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

NCT06847399 · Recruiting

Last updated 2026-05-28

This clinical trial tests whether tirzepatide, a medication, helps people with obesity or overweight and binge-eating disorder lose weight compared to a placebo or another medication.

Status Recruiting Currently enrolling participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 105 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2025-09 · est. completion 2027-12

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT06847399 ↗

Description as written by the study sponsor.

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.

Treatments tested

Tirzepatide Drug

Tirzepatide
Lisdexamfetamine Dimesylate Drug

Lisdexamfetamine dimesylate
Guided self-help cognitive behavioral therapy Behavioral

Guided self-help cognitive behavioral therapy
Placebo (oral) Drug

Placebo (oral)
Placebo (injection) Drug

Placebo (injection)

Main thing measured	Percent initial weight loss
Sponsor	Johns Hopkins University
Conditions studied	Obesity and Overweight, Binge Eating Disorder
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06847399 ↗