NCT06143956 · Eli Lilly and Company
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
What this study is about
The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and effectiveness of various experimental 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.
View original scientific description
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.
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
Each ISA will detail the intervention specific analysis.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 pa
Where
- Chandler, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Greenbrae, California
- Huntington Park, California
- Rolling Hills Estates, California
- Walnut Creek, California
- Stamford, Connecticut
- Fleming Island, Florida
- Miami, Florida
- Miami Lakes, Florida
And 35 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations