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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06847399
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Binge Eating Disorder
  • Obesity and Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Tirzepatide
  • Lisdexamfetamine Dimesylate — DRUG
    Lisdexamfetamine dimesylate
  • Guided self-help cognitive behavioral therapy — BEHAVIORAL
    Guided self-help cognitive behavioral therapy
  • Placebo (oral) — DRUG
    Placebo (oral)
  • Placebo (injection) — DRUG
    Placebo (injection)

Study Details

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.

Key Dates

Start date
Sep 17, 2025
Status verified
Sep 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Tirzepatide injection + placebo oral capsule
  • Active Comparator: Lisdexamfetamine dimesylate
    Placebo injection + lisdexamfetamine dimesylate
  • Placebo Comparator: Placebo
    Placebo injection + placebo oral capsule

Primary Outcome Measure

Percent initial weight loss [ Time Frame: Baseline to 52 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21146
Clinical Research Coordinator
[email protected]
667-306-9366

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University· Baltimore, MD

Related Studies