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Drug

Weight-Loss Drugs + Supplements for Uric Acid Kidney Stones

Phase 3
Waitlist Available
Led By Benjamin Canales, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have type 2 diabetes mellitus or pre-diabetes, defined as previously diagnosed by laboratory testing (hemoglobin A1c, fasting plasma glucose, or oral glucose tolerance test) or as demonstrated by use of anti-hyperglycemic medications or insulin.
Be older than 18 years old
Must not have
Contraindications to phentermine, including: unstable cardiovascular disease defined as decompensated heart failure, unstable angina, atrial fibrillation, uncontrolled blood pressure (>160 systolic), hyperthyroidism; monoamine oxidase inhibitor use; current history of drug or alcohol abuse.
Contraindications to topiramate, including: recurrent major depression, current substantial depressive symptoms, uncontrolled depression by PHQ 9 score >= 10, history of suicidal ideation or behavior with intent to act (versus exclude those with depression); current pregnancy or attempting to conceive; pre-existing chronic kidney disease with eGFR < 60 at time of enrollment; active cancer or active treatment for cancer (chemotherapy, radiation); and non-ambulatory.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial will test whether a weight-loss drug can help obese and diabetic people with kidney stones made of uric acid or a mix of uric acid and calcium.

Who is the study for?
This trial is for obese individuals with a BMI over 30 who have diabetes or prediabetes and recurrent uric acid kidney stones. They must not have unstable heart conditions, uncontrolled blood pressure, hyperthyroidism, severe depression, current drug/alcohol abuse, chronic kidney disease with eGFR < 60, active cancer treatment or be non-ambulatory.
What is being tested?
The study tests if phentermine/topiramate can help people with obesity and diabetes who get uric acid kidney stones. Participants are randomly chosen to either receive this medication combo or stick to their usual treatments like citrate salts and allopurinol for an 18-month period.
What are the potential side effects?
Phentermine may cause increased heart rate, dry mouth, restlessness while topiramate might lead to tingling in the hands/feet, weight loss, altered taste sensation. Both drugs together could potentially affect mood and energy levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes or pre-diabetes, diagnosed through tests or because I'm on medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have heart issues, uncontrolled high blood pressure, thyroid problems, or a history of substance abuse.
Select...
You are unable to participate if you have a history of recurring major depression, current significant depressive symptoms, or uncontrolled depression as indicated by a PHQ 9 score of 10 or higher. Additionally, if you are currently pregnant or trying to become pregnant, have pre-existing serious kidney disease, are undergoing active cancer treatment, or are unable to walk, you are not eligible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Kidney stone growth (mm2) as determined by non-contrast CT scan
New kidney stone formation (mm2) as determined by non-contrast CT scan
Secondary study objectives
Change in hemoglobin A1c
Change in urinary calcium parameters
Change in urinary citrate parameters
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Allocated to intervention/treatmentExperimental Treatment1 Intervention
Daily phentermine/topiramate x 18 months
Group II: Allocated to pragmatic controlActive Control1 Intervention
Remain on their current regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phentermine
FDA approved

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,201 Total Patients Enrolled
38 Trials studying Obesity
20,391 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,431 Total Patients Enrolled
472 Trials studying Obesity
590,992 Patients Enrolled for Obesity
Benjamin Canales, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Allopurinol (Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04621929 — Phase 3
Obesity Research Study Groups: Allocated to intervention/treatment, Allocated to pragmatic control
Obesity Clinical Trial 2023: Allopurinol Highlights & Side Effects. Trial Name: NCT04621929 — Phase 3
Allopurinol (Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04621929 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT04621929 — Phase 3
~5 spots leftby Jan 2026
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