Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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 criteria
Qualifiers
Have a BMI ≥30 kg/m2 or ≥27 kg/m2
Have at least one self-reported unsuccessful dietary effort to lose body weight
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)
Are 18 years of age or older
Disqualifiers
Current diagnosis of bulimia nervosa or anorexia nervosa
Have type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma
Have laboratory evidence diagnostic of diabetes mellitus during screening, including an HbA1c ≥6.5% or fasting glucose >126 mg/dL
Have a self-reported change in body weight >5 kg within 3 months prior to screening
Trial design
Treatments tested in this trial
- Tirzepatide
- Lisdexamfetamine Dimesylate
- Guided self-help cognitive behavioral therapy
- Placebo (oral)
- Placebo (injection)
Treatment groups
105 Participants
are divided into 3 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov