LIBERATE begins: the first randomized test of tirzepatide for binge eating disorder

A phase 2 clinical trial called LIBERATE has started randomizing adults with obesity and binge-eating disorder to one of three groups: tirzepatide, the stimulant lisdexamfetamine dimesylate, or placebo ^[1]. The study, registered on ClinicalTrials.gov as NCT06847399, is run by Johns Hopkins in partnership with Eli Lilly, the maker of tirzepatide, which is sold as Mounjaro for type 2 diabetes and Zepbound for weight management ^[1]. This is the first randomized test of tirzepatide specifically for binge-eating disorder.

The trial plans to enroll 105 adults ^[1]. Every participant, regardless of which drug or placebo they receive, will also get guided self-help cognitive behavioral therapy, a structured form of talk therapy that participants largely work through on their own with periodic support ^[1]. The main question researchers want answered is how much the number of binge-eating episodes changes after 52 weeks of treatment ^[1]. The study's estimated completion date is December 2027 ^[1].

Binge-eating disorder involves repeated episodes of eating unusually large amounts of food with a sense of loss of control, and it is not the same as bulimia because it does not involve regular purging. The trial's design, comparing an active drug already approved for obesity and diabetes against both a placebo and an existing stimulant medication used for binge-eating disorder, will let researchers see how tirzepatide stacks up against a treatment already on the market as well as against no drug at all ^[1].

Why it matters for patients

GLP-1 and dual GLP-1/GIP drugs like tirzepatide are already widely used for weight loss and diabetes, but they are not currently approved to treat binge-eating disorder. Some patients and doctors have wondered whether the appetite and reward-related effects of these drugs might also reduce binge episodes, but until now there has been no randomized trial testing that idea directly ^[1]. LIBERATE is designed to produce the kind of controlled evidence that regulators and clinicians look for before recommending a medication for a specific condition.

For people currently living with binge-eating disorder and obesity, the trial does not change what is available today. Lisdexamfetamine dimesylate remains an existing option that is part of the comparison arm, and tirzepatide's use for this specific disorder is still investigational ^[1]. Anyone considering treatment options for binge-eating disorder would need to discuss what is currently approved and appropriate with a health care provider, since this trial's results will not be available for years.

The fact that Lilly is a partner in the trial signals commercial interest in expanding tirzepatide's approved uses beyond diabetes and obesity, but a phase 2 trial is an early step. Even if results are positive, additional larger trials and regulatory review would likely be needed before any approval for this specific use.

What happens next

The trial is enrolling now, with adults with obesity and binge-eating disorder randomized among the three arms and receiving guided self-help therapy ^[1]. The estimated primary completion and study completion date is December 2027, when researchers expect to have full results on the 52-week change in binge-eating episodes across the three groups ^[1].