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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugTirzepatide
Lisdexamfetamine Dimesylate
DrugLisdexamfetamine dimesylate
Guided self-help cognitive behavioral therapy
BehavioralGuided self-help cognitive behavioral therapy
Placebo (oral)
DrugPlacebo (oral)
Placebo (injection)
DrugPlacebo (injection)
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: TirzepatideExperimental treatment 3 interventions
Group B: Lisdexamfetamine dimesylateActive comparator 3 interventions
Group C: PlaceboPlacebo comparator 3 interventions
Trial outcomes
Primary outcomes
1
Percent initial weight loss
To compare tirzepatide maximum tolerated dose (MTD) versus placebo from randomization to week 52 for percent initial weight loss
Time frame
Baseline to 52 weeks2
Change in the Number of Binge-eating episodes
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
Time frame
Baseline to 52 weeksSecondary outcomes
1
Number of Binge-eating episodes
To assess the non-inferiority of tirzepatide MTD versus lisdexamfetamine dimesylate MTD 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
Time frame
Baseline to 52 weeks2
Percentage of Participants Achieving Binge-eating abstinence
To compare tirzepatide MTD versus placebo from randomization to week 52 for binge-eating abstinence, defined as percent of study participants who achieve 0 episodes of binge eating in the past 28 days via clinician interview
Time frame
Baseline to 52 weeks3
Number of Participants who achieve ≥5% body weight reduction
To compare tirzepatide MTD versus placebo from randomization to week 52 for percent of study participants who achieve ≥5% body weight reduction. Categorical achievement of weight reduction threshold (≥5% initial weight loss).
Time frame
Baseline to 52 weeks4
Number of Participants who achieve ≥10% body weight reduction
To compare tirzepatide MTD versus placebo from randomization to week 52 for percent of study participants who achieve ≥10% body weight reduction. Categorical achievement of weight reduction threshold (≥10% initial weight loss)
Time frame
Baseline to 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov