Trial · NCT06847399
Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
NCT06847399, Phase 2, Recruiting, Johns Hopkins University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder. Trials, record NCT06847399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06847399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
- NCT number
- NCT06847399
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 105 participants, estimated
- Lead sponsor
- Johns Hopkins University
- Conditions
- Obesity and Overweight, Binge Eating Disorder
- Interventions
- Tirzepatide, Lisdexamfetamine Dimesylate, Guided self-help cognitive behavioral therapy, Placebo (oral), Placebo (injection)
- First posted
- 2025-02-26
- Last updated
- 2026-09-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent initial weight loss | Baseline to 52 weeks | To compare tirzepatide maximum tolerated dose (MTD) versus placebo from randomization to week 52 for percent initial weight loss |
| Primary | Change in the Number of Binge-eating episodes | Baseline 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 |
| Secondary | Number of Binge-eating episodes | Baseline to 52 weeks | 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 |
| Secondary | Percentage of Participants Achieving Binge-eating abstinence | Baseline to 52 weeks | 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 |
| Secondary | Number of Participants who achieve ≥5% body weight reduction | Baseline to 52 weeks | 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). |
| Secondary | Number of Participants who achieve ≥10% body weight reduction | Baseline to 52 weeks | 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) |
| Secondary | Number of Participants who achieve ≥15% body weight reduction | Baseline to 52 weeks | 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) |
| Secondary | Number of Participants who achieve ≥20% body weight reduction | Baseline to 52 weeks | 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). |
| Secondary | Clinical global functioning as assessed by the Clinical Global Impressions Scale (CGI) score | Baseline to 52 weeks | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06847399
GET https://conductscience.org/api/trials/v1/NCT06847399/registered