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

NCT06847399 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB00474917
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity and Overweight; Binge Eating Disorder

Keywords

obesity; binge eating disorder; tirzepatide; Lisdexamfetamine

Outcome Measures

Primary Outcomes (2)

• Percent initial weight loss

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

  Baseline to 52 weeks

• 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

  Baseline to 52 weeks

Secondary Outcomes (7)

• Number of Binge-eating episodes

  Baseline to 52 weeks

• Percentage of Participants Achieving Binge-eating abstinence

  Baseline to 52 weeks

• Number of Participants who achieve ≥5% body weight reduction

  Baseline to 52 weeks

• Number of Participants who achieve ≥10% body weight reduction

  Baseline to 52 weeks

• Number of Participants who achieve ≥15% body weight reduction

  Baseline to 52 weeks

Study Arms (3)

Tirzepatide

EXPERIMENTAL

Tirzepatide injection + placebo oral capsule

Drug: Tirzepatide; Behavioral: Guided self-help cognitive behavioral therapy; Drug: Placebo (oral)

Lisdexamfetamine dimesylate

ACTIVE COMPARATOR

Placebo injection + lisdexamfetamine dimesylate

Drug: Lisdexamfetamine Dimesylate; Behavioral: Guided self-help cognitive behavioral therapy; Drug: Placebo (injection)

Placebo

PLACEBO COMPARATOR

Placebo injection + placebo oral capsule

Behavioral: Guided self-help cognitive behavioral therapy; Drug: Placebo (oral); Drug: Placebo (injection)

Interventions

Tirzepatide DRUG

Tirzepatide

Tirzepatide

Lisdexamfetamine Dimesylate DRUG

Lisdexamfetamine dimesylate

Lisdexamfetamine dimesylate

Guided self-help cognitive behavioral therapy BEHAVIORAL

Guided self-help cognitive behavioral therapy

Lisdexamfetamine dimesylate; Placebo; Tirzepatide

Placebo (oral) DRUG

Placebo (oral)

Placebo; Tirzepatide

Placebo (injection) DRUG

Placebo (injection)

Lisdexamfetamine dimesylate; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21146, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Binge-Eating Disorder

Interventions

Tirzepatide; Lisdexamfetamine Dimesylate; Injections

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ariana M Chao, PhD, CRNP, FNP-BC

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Bisson, BS

CONTACT

667-306-9366; abisson2@jh.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 26, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)