Actively Recruiting
Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder: A Randomized Clinical Trial
Led by Johns Hopkins University · Updated on 2025-09-22
105
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of tirzepatide in adults who have obesity and binge-eating disorder. This study compares tirzepatide to placebo and lisdexamfetamine dimesylate, while all participants receive guided self-help cognitive behavioral therapy. The trial is designed as a randomized clinical trial to better understand these treatments in managing binge-eating disorder with related obesity. Participants will be randomly assigned to one of three groups: tirzepatide injection with a placebo oral capsule, placebo injection with lisdexamfetamine dimesylate, or placebo injection with placebo oral capsule. All participants will also engage in guided self-help cognitive behavioral therapy during the study. Treatments are given over a period of 52 weeks with regular monitoring. Throughout the study, participants will be assessed for changes in body weight and the number of binge-eating episodes. Researchers will collect data on weight loss percentage, binge-eating episode frequency, and clinical global functioning. Safety and effectiveness will be monitored for one year, with participants expected to follow study procedures including injections, capsule intake, and therapy sessions.
CONDITIONS
Brief Title
Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a BMI of 30 kg/m2 or higher, or 27 kg/m2 with at least one obesity-related condition
- Have tried and been unsuccessful at losing weight through diet
- Meet DSM-5 criteria for moderate or greater binge-eating disorder with 4 or more episodes per week
- Are 18 years of age or older
- If assigned female at birth and of childbearing potential, must use two forms of contraception and have a negative pregnancy test
- Understand and are willing to follow study procedures and provide written informed consent
- Are willing and able to self-inject the study drug or have assistance
- Are willing and able to take oral capsules daily as required
You will not qualify if you...
- Current diagnosis of bulimia nervosa or anorexia nervosa
- Have type 1 or type 2 diabetes, or laboratory evidence of diabetes at screening
- Recent weight change over 5 kg in past 3 months
- Prior or planned obesity surgery or device-based obesity treatment within specified timeframes
- Personal or family history of certain cancers or endocrine disorders
- Known allergy to study drugs or their components
- Severe gastrointestinal disease or significant kidney problems
- Uncontrolled medical conditions or contraindications to study drugs
- History of substance abuse or psychostimulant dependence
- Current attention-deficit/hyperactivity disorder
- History of severe psychiatric disorders or recent suicide risk
- Use of monoamine oxidase inhibitors within 14 days
- Uncontrolled high blood pressure or recent serious cardiovascular events
- History of seizures, neurological diseases, or serious cardiac problems
- Use of weight-loss medications within 3 months prior to screening
- Currently enrolled in incompatible clinical studies or receiving treatment for eating or weight disorders
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive assigned study drugs or placebo along with guided self-help cognitive behavioral therapy for binge-eating disorder.
Regular visits throughout the 52 weeks
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21146
Actively Recruiting
Research Team
A
Abigail Bisson, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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