CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled / 19 target
Drug / intervention
Phentermine / Topiramate Oral Product +1 moredrug
Likely dose
Phentermine / Topiramate Oral Product 37.5 mgfrom 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/NCT04621929
NCT04621929Phase 2CompletedUpdate Overdue (0.3/mo)Completion was 19mo ago
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Phentermine/tOpiramate to eND Obesity and Uric Acid Stones Trial (POuND OUT)

University of Florida·interventional·Posted Nov 9, 2020·Updated Jun 15, 2026

In Brief

A Phase 2 clinical trial evaluating Phentermine / Topiramate Oral Product and Citrate Salts, Allopurinol, Diet for Obesity and 3 related conditions. Completed, enrolled 19 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

The investigator proposes an 18 month, feasibility pilot study, randomizing obese and diabetic individuals with pure uric acid nephrolithiasis (UAN) or mixed calcium oxalate (CO) UAN to either phentermine/topiramate or a pragmatic control group who will remain on their standard medication regimen (citrate salts, allopurinol, diet, etc.).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Uric Acid Stones, Type 2 Diabetes Mellitus in Obese, Pre-Diabetes
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 9, 2020
Enrollment StartMar 31, 2021
Primary CompletionNov 14, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 5.6 years ago

Arms & Interventions

Allocated to intervention/treatmentexperimental

Daily phentermine/topiramate x 18 months

Drug: Phentermine / Topiramate Oral Product
Allocated to pragmatic controlactive_comparator

Remain on their current regimen

Combination Product: Citrate Salts, Allopurinol, Diet

Interventions

Phentermine / Topiramate Oral Productdrug

All participants in the experimental group will receive oral generic tablet phentermine (18.75 or 37.5 mg dose) and topiramate (daily 100 mg or 150 mg dose)

Citrate Salts, Allopurinol, Dietcombination

Control participants will complete initial visit requirements and study enrollment and will be maintained on their current therapy.