Study of Tirzepatide for Binge-Eating Disorder and Obesity
This study is looking at how well tirzepatide works and if it's safe for adults who have obesity and binge-eating disorder. We are comparing tirzepatide to a placebo (an inactive substance) and to another medication called lisdexamfetamine dimesylate. All participants will also receive guided self-help cognitive behavioral therapy. To join, you need to be an adult with a BMI of 30 or higher (or 27 or higher with an obesity-related health issue), have tried to lose weight before, and meet the criteria for Binge Eating Disorder. The study will measure changes in weight and the number of binge-eating episodes over 52 weeks to see how effective the treatments are. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 105 participants. It compares tirzepatide against placebo and lisdexamfetamine dimesylate.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 52 weeks to measure changes in weight and binge-eating episodes.
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NCT06847399
Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
Recruiting
PHASE2Ages 18+InterventionalTreatmentJohns Hopkins UniversityInvestigator-initiated
~105 participants
Updated 2025-09-22 on ClinicalTrials.gov
What's tested:TirzepatideLisdexamfetamine DimesylateGuided self-help cognitive behavioral therapyPlacebo (oral)Placebo (injection)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent initial weight loss
Measured over Baseline to 52 weeks
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Ariana M Chao, PhD, CRNP, FNP-BC · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
previously diagnosed with at least one obesity-related comorbidity: 2. Have at least one self-reported unsuccessful dietary effort to lose body weight 3. Meet Diagnostic and Statistical Manual (DSM)-5 criteria for Binge Eating Disorder (BED) as diagnosed by the Eating Disorder Examination interview and confirmed by binge-eating diaries that is moderate or greater in severity (4 or more episodes per week)
infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation), congenital anomaly such as Mullerian agenesis
postmenopausal, defined as either
a female at least 40 years of age with an intact uterus, not on hormone therapy and who has cessation of menses for at least 1 year without an alternative medical cause; women in this category must test negative in pregnancy test prior to study entry OR
a female 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea OR
a female at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
test negative for pregnancy at Visit 1 based on a serum pregnancy test
and if sexually active, agree in writing to use 2 forms of effective contraception, where at least 1 form is highly effective, for the duration of the trial
not be breastfeeding
Learn how to self-inject study drug, as required for this protocol (persons with visual impairments or physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject study drug)
Inject study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Learn how to take oral capsules, be consistently able to swallow capsules, and willing to take oral capsules daily as required for this protocol
Follow study procedures for the duration of the study
Exclusion
Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2
Known serious hypersensitivity to tirzepatide or lisdexamfetamine dimesylate or any of the excipients in the medications
Have severe gastrointestinal disease
Have known clinically significant renal impairment
Have uncontrolled medical conditions or contraindications to tirzepatide or lisdexamfetamine dimesylate
Have personal or family history of cardiovascular disease that could increase vulnerability to sympathomimetic effects of psychostimulants
Have a history of suspected substance abuse within the past 5 years
Have a lifetime history of psychostimulant abuse and/or dependence
Have glaucoma
Have had a history of chronic or acute pancreatitis
Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome)
Have a current diagnosis of attention-deficit/hyperactivity disorder
Have a history of significant active or unstable Major Depressive Disorder (MDD; within the last 2 years) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, psychosis, mania, hypomania, or other serious mood or anxiety disorder) Note: Patients with MDD or generalized anxiety disorder whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if not on excluded medications
Have a Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at Visit 1 or 2, prior to randomization
Have any lifetime history of a suicide attempt
Individual is considered a suicide risk in the opinion of the investigator; or endorsement of current, active suicidal ideation at screening or randomization. On the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visits 1 or 2, prior to randomization:
a "yes" answer to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or
a "yes" answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS or
a "yes" answer to any of the suicide-related behaviors (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Act or Behavior) on the "Suicidal Behavior" portion of the C-SSRS and
the ideation or behavior occurred within the past month
Have taken monoamine oxidate inhibitors (MAOI), or within 14 days of stopping MAOIs
Have uncontrolled hypertension (SBP above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
Have any of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction (MI), cerebrovascular accident (stroke), unstable angina
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
History of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, Parkinson's disease, or intracranial lesions
Participant has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place the participant at increased vulnerability to the sympathomimetic effects of a stimulant medication
Have a history of any other condition that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
Are receiving concurrent treatment for eating or weight disorders
Use of a psychostimulant within the past 6 months
Have taken within 3 months prior to screening, medications (prescribed or over-the counter) intended to promote weight loss. Examples include, but are not limited to
Saxenda® (liraglutide 3.0 mg)
Xenical®/Alli® (orlistat)
Meridia® (sibutramine)
Adipex® (phentermine)
BELVIQ® (lorcaserin)
Qsymia® (phentermine/topiramate combination)
Contrave® (naltrexone/bupropion)
Ozempic or Wegovy (semaglutide)
Mounjaro or Zepbound (tirzepatide)
Rybelsus (semaglutide)
Are currently enrolled in any other clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
What this trial measures
- Percent initial weight lossBaseline to 52 weeks
To compare tirzepatide maximum tolerated dose (MTD) versus placebo from randomization to week 52 for percent initial weight loss
- Change in the Number of Binge-eating episodesBaseline to 52 weeks
To compare tirzepatide MTD versus placebo from randomization to week 52 for reduction in the number of binge-eating episodes defined as change in the number of binge-eating episodes in the past 28 days measured via clinician interview