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Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06847399•Johns Hopkins University

View on ClinicalTrials.gov

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

18 - No limit years

Sex

ALL

Healthy Volunteers

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 birth: (participants assigned female at birth who are not of childbearing potential may participate and include those who are:
•* infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation), congenital anomaly such as Mullerian agenesis
•* postmenopausal, defined as either
+14 more criteria

Exclusion Criteria

•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
•12. Have a prior or planned surgical treatment for obesity (excluding lap-band if removed \>6 months prior to screening or liposuction or abdominoplasty if performed \>1 year prior to screening)
•13. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (for example, mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal bypass sleeve)
+44 more criteria

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Key Dates

Start Date

September 17, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

September 22, 2025

Enrollment

105

ESTIMATED participants

Conditions

Obesity and OverweightBinge Eating Disorder

Interventions

Tirzepatide

DRUG

Lisdexamfetamine Dimesylate

DRUG

Guided self-help cognitive behavioral therapy

BEHAVIORAL

Placebo (oral)

DRUG

Placebo (injection)

DRUG

Contacts

Abigail Bisson, BS

CONTACT

667-306-9366 abisson2@jh.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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