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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Guided self-help cognitive behavioral therapy for Binge Eating Disorder?

Research shows that guided self-help cognitive behavioral therapy (CBT) is effective for treating binge eating disorder. Studies found that this approach significantly reduces binge eating episodes and improves related symptoms, with benefits maintained over time. ^{1 2 3 4 5}

How does the drug Tirzepatide differ from other treatments for binge eating disorder?

Tirzepatide is unique because it is a GLP-1 receptor agonist, similar to liraglutide, which is being explored for its potential to help with binge eating disorder by affecting appetite regulation and weight loss. Unlike other treatments, it may offer a novel mechanism of action by targeting the body's natural hormone pathways involved in hunger and satiety. ^{6 7 8 9 10}

Research Team

Ariana M Chao, PhD, CRNP, FNP-BC

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. United States 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. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy-Enhanced for Binge Eating Disorder: Randomized Controlled Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. [2018]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled comparison of guided self-help cognitive behavioral therapy and behavioral weight loss for binge eating disorder. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of binge-eating disorder: a review. [2015]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacological approaches to the management of binge eating disorder. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Acamprosate in the treatment of binge eating disorder: a placebo-controlled trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of liraglutide 3.0 mg for binge eating disorder. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Utility of an experimental medicine model to evaluate efficacy, side-effects and mechanism of action of novel treatments for obesity and binge-eating disorder. [2022]