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

Launched by ELI LILLY AND COMPANY · Nov 21, 2023

Keywords

ClinConnect Summary

This clinical trial, called LY900038, is looking to find safe and effective ways to help adults with obesity or who are overweight manage their weight long-term. It is a Phase-2 study, which means it is testing new treatments to see how well they work. The trial has a flexible structure that allows different treatments to be tested independently. If you are between the ages of 18 and 75, have a body mass index (BMI) of 27 or higher, and have maintained a stable weight for the past three months, you might be eligible to participate.

If you join the trial, you will have the chance to try one of the new weight management interventions while being closely monitored by healthcare professionals. However, there are some important factors that could prevent you from participating, such as having certain serious health conditions or previous obesity surgeries. Overall, this trial aims to gather information that could lead to better options for managing weight for people struggling with obesity.

Gender

ALL

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.