Recruiting
PHASE2
INTERVENTIONAL
NCT06847399
Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to assess the efficacy and safety of tirzepatide in adults with obesity and binge-eating disorder, comparing tirzepatide against placebo and lisdexamfetamine dimesylate. All participants will receive guided self-help cognitive behavioral therapy.
Interventions
Name:
Tirzepatide
Type:
DRUG
Description:
Tirzepatide
Name:
Lisdexamfetamine Dimesylate
Type:
DRUG
Description:
Lisdexamfetamine dimesylate
Name:
Guided self-help cognitive behavioral therapy
Type:
BEHAVIORAL
Description:
Guided self-help cognitive behavioral therapy
Name:
Placebo (oral)
Type:
DRUG
Description:
Placebo (oral)
Name:
Placebo (injection)
Type:
DRUG
Description:
Placebo (injection)
Primary Outcomes
Measure:
Percent initial weight loss
TimeFrame:
Baseline to 52 weeks
Description:
To compare tirzepatide maximum tolerated dose (MTD) versus placebo from randomization to week 52 for percent initial weight loss
Measure:
Change in the Number of Binge-eating episodes
TimeFrame:
Baseline to 52 weeks
Description:
To compare tirzepatide MTD versus placebo from randomization to week 52 for reduction in the number of binge-eating episodes defined as change in the number of binge-eating episodes in the past 28 days measured via clinician interview
Trial Information
NCT ID
NCT06847399
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Johns Hopkins University
Last Updated
December 15, 2025