Loss-of-control EatingPhase 2/3NCT04599504
Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)
A Phase 2/3 study testing Lisdexamfetamine Dimesylate (Medication) in people with Loss-of-control Eating and Obesity/Overweight, run by Yale University at 1 site in United States.
Trial summary
This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Loss-of-control Eating, Obesity/Overweight
- What is being tested?
- Lisdexamfetamine Dimesylate (Medication)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2022to 4 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be in the age range ≥18 years of age and <65 years of age.
- Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
- Approximately ten months post-surgery
- Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment non-responders to a four-month treatment trial of medication and/or BWL
- Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).
- Read, comprehend, and write English at a sufficient level to complete study-related materials.
- Provide a signed and dated written informed consent prior to study participation.
- Be available for participation in the study for up to 15 months (3-month treatment plus 12-month follow up).
Who cannot join
- Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
- Has a history of anorexia nervosa or history of bulimia nervosa.
- Is currently using other medications for weight loss.
- Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
- Has untreated hypertension with a seated systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg, or heart rate > 100 beats/minute.
- Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
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- Has current uncontrolled hypertension.
- Has current uncontrolled Type I or Type II diabetes mellitus.
- Has untreated hypothyroidism with a TSH > 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit.
- Has gallbladder disease.
- Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder.
- Is currently in active treatment for eating or weight loss.
- Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
- Is breast-feeding or is pregnant or is not using a reliable form of birth control.
- Reports active suicidal or homicidal ideation.
- Previous history of problems with LDX or other stimulants.
- Has a history of allergy or sensitivity to LDX or other stimulant medications.
- Current medication contraindicated with study medication.
- Any current psychostimulant use or any medication for ADHD.
- History or current alcohol or substance use disorder (smoking will not be exclusionary)
- Is currently taking MAOI medication, SSRI medication, or strong inhibitors of CYP2D6
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06519
About this study
Official title: Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)
This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo.
- Conditions
- Loss-of-control Eating, Obesity/Overweight
- Being tested
- Lisdexamfetamine Dimesylate (Medication), Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisdexamfetamine Dimesylate (Medication)Drug
Also called Vyvanse
Medication will be taken daily in pill form.
PlaceboOther
Placebo will be inactive and taken daily in pill form.
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine dimesylate | Experimental | Not described Receives: Drug: Lisdexamfetamine Dimesylate (Medication) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss-of-Control Eating Frequency
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Measured: At the end of 12-week treatment
Loss-of-Control Eating Frequency
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Measured: 6-month follow-up from the end of treatment
Loss-of-Control Eating Frequency
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Measured: 12-month follow-up from the end of treatment
Percent Weight Change
Percent weight loss is calculated based on change from pre-treatment to post-treatment at 3 months. Negative values indicate weight loss.
Measured: From baseline at study enrollment to after the 12-week treatment
Percent Weight Change
Percent weight loss is calculated based on change from post-treatment to the 6-month follow-up. Negative values indicate weight loss.
Measured: From post-treatment to the 6-month follow-up
Percent Weight Change
Percent weight loss is calculated based on change from post-treatment to the 12-month follow-up. Negative values indicate weight loss.
Measured: From post-treatment to the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start2 Jan 2022
- Primary completion4 Jun 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Loss-of-control EatingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Grilo, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599504
- Sponsor's protocol ID
- 2000029057b
- Other IDs
- 5R01DK126637-02
- Status last verified
- Aug 2026
- First submitted
- 21 Oct 2020
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)
- ClinicalTrials.gov ID
- NCT04599504
- Acronym / sponsor ID
- 2000029057b
- Conditions
- Loss-of-control Eating, Obesity/Overweight
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 4 Jun 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine dimesylate | Experimental | Drug: Lisdexamfetamine Dimesylate (Medication) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be in the age range ≥18 years of age and <65 years of age.
- Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
- Approximately ten months post-surgery
- Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment non-responders to a four-month treatment trial of medication and/or BWL
- Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).
Key exclusion criteria (21 listed)
- Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
- Has a history of anorexia nervosa or history of bulimia nervosa.
- Is currently using other medications for weight loss.
- Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
- Has untreated hypertension with a seated systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg, or heart rate > 100 beats/minute.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lisdexamfetamine Dimesylate (Medication)Also: VyvanseMedication will be taken daily in pill form. | Drug | Lisdexamfetamine dimesylate |
| PlaceboPlacebo will be inactive and taken daily in pill form. | Other | Placebo |
Primary outcome
Loss-of-Control Eating Frequency
Time frame: At the end of 12-week treatment
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Loss-of-Control Eating Frequency
Time frame: 6-month follow-up from the end of treatment
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Loss-of-Control Eating Frequency
Time frame: 12-month follow-up from the end of treatment
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Percent Weight Change
Time frame: From baseline at study enrollment to after the 12-week treatment
Percent weight loss is calculated based on change from pre-treatment to post-treatment at 3 months. Negative values indicate weight loss.
Percent Weight Change
Time frame: From post-treatment to the 6-month follow-up
Percent weight loss is calculated based on change from post-treatment to the 6-month follow-up. Negative values indicate weight loss.
Percent Weight Change
Time frame: From post-treatment to the 12-month follow-up
Percent weight loss is calculated based on change from post-treatment to the 12-month follow-up. Negative values indicate weight loss.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Grilo, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lisdexamfetamine Dimesylate (Medication) in people with Loss-of-control Eating and Obesity/Overweight, run by Yale 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 8 inclusion and 21 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: finished, as of the sponsor's last update on 6 Aug 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss-of-Control Eating Frequency (time frame: At the end of 12-week treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.