame: Baseline, Week 36

Secondary Outcomes

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

Central Contacts

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

CONTACT

317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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