NCT06847399

Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder

Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder: A Randomized Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity and Overweight
• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	Tirzepatide	Tirzepatide
DRUG	Lisdexamfetamine Dimesylate	Lisdexamfetamine dimesylate
BEHAVIORAL	Guided self-help cognitive behavioral therapy	Guided self-help cognitive behavioral therapy
DRUG	Placebo (oral)	Placebo (oral)
DRUG	Placebo (injection)	Placebo (injection)

Timeline

• Start date: 2025-09-17
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-02-26
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study