CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Phentermine +3 moredrug
Likely dose
Placebo for Phentermine 8mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04095104
NCT04095104Phase 2Completed
CompareCT.gov

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

University of Colorado, Denver·interventional·Posted Sep 19, 2019·Updated May 23, 2025

In Brief

A Phase 2 clinical trial evaluating Phentermine, Immediate Release Topiramate, and 2 other interventions for Obesity, Morbid and 4 related conditions. Completed, enrolled 13 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Morbid, Bariatric Surgery, Adolescent, Young Adult, Drug Therapy
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado- Clinical and Translational Sciences Institute, University of Colorado- Nutrition Obesity Research Center

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 19, 2019
Enrollment StartJan 15, 2020
Primary CompletionJan 25, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.8 years ago

Interventions

Phenterminedrug

Phentermine tablet

Immediate Release Topiramatedrug

Topiramate tablet

Placebo for Phenterminedrug

Compounded tablet to mimic phentermine 8mg tablet

Placebo for Immediate Release Topiramatedrug

Compounded tablet to mimic immediate release topiramate 25mg tablet