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RecruitingObesity and OverweightBinge Eating Disorder

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Johns Hopkins University

You may qualify if…

  • ✓ 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 birth: (participants assigned female at birth who are not of childbearing potential may participate and include those who are:

You may not qualify if…

  • ✕ Medical Conditions
  • ✕ Eating disorder-related
  • ✕ 8. Current diagnosis of bulimia nervosa or anorexia nervosa
  • ✕ Diabetes-related
  • ✕ 9. Have type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma
  • ✕ 10. Have laboratory evidence diagnostic of diabetes mellitus during screening, including an HbA1c ≥6.5% or fasting glucose \>126 mg/dL
  • ✕ Obesity-related:
  • ✕ 11. Have a self-reported change in body weight \>5 kg within 3 months prior to screening

Where it's recruiting

Maryland

Baltimore

Source: ClinicalTrials.gov · NCT06847399 · last updated 2025-09-22