A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) 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: LY3305677, LY3841136, Tirzepatide, LY3549492.
- Who it may be relevant to
- Registry conditions: Obesity, Overweight. 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, Argentina
- 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 Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight
Overview
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
- Drug LY3305677
Administered SC. ISA specific interventions will be listed in the ISA. - Drug LY3841136
Administered SC. ISA specific interventions will be listed in the ISA. - Drug Tirzepatide
Administered SC. ISA specific interventions will be listed in the ISA. - Drug LY3549492
Administered orally. ISA specific interventions will be listed in the ISA. - Drug LY3532226
Administered SC. ISA specific interventions will be listed in the ISA. - Drug Placebo
Administered SC. ISA specific interventions will be listed in the ISA. - Drug Placebo
Administered orally. ISA specific interventions will be listed in the ISA.
Primary outcome measures
- Number of Participants Allocated to Each ISA [Time frame: Baseline to Week 6]
Eligibility criteria
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.
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
- Screening
Study locations
United States · 50 centers
- The Institute for Liver Health II dba Arizona Clinical Trials - Mesa — Chandler
- HOPE Research Institute — Phoenix
- 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
- … and 42 more centers
Argentina · 4 centers
- Cicemo Srl — Buenos Aires
- Centro de Investigaciones Metabólicas (CINME) — Buenos Aires
- Centro Médico Viamonte — Buenos Aires
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires
Identifiers
NCT: NCT06143956 · 18685 · W8M-MC-CWMM · W8M-MC-OXA1 · W8M-MC-LAA1 · W8M-MC-LAA2 · W8M-MC-GN01 · W8M-MC-GN02 · W8M-MC-MC01