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Evaluating interventions for managing obesity and overweight

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight

Phase 2 Interventional Eli Lilly and Company · NCT06143956

This study is testing different new treatments to see if they can help people with obesity and overweight manage their weight safely and effectively.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment1217 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations53 sites (Chandler, Arizona and 52 other locations)
Trial IDNCT06143956 on ClinicalTrials.gov

What this trial studies

This Phase-2 chronic weight management master protocol aims to assess the safety and efficacy of various investigational treatments for obesity and overweight. The study utilizes a framework that allows for the evaluation of multiple intervention-specific appendices (ISAs), which can be initiated independently as they become available. Participants will be screened based on specific entry criteria, and results will be reported once all ISAs are completed.

Who should consider this trial

Good fit: Ideal candidates are adults with a BMI of 27 kg/m² or higher, or those with a BMI of 30 kg/m² or higher, who have maintained stable body weight for the past three months.

Not a fit: Patients with a history of certain cardiovascular conditions, poorly controlled hypertension, or prior surgical treatments for obesity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new effective treatment options for individuals struggling with obesity and overweight.

How similar studies have performed: Other studies have shown promise in evaluating interventions for obesity, but this master protocol approach with multiple ISAs is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Chandler, Arizona and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityOverweight
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.