NCT04095104

Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 12 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).

Conditions

• Obesity, Morbid
• Bariatric Surgery
• Adolescent
• Young Adult
• Drug Therapy

Interventions

Type	Name	Description
DRUG	Phentermine	Phentermine tablet
DRUG	Immediate Release Topiramate	Topiramate tablet
DRUG	Placebo for Phentermine	Compounded tablet to mimic phentermine 8mg tablet
DRUG	Placebo for Immediate Release Topiramate	Compounded tablet to mimic immediate release topiramate 25mg tablet

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-01-25
• Completion: 2022-01-25
• First posted: 2019-09-19
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study