Tirzepatide for Binge Eating Disorder

(LIBERATE Trial)

Overseen By Abigail Bisson, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: MAOIs, Psychostimulants, Weight-loss drugs

Disqualifiers: Diabetes, Bulimia, Severe psychiatric disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tirzepatide for individuals with obesity and binge-eating disorder. Researchers aim to compare the effectiveness of tirzepatide against a placebo (a substance with no active ingredient) and lisdexamfetamine dimesylate (a medication for ADHD). All participants will also receive guided self-help cognitive behavioral therapy, a form of talk therapy. Suitable candidates for this trial are adults who are obese and experience frequent binge-eating episodes (four or more times a week) despite efforts to lose weight. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used certain weight loss medications or psychostimulants recently. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, medications like tirzepatide, known as GLP-1 receptor agonists, have shown promise in aiding binge eating and weight loss. Research suggests these medications are generally well-tolerated, with common side effects such as nausea or diarrhea.

The FDA has already approved tirzepatide for treating diabetes, which provides some reassurance about its safety. However, since this trial is in an early stage, the researchers are still learning about its safety for treating binge eating disorder. So far, the side effects reported mirror those experienced by individuals using it for diabetes.

Participants should feel encouraged by tirzepatide's safety record in other conditions, but discussing any concerns with the study team remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about tirzepatide for binge eating disorder because it targets the body's metabolic pathways, which is different from the usual focus on neurotransmitters like dopamine and norepinephrine that current treatments such as lisdexamfetamine dimesylate use. Tirzepatide is a dual GIP and GLP-1 receptor agonist, which not only helps regulate appetite but also affects glucose metabolism, potentially offering a more comprehensive approach to managing binge eating behaviors. This dual mechanism could lead to improved outcomes for patients by addressing both the psychological and physiological aspects of binge eating disorder.

What evidence suggests that this trial's treatments could be effective for binge eating disorder?

Research has shown that tirzepatide, which participants in this trial may receive, might help people with binge eating disorder by reducing binge episodes and aiding in weight loss. Small studies on similar drugs, such as GLP-1 receptor agonists, have demonstrated a decrease in binge eating and body weight. For instance, individuals with binge eating disorder lost an average of 6.2 kg using these medications. These findings suggest that tirzepatide could effectively manage symptoms of binge eating disorder and obesity. ^{3 4 6 7 8}

Who Is on the Research Team?

Ariana M Chao, PhD, CRNP, FNP-BC

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with obesity and binge-eating disorder. Participants will also receive cognitive behavioral therapy to help manage their eating habits.

Inclusion Criteria

I am not able to become pregnant and meet specific criteria.

My BMI is 27 or higher.

Have at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria

Have a self-reported change in body weight >5 kg within 3 months prior to screening

Current diagnosis of bulimia nervosa or anorexia nervosa

I am receiving or planning to receive treatment for obesity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide, placebo, or lisdexamfetamine dimesylate for binge-eating disorder, along with guided self-help cognitive behavioral therapy

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Guided self-help cognitive behavioral therapy

Trial Overview The study aims to test the effectiveness and safety of tirzepatide compared to a placebo injection or lisdexamfetamine dimesylate, which is another medication used for binge-eating.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 3 Interventions

Tirzepatide injection + placebo oral capsule

Group II: Lisdexamfetamine dimesylate Active Control 3 Interventions

Placebo injection + lisdexamfetamine dimesylate

Group III: Placebo Placebo Group 3 Interventions

Placebo injection + placebo oral capsule

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Guided self-help cognitive behavioral therapy-enhanced (CBT-E) significantly reduced binge eating episodes from an average of 19 to 3 binges over 12 weeks, with 40% of participants achieving full recovery, indicating its efficacy as a treatment for binge eating disorder.

The study involved 180 patients in a randomized controlled trial, and while the guided self-help CBT-E group showed superior results initially, both groups had similar outcomes at follow-up after receiving treatment, highlighting the importance of access to timely care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy-Enhanced for Binge Eating Disorder: Randomized Controlled Trial. Melisse, B., Berg, EVD., Jonge, M., et al.[2023]

A randomized controlled study involving 74 women demonstrated that an Internet-guided self-help program based on cognitive behavioral therapy (CBT) significantly improved binge eating behaviors and related psychological factors over six months, with benefits maintained at a six-month follow-up.

The program was well-accepted by participants, indicating that transferring CBT techniques to an online format can effectively address binge eating disorder (BED) symptoms and improve overall eating disorder psychopathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. Carrard, I., Crépin, C., Rouget, P., et al.[2022]

In a 17-week pilot study involving 27 adults with binge eating disorder (BED), liraglutide 3.0 mg/day led to a significant weight loss of 5.2% compared to 0.9% in the placebo group, indicating its potential efficacy for weight management in BED.

While both liraglutide and placebo groups experienced reductions in binge eating episodes, the difference in the number of objective binge episodes per week was not statistically significant, suggesting that while liraglutide may aid in weight loss, its effect on binge eating frequency needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of liraglutide 3.0 mg for binge eating disorder. Allison, KC., Chao, AM., Bruzas, MB., et al.[2023]

Cognitive-behavioral therapy led by a therapist (CBTth) is significantly more effective than guided self-help (CBTgsh) for treating binge-eating disorder, with a 20-fold higher likelihood of treatment completion and nearly 15-fold higher likelihood of remission based on a study of 457 participants.

Weight concern plays a crucial role in treatment outcomes, with lower weight concern associated with better remission rates in both CBT methods, but longer treatment duration positively impacts remission in CBTth while negatively affecting CBTgsh.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical moderators and predictors of cognitive-behavioral therapy by guided-self-help versus therapist-led for binge-eating disorder: Analysis of aggregated clinical trials. Grilo, CM., Thompson-Brenner, H., Shingleton, RM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06847399

Efficacy and Safety of Tirzepatide Versus Placebo or ... The purpose of this study is to assess the efficacy and safety of tirzepatide in adults with obesity and binge-eating disorder, comparing tirzepatide ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11322710/

Anti-obesity Drugs for the Treatment of Binge Eating Disorder When crossed over to placebo, they regained weight on average about 1.5%. When examining weight loss by diagnosis, BED patients lost an average of 6.2 kg (SD ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214623724000048

GLP-1 receptor agonists: A novel pharmacotherapy for ... Small pilot studies show GLP-1RAs like liraglutide reduce binge eating, body weight, and comorbidities in binge eating disorder and bulimia nervosa.

4. withpower.com withpower.com/trial/phase-2-overweight-5-2025-2b07e

Tirzepatide for Binge Eating Disorder (LIBERATE Trial) In a 17-week pilot study involving 27 adults with binge eating disorder (BED), liraglutide 3.0 mg/day led to a significant weight loss of 5.2% compared to 0.9% ...

5. anad.org anad.org/glp-1-medications-eating-disorders/

GLP-1 Medications & Eating Disorders There are a few small, short-term studies (a few weeks to 6 months) that suggest these medications may help reduce binge episodes, promote ...

6. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10915596/

GLP-1 receptor agonists: A novel pharmacotherapy for binge ... Small pilot studies show GLP-1RAs like liraglutide reduce binge eating, body weight, and comorbidities in binge eating disorder and bulimia nervosa.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306987717309076

Would glucagon-like peptide-1 receptor agonists have ... Binge eating is a core symptom of the eating disorders binge eating disorder (BED) and bulimia nervosa (BN). Both BED and BN are important public health ...