Pharmacotherapy for Weight Regain After Bariatric Surgery

This study is looking at whether certain medications, along with healthy lifestyle advice, can help people who have regained weight after bariatric (weight loss) surgery. Researchers are testing two drugs, Topiramate and Phentermine, and a combination of both, against a placebo (an inactive substance). You might be able to join if you are between 18 and 70 years old, had sleeve gastrectomy or Roux-en-Y gastric bypass at least 18 months ago, and have regained at least 5% of your lowest weight after surgery. The main goal is to see if these medications lead to greater weight loss after 12 months compared to the placebo. The study is currently unclear on its recruitment status.

Study design
This is a randomized controlled trial with 120 participants. Participants will be initially assigned to receive Topiramate, Phentermine, or a placebo, and some may be re-assigned to different treatments later in the study.
What's involved
You would receive daily treatment with a study drug or placebo and participate in diet and lifestyle counseling throughout the 12-month study period. Weight loss will be measured at the beginning and at Month 12.
Compensation
Not stated in the trial record.
Follow-up
Your weight loss will be measured at Month 12, which is the end of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05975580

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

Recruiting
PHASE4Ages 18–70InterventionalTreatment
University of California, Irvine
~120 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:TopiramatePhenterminePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent weight loss at Month 12 - Topiramate vs placebo
Measured over Month 0, Month 12
+2 more outcomes measured
Obesity
1 sites across 1 states
California1
  • Kishore M Gadde, MD · PRINCIPAL_INVESTIGATOR · University of California, Irvine

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  • Percent weight loss at Month 12 - Topiramate vs placeboMonth 0, Month 12

    Topiramate (Group 1 \[Group A + Group B\]) vs placebo (Group P)

  • Percent weight loss at Month 12 - Phentermine vs placeboMonth 0, Month 12

    Phentermine (Group 2 \[Group D + Group E) vs placebo (Group P)

  • Percent weight loss at Month 12 - Phentermine/TopiramateMonth 0, Month 12

    Phentermine/Topiramate (Group 3 \[Group C + Group F\]) vs placebo (Group P)