Medicines With Lifestyle Counseling for Weight Regain After Bariatric Surgery

Trial details

Who runs it

University of California, Irvine

Trial code

NCT05975580

Record updated

19 October 2026

Original description

This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.Read full original descriptionShow less

Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery

This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.

Inclusion: Male and female subjects aged 18-70 years; Had sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) at least 18 months ago; Weight regain of ≥5% relative to post-surgery nadir weight; Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with weight-related comorbidities; Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry; Must be able to provide written informed consent.

Exclusion: Use of monoamine oxidase inhibitors, current or within 2 weeks; Use of antidepressant medication that has not been at stable dose for at least 3 months; Currently taking phentermine or topiramate or the combination, or products containing these drugs; Currently taking stimulants (e.g., Attention Deficit Hyperactivity Disorder medications); Current use of prescription or over-the-counter weight loss drugs or supplements; Taking prescription or over-the-counter drugs or products, which in the opinion of the PI, could be associated with significant effects on body weight; Planning additional bariatric surgery procedures in the next 13 months; Smoking cessation within the previous 3 months or plans to quit smoking in the next 13 months; Type 1 diabetes; Insulin-dependent type 2 diabetes; Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥100 mm Hg on the average of three seated measurements after being at rest for at least 5 minutes; History of significant (as determined by the investigator) and unstable cardiovascular disease including coronary artery disease, arrhythmias, severe congestive heart failure, or stroke; Hyperthyroidism or other significant thyroid disease; History of drug abuse within the past year; Known hypersensitivity or idiosyncrasy to sympathomimetic amines; Severe hepatic disease (non-alcoholic fatty liver disease or non-alcoholic steatohepatitis without portal hypertension or cirrhosis is acceptable); End-stage renal disease; History of nephrolithiasis; Cancer, not in remission, within the past 2 years except for adequately treated basal cell, squamous cell skin cancer, or in-situ cervical cancer; History of psychosis or bipolar disorder; Suicidal ideation or unstable/untreated major depressive disorder within the past year; Alcohol use disorder within the past year; Epilepsy; History of revisional bariatric surgery (revisional surgery after adjustable gastric banding is acceptable); History of, or any existing condition that, in the opinion of the Principal Investigator, would interfere with the study outcomes or place the subject at unacceptable risk by participating in the study; Fasting plasma glucose (FPG) ≥240 mg/dL; Serum triglycerides ≥500 mg/dL; Angle-closure glaucoma; Agitated states; Hospital Anxiety and Depression Scale (HADS) score of ≥11 for depression or anxiety items; Binge Eating Scale (BES) score of ≥27; Currently participating in another weight loss program or have plans to participate in the next 13 months; Pregnant or breastfeeding or planning pregnancy in the coming 13 months.

ClinicalTrials.gov NCT05975580