Actively Recruiting
Study of Tirzepatide Compared to Placebo or Lisdexamfetamine Dimesylate for Treating Binge-Eating Disorder in Adults with Obesity
Led by Johns Hopkins University · Updated on 2025-09-22
105
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of tirzepatide in adults who have obesity and binge-eating disorder. This study compares tirzepatide to placebo and lisdexamfetamine dimesylate, while all participants receive guided self-help cognitive behavioral therapy. The trial is designed as a randomized clinical trial to better understand these treatments in managing binge-eating disorder with related obesity. Participants will be randomly assigned to one of three groups tirzepatide injection with a placebo oral capsule, placebo injection with lisdexamfetamine dimesylate, or placebo injection with placebo oral capsule. All participants will also engage in guided self-help cognitive behavioral therapy during the study. Treatments are given over a period of 52 weeks with regular monitoring. Throughout the study, participants will be assessed for changes in body weight and the number of binge-eating episodes. Researchers will collect data on weight loss percentage, binge-eating episode frequency, and clinical global functioning. Safety and effectiveness will be monitored for one year, with participants expected to follow study procedures including injections, capsule intake, and therapy sessions.
CONDITIONS
Brief Title
Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
Research Team
A
Abigail Bisson, BS
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