A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

NCTNCT06143956Other id18685Other idW8M-MC-CWMMOther idW8M-MC-OXA1Other idW8M-MC-LAA1

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Overview

Status: Recruiting
Phase: Phase 2
Enrollment: 1,481 participants (estimated)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 2 countries
United States, Argentina
Start: 17 Nov 2023
Primary completion: Sept 2027 (estimated)
Completion: Feb 2028 (estimated)
First posted: 22 Nov 2023
Last update posted: 7 Oct 2026
Conditions: Obesity · Overweight

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026202720282029

Ph 2
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
NCT06143956
17 Nov 2023 to est. Feb 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

Interventions

LY3305677Drug
LY3841136Drug
TirzepatideDrug
LY3549492Drug
LY3532226Drug
PlaceboDrug
PlaceboDrug

Arms6

Experimental
LY3305677 Obesity ISA OXA1
Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.
Experimental
LY3841136 Obesity ISA LAA1
Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.
Experimental
LY3841136 Obesity ISA LAA2
Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.
Experimental
LY3549492 Obesity ISA GN01
Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
Experimental
LY3549492 Obesity ISA GN02
Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
Experimental
Obesity ISA MC01
Participants will receive macupatide, eloralintide, and placebo SC. Each ISA will detail the intervention specific analysis.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants Allocated to Each ISA
Time frame · Baseline to Week 6
Registry description
Each ISA will detail the intervention specific analysis.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Have a body mass index (BMI) * ≥30 kilogram/square meter (kg/m²), or * ≥27 kg/m² and \<30 kg/m², or with at least 1 weight-related comorbidity * Have had a stable body weight for the 3 months prior to randomization (\<5%) body weight gain and/or loss. Exclusion Criteria: * Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening. * Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma. * Have poorly controlled hypertension. * Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease. * Have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure. * Have a history of symptomatic gallbladder disease within the past 2 years. * Have a lifetime history of suicide attempts.

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