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New treatment option for Obesity
Official title Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
ClinicalTrials.gov ID: NCT05975580
What this study is testing
What is Topiramate?
Topiramate is an investigational medicine, given as an once-daily, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male and female people 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...
You likely can't join if
- 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...
- History of significant (as determined by the investigator) and unstable cardiovascular disease including coronary artery disease, arrhythmias, severe...
- Use of monoamine oxidase inhibitors, current or within 2 weeks
See the full eligibility criteria
- Male and female people 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
- 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
- Epilepsy
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.