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Obesity and OverweightPhase 2LIBERATENCT06847399

Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder

A Phase 2 study testing Tirzepatide, Lisdexamfetamine Dimesylate and Guided self-help cognitive behavioral therapy in people with Obesity and Overweight and Binge Eating Disorder, run by Johns Hopkins University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity and Overweight, Binge Eating Disorder
What is being tested?
Tirzepatide, Lisdexamfetamine Dimesylate and Guided self-help cognitive behavioral therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
1 siteUnited States
Study dates
17 Sep 2025to 1 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease Characteristics
  • Have a BMI ≥30 kg/m2 or ≥27 kg/m2
  • previously diagnosed with at least one obesity-related comorbidity:
  • Have at least one self-reported unsuccessful dietary effort to lose body weight
  • 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)
  • Participant Characteristics
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  • Are 18 years of age or older
  • Participants assigned female at birth: (participants assigned female at birth who are not of childbearing potential may participate and include those who are:
  • 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
  • Participants assigned female at birth of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:
  • 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
  • Informed Consent
  • Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent in accordance with local regulations
  • In the investigator's opinion, are well-motivated, capable, and willing to:
  • 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

Who cannot join

  • Medical Conditions
  • Eating disorder-related
  • Current diagnosis of bulimia nervosa or anorexia nervosa
  • Diabetes-related
  • Have type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma
  • Have laboratory evidence diagnostic of diabetes mellitus during screening, including an HbA1c ≥6.5% or fasting glucose >126 mg/dL
Show all 54Show fewer
  • Obesity-related:
  • Have a self-reported change in body weight >5 kg within 3 months prior to screening
  • Have a prior or planned surgical treatment for obesity (excluding lap-band if removed >6 months prior to screening or liposuction or abdominoplasty if performed >1 year prior to screening)
  • Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (for example, mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal bypass sleeve)
  • Other medical
  • 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
  • Prior/Concomitant Therapy
  • 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)
  • Prior/Concurrent Clinical Study Experience
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abigail Bisson, BS contact

667-306-9366

abisson2@jh.edu

United States1 site, 1 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21146

    Clinical Research Coordinator, 667-306-9366, abisson2@jh.edu

    Recruiting

Other trials in United States

About this study

Official title: Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder: A Randomized Clinical 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.

Being tested
Tirzepatide, Lisdexamfetamine Dimesylate, Guided self-help cognitive behavioral therapy, Placebo (oral), Placebo (injection)
Keywords
obesity, binge eating disorder, tirzepatide, Lisdexamfetamine
Medical subject headings
Obesity, Overweight, Binge-Eating Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Tirzepatide

  • Lisdexamfetamine DimesylateDrug

    Lisdexamfetamine dimesylate

  • Guided self-help cognitive behavioral therapyBehavioural

    Guided self-help cognitive behavioral therapy

  • Placebo (oral)Drug

    Placebo (oral)

  • Placebo (injection)Drug

    Placebo (injection)

Study groups in NCT06847399
Study groupRoleWhat they receive
TirzepatideExperimentalTirzepatide injection + placebo oral capsule
Receives: Drug: Tirzepatide; Behavioral: Guided self-help cognitive behavioral therapy; Drug: Placebo (oral)
Lisdexamfetamine dimesylateActive comparatorPlacebo injection + lisdexamfetamine dimesylate
Receives: Drug: Lisdexamfetamine Dimesylate; Behavioral: Guided self-help cognitive behavioral therapy; Drug: Placebo (injection)
PlaceboPlacebo comparatorPlacebo injection + placebo oral capsule
Receives: Behavioral: Guided self-help cognitive behavioral therapy; Drug: Placebo (oral); Drug: Placebo (injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent initial weight loss

    To compare tirzepatide maximum tolerated dose (MTD) versus placebo from randomization to week 52 for percent initial weight loss

    Measured: Baseline to 52 weeks

  2. Change in the Number of Binge-eating episodes

    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

    Measured: Baseline to 52 weeks

Secondary outcomes (7)

  1. Number of Binge-eating episodes

    To assess the non-inferiority of tirzepatide MTD versus lisdexamfetamine dimesylate MTD 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

    Measured: Baseline to 52 weeks

  2. Percentage of Participants Achieving Binge-eating abstinence

    To compare tirzepatide MTD versus placebo from randomization to week 52 for binge-eating abstinence, defined as percent of study participants who achieve 0 episodes of binge eating in the past 28 days via clinician interview

    Measured: Baseline to 52 weeks

  3. Number of Participants who achieve ≥5% body weight reduction

    To compare tirzepatide MTD versus placebo from randomization to week 52 for percent of study participants who achieve ≥5% body weight reduction. Categorical achievement of weight reduction threshold (≥5% initial weight loss).

    Measured: Baseline to 52 weeks

  4. Number of Participants who achieve ≥10% body weight reduction

    To compare tirzepatide MTD versus placebo from randomization to week 52 for percent of study participants who achieve ≥10% body weight reduction. Categorical achievement of weight reduction threshold (≥10% initial weight loss)

    Measured: Baseline to 52 weeks

  5. Number of Participants who achieve ≥15% body weight reduction

    To compare tirzepatide MTD versus placebo from randomization to week 52 for percent of study participants who achieve ≥15% body weight reduction. Categorical achievement of weight reduction threshold (≥15% initial weight loss)

    Measured: Baseline to 52 weeks

  6. Number of Participants who achieve ≥20% body weight reduction

    To compare tirzepatide MTD versus placebo from randomization to week 52 for percent of study participants who achieve ≥20% body weight reduction. Categorical achievement of weight reduction threshold (≥20% initial weight loss).

    Measured: Baseline to 52 weeks

  7. Clinical global functioning as assessed by the Clinical Global Impressions Scale (CGI) score

    To compare tirzepatide MTD versus placebo from randomization to week 52 for clinical global functioning using change in Clinical Global Impressions Scale (CGI) score. The CGI severity scale rates the severity of a participant's condition (range: 1 [normal, not at all ill] to 7 [among the most extremely ill]). The CGI improvement scale rates overall symptom improvement in the participant's condition relative to baseline (range: 1 [very much improved] to 7 [very much worse]). Score range 0-21. Higher score worse outcome.

    Measured: Baseline to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2025
  2. Study start17 Sep 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06847399
Sponsor's protocol ID
IRB00474917
Acronym
LIBERATE
Status last verified
Sep 2026
First submitted
24 Feb 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide, Lisdexamfetamine Dimesylate and Guided self-help cognitive behavioral therapy in people with Obesity and Overweight and Binge Eating Disorder, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abigail Bisson, BS (667-306-9366, abisson2@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent initial weight loss (time frame: Baseline to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06847399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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