Can pills or counseling boost weight loss after surgery?
NCT ID NCT05157698
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding a combination of two drugs (naltrexone and bupropion) or a behavioral weight-loss program can help people who didn't lose enough weight after bariatric surgery. About 84 participants will receive either the drugs, behavioral therapy, both, or a placebo. The goal is to see if these extra treatments can improve weight loss, heart health, and overall well-being.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- naltrexone and bupropion combination pills
- What this could lead to
- If successful, this could provide a proven way to help people who haven't lost enough weight after bariatric surgery achieve better results.
- What could go wrong
- This is a small, early-stage trial with only 84 participants, so results may not apply to everyone. The medication can cause side effects like nausea or headache.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
84 people
The number who actually took part.
- Started
-
Jan 2022
- Expected to finish
-
Jan 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study (up to 18 months: 6-month treatment plus 12-month follow up) * Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2 * Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy * Suboptimal weight outcomes after MBS * Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies). * Have had a physical in the past year * Read, comprehend, and write English at a sufficient level to complete study-related materials. * For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner Exclusion Criteria: * 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 taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates). * Is currently using other medications for weight loss. * Has a history of allergy or sensitivity to bupropion or naltrexone. * 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. * Has current uncontrolled hypertension. * Has current uncontrolled Type I or Type 2 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. * Has a recent history of drug or alcohol dependence. * Is currently in active effective treatment for eating or weight loss such as behavioral weight loss of FDA-approved weight loss medications. * 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. * Has poor eye health
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Yale School of Medicine
New Haven, Connecticut, 06519, United States
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