NCT05975580 · University of California, Irvine
Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
(PROJECT-BARI)
What this study is about
This is a randomly assigned controlled trial employing a Sequential Multiple Assignment randomly assigned Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Type 1 diabetes
- Insulin-dependent type 2 diabetes
- Fasting plasma glucose (FPG) ≥240 mg/dL
- 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
- Use of monoamine oxidase inhibitors, current or within 2 weeks
- Hyperthyroidism or other significant thyroid disease
- Angle-closure glaucoma
- Agitated states
- 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
- Serum triglycerides ≥500 mg/dL
- 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
- Use of antidepressant medication that has not been at stable dose for at least 3 months
- Hospital Anxiety and Depression Scale (HADS) score of ≥11 for depression or anxiety items
- Binge Eating Scale (BES) score of ≥27
- Alcohol use disorder within the past year
- 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
- History of revisional bariatric surgery (revisional surgery after adjustable gastric banding is acceptable)
- Currently participating in another weight loss program or have plans to participate in the next 13 months
- Smoking cessation within the previous 3 months or plans to quit smoking in the next 13 months
- Pregnant or breastfeeding or planning pregnancy in the coming 13 months
- 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
Where
- Orange, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 9, 2026 · Source of record for eligibility and locations