Actively Recruiting
Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
Led by Johns Hopkins University · Updated on 2025-09-22
105
Participants Needed
1
Research Sites
115 weeks
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
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.
CONDITIONS
Official 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 body mass index (BMI) of 30 kg/m2 or higher, or 27 kg/m2 or higher with at least one obesity-related health condition
- Have at least one self-reported unsuccessful attempt to lose weight through diet
- Meet the Diagnostic and Statistical Manual (DSM)-5 criteria for moderate or greater binge eating disorder with 4 or more episodes per week
- Be 18 years of age or older
- Participants assigned female at birth who are not of childbearing potential may participate, including those infertile due to surgery or congenital anomaly, postmenopausal, or 55 years or older
- Female participants of childbearing potential must test negative for pregnancy at the start and agree to use two forms of contraception if sexually active
- Understand and agree to follow study procedures and give written informed consent
- Be willing and able to learn self-injection or receive assistance, take oral capsules daily, and comply with study requirements
You will not qualify if you...
- Current diagnosis of bulimia nervosa or anorexia nervosa
- Have type 1 or type 2 diabetes mellitus, history of ketoacidosis, or hyperosmolar state
- Laboratory evidence of diabetes during screening (HbA1c ≥6.5% or fasting glucose >126 mg/dL)
- Weight change greater than 5 kg in the past 3 months
- Prior or planned surgical treatment for obesity within specified timeframes
- Prior or planned endoscopic or device-based therapy for obesity within 6 months
- Family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2
- Known serious allergy to study drugs or their ingredients
- Severe gastrointestinal disease or significant kidney problems
- Uncontrolled medical conditions or contraindications to study drugs
- Personal or family history of cardiovascular disease increasing risk with stimulant medications
- History of substance abuse within 5 years or lifetime psychostimulant abuse
- Glaucoma, pancreatitis, certain endocrine or genetic obesity disorders
- Current diagnosis of attention-deficit/hyperactivity disorder
- Recent or unstable major depressive disorder or severe psychiatric disorders
- High Patient Health Questionnaire-9 (PHQ-9) score or history of suicide attempts or risk
- Recent use of monoamine oxidase inhibitors
- Uncontrolled high blood pressure
- Cardiovascular events within 3 months prior to study
- History of active or untreated cancers within 5 years
- History of seizures, neurological diseases, or serious heart conditions
- Any other condition that may prevent following the study protocol
- Receiving concurrent treatment for eating or weight disorders
- Use of psychostimulants within the past 6 months
- Use of weight loss medications within 3 months prior
- Current participation in incompatible clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21146
Actively Recruiting
Research Team
A
Abigail Bisson, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here