Evaluating interventions for managing obesity and overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
  Chandler, Arizona, United States Recruiting
• Headlands Research - Scottsdale
  Scottsdale, Arizona, United States Recruiting
• The Institute for Liver Health II dba Arizona Liver Health-Tucson
  Tucson, Arizona, United States Recruiting
• NorCal Medical Research, Inc
  Greenbrae, California, United States Recruiting
• Velocity Clinical Research, Huntington Park
  Huntington Park, California, United States Recruiting
• Peninsula Research Associates
  Rolling Hills Estates, California, United States Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.