A Phase 2 interventional study of Tirzepatide and Lisdexamfetamine Dimesylate in Obesity and Overweight and Binge Eating Disorder, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
Among 104 studies testing tirzepatide in Obesity — 60 open to participants now, 79 under way, 14 of them phase 3. Tirzepatide · Obesity.
Among the 104 studies testing tirzepatide in Obesity, this one is the 48th largest by planned enrollment, is one of 34 that started in 2025, is one of 22 in phase 2, reaches primary completion later than 45 of the 78 other live ones, and was the 42nd registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →60 of the 104 studies testing tirzepatide in Obesity are open now, in 12 countries. Recruiting first, the newest first:
McMaster University · Sites in Canada
Ages 18–60
M.D. Anderson Cancer Center · Sites in United States
Ages 18–39
Eli Lilly and Company · Sites in United States, Belgium, Israel and 7 more countries
Ages 6–11
Eli Lilly and Company · Sites in United States
Ages 18–70
Columbia University · Sites in United States
Ages 40+
By country, each count listing its studies:
Tirzepatide: first FDA approval 2022 (MOUNJARO), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, tirzepatide is the treatment under test here. Read study by study →
104 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 24 · Phase 3 28 · Phase 4 29
First in 2019; this study’s year is marked. 34 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 105 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 69 across the 104 interventional studies. Of the 23 that completed or were terminated, 14 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
35 of 104 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
56 studies in Obesity by Johns Hopkins University: 8 open now, 12 under way, none of them phase 3. Of 42 finished, 18 (43%) have results posted.
Among the 56 studies in Obesity by Johns Hopkins University, this one is the 16th largest by planned enrollment of the 48 interventional ones that give a count, is one of 3 that started in 2025, is one of 5 in phase 2, reaches primary completion later than 6 of the 11 other live ones, and was the 54th registered.
Johns Hopkins University’s Obesity studies by the year they started, since 2006.
34 of the studies testing tirzepatide in Obesity that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07481747Phase 3Hudson BiotechEfficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1) | 2027-02-14 |
| NCT07738276Phase 3Shahid Beheshti University of Medical SciencesEvaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity | 2027-06-11 |
| NCT05556512Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity | 2027-10 |
Among the 104 studies testing tirzepatide in Obesity, from their registry updates:
Among Johns Hopkins University’s 56 in Obesity:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Disease Characteristics
Have a ≥30 kg/m2 or ≥27 kg/m2
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
Participants assigned female at birth: (participants assigned female at birth who are not of may participate and include those who are:
Participants assigned female at birth of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:
In the investigator's opinion, are well-motivated, capable, and willing to:
Exclusion Criteria:
Medical Conditions
Eating disorder-related
Current diagnosis of bulimia nervosa or anorexia nervosa
Diabetes-related
Have laboratory evidence diagnostic of diabetes mellitus during screening, including an ≥6.5% or fasting glucose >126 mg/dL
Obesity-related:
Other medical
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:
Prior/Concomitant Therapy
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
Prior/Concurrent Clinical Study Experience
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tirzepatide injection + placebo oral capsule
Drug: Tirzepatide · Behavioral: Guided self-help cognitive behavioral therapy · Drug: Placebo (oral)
Placebo injection + lisdexamfetamine dimesylate
Drug: Lisdexamfetamine Dimesylate · Behavioral: Guided self-help cognitive behavioral therapy · Drug: Placebo (injection)
Placebo injection + placebo oral capsule
Behavioral: Guided self-help cognitive behavioral therapy · Drug: Placebo (oral) · Drug: Placebo (injection)
Tirzepatide
Lisdexamfetamine dimesylate
Guided self-help cognitive behavioral therapy
Placebo (oral)
Placebo (injection)
Percent initial weight loss
To compare tirzepatide maximum tolerated dose (MTD) versus placebo from randomization to week 52 for percent initial weight loss
Time frame: 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
Time frame: Baseline to 52 weeks
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
Time frame: Baseline to 52 weeks
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
Time frame: Baseline to 52 weeks
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).
Time frame: Baseline to 52 weeks
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)
Time frame: Baseline to 52 weeks
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)
Time frame: Baseline to 52 weeks
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).
Time frame: Baseline to 52 weeks
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.
Time frame: Baseline to 52 weeks
Started Sep 2025 (actual). Primary completion is estimated for Dec 2027, 26 months after the start.
Of 132 non-industry phase 2 interventional studies under Obesity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 57. This study's planned 26 months is below that.
Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Tirzepatide