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

What Was Tested

In this phase 2 trial, researchers set out to test Tirzepatide.

All participants will receive guided self-help cognitive behavioral therapy.

It had three arms (groups): Tirzepatide (experimental), Lisdexamfetamine dimesylate (active comparator) and Placebo (placebo comparator).

Tirzepatide injection + placebo oral capsule.

Placebo injection + lisdexamfetamine dimesylate.

Placebo injection + placebo oral capsule.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 105 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have a BMI ≥30 kg/m2 or ≥27 kg/m2. Previously diagnosed with at least one obesity-related comorbidity:. Have at least one self-reported unsuccessful dietary effort to lose body weight. Are 18 years of age or older. Participants assigned female at birth: (participants assigned female at birth who are not of childbearing potential may participate and include those who are:.

The full record lists 20 inclusion and 47 exclusion criteria; among the exclusions: 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 a self-reported change in body weight \>5 kg within 3 months prior to screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-09-17 with completion listed for 2027-12-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent initial weight loss (time frame: Baseline to 52 weeks). Change in the Number of Binge-eating episodes (time frame: Baseline to 52 weeks).

It also tracked 7 secondary outcomes, for example Number of Binge-eating episodes, Percentage of Participants Achieving Binge-eating abstinence and Clinical global functioning as assessed by the Clinical Global Impressions Scale (CGI) score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 105 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.