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

NCT06847399 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Obesity and Overweight
  • Binge Eating Disorder

Interventions

DRUG

Tirzepatide

Tirzepatide

DRUG

Lisdexamfetamine Dimesylate

Lisdexamfetamine dimesylate

BEHAVIORAL

Guided self-help cognitive behavioral therapy

Guided self-help cognitive behavioral therapy

DRUG

Placebo (oral)

Placebo (oral)

DRUG

Placebo (injection)

Placebo (injection)

Sponsors & Collaborators

Principal Investigators

  • Ariana M Chao, PhD, CRNP, FNP-BC · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-17
Primary Completion
2027-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06847399 on ClinicalTrials.gov