Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder: A Randomized Clinical Trial
Johns Hopkins University
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Disease Characteristics 1. Have a BMI ≥30 kg/m2 or ≥27 kg/m2 * previously diagnosed with at least one obesity-related comorbidity: 2. Have at least one self-reported unsuccessful dietary effort to lose body weight 3. Meet Diagnostic and Statistical Manual (DSM)-5 criteria for Binge Eating Disorder (BED) as diagnosed by the Eating Disorder Examination interview and confirmed by binge-eating diaries that is moderate or greater in severity (4 or more episodes per week) Participant Characteristics 4. Are 18 years of age or older 5. Participants assigned female at birt…
Interventions
- DrugTirzepatide
Tirzepatide
- DrugLisdexamfetamine Dimesylate
Lisdexamfetamine dimesylate
- BehavioralGuided self-help cognitive behavioral therapy
Guided self-help cognitive behavioral therapy
- DrugPlacebo (oral)
Placebo (oral)
- DrugPlacebo (injection)
Placebo (injection)
Location
- Johns Hopkins UniversityBaltimore, Maryland