Medications plus lifestyle counseling to treat weight regain after bariatric surgery
Official title: Pharmacotherapy in conjunction with lifestyle counseling for management of weight regain after bariatric surgery (PROJECT-BARI)
Funded at University of California-Irvine · NIH-10897280 · Data updated 2026-11-12
This project compares two weight-loss medicines combined with diet and lifestyle counseling to help people who have regained weight after bariatric surgery lose weight.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of California-Irvine NIH-funded |
| Lab location | 1 site (Irvine, United States) |
| Project start | August 6, 2022 |
| Project end | July 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $693,106 |
| NIH project number | 5R01DK129936-04 |
| Project ID | NIH-10897280 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults who previously had bariatric surgery, have experienced meaningful weight regain, and are medically eligible to take phentermine or topiramate would be the ideal candidates.
✕Less likely to help
People who never had bariatric surgery, who have medical contraindications to the study drugs, or who prefer not to use medications are unlikely to benefit from this trial.
What this research studies
Many people regain weight after bariatric surgery, and this project offers medicines plus counseling to try to reverse that regain. 120 adults who have regained weight after bariatric surgery will be randomly assigned to take topiramate, phentermine, or placebo for the first four months while receiving diet and lifestyle counseling. Those who lose at least 5% by four months will continue the same treatment, while those who do not will be re-randomized to a higher dose or a combination pill for months 5–12. The trial is double-blind so neither participants nor study staff know who is receiving active medication versus placebo.
Why it matters
Potential benefit: If successful, this could become the first proven medication-based option to reverse weight regain after bariatric surgery and help reduce related health problems and improve quality of life.
How similar studies have gone: There are no published randomized controlled trials testing pharmacotherapy specifically to reverse weight regain after bariatric surgery, so this approach is largely untested in this population.
Where this research is happening
-
University of California-Irvine
Irvine, United States Active
Researchers
- Principal investigator: Gadde, Kishore M — University of California-Irvine
- Study coordinator: Gadde, Kishore M
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.