Could a Weight-Loss pill also crush kidney stones?
NCT ID NCT04621929
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested whether a combination of phentermine and topiramate, two drugs used for weight loss, could help shrink uric acid kidney stones in obese people with type 2 diabetes or pre-diabetes. Nineteen participants were randomly assigned to receive the drug combo or continue their usual care (citrate, allopurinol, diet). The main goal was to see if stone size changed over 18 months, along with weight, urine pH, and blood sugar levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Phentermine and topiramate (weight-loss drug combination)
- What this could lead to
- If it works, this could offer a way to treat both obesity and uric acid kidney stones with one medication, reducing the need for separate treatments.
- What could go wrong
- This was a very small pilot study with only 19 participants, so results may not apply to everyone. The drug combination can cause side effects like dizziness, tingling, and birth defects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
19 people
The number who actually took part.
- Started
-
Mar 2021
- Finished
-
Nov 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * have recurrent pure uric acid nephrolithiasis (UAN) or mixed calcium oxalate (CO)/UAN. Recurrent stone disease is defined as at least two spontaneous kidney stone passages, two previous kidney stone procedures, or one previous stone passage and one previous procedure. Pure UAN is defined as at least one previous stone analysis demonstrating 100% uric acid mineral content. Mixed COUAN will be defined as at least one previous stone analysis with any mix of uric acid ≥80% and ≤20% calcium oxalate. If participant has more than one stone analysis, the most recent will be considered the current stone type. * have obesity, defined as BMI \> 30 kg/m2. * 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. * have at least one 24-hour urine study off medications demonstrating urine pH \< 5.8 or a study 24-hr urine demonstrating urine pH \< 5.8 Exclusion Criteria: * 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Mixed calcium oxalate/uric acid nephrolithiasis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Florida
Gainesville, Florida, 32610, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which exercise dose best helps kids with metabolic syndrome?
- Custom knee guides put to the test in obese patients
- A pill for obesity? early human trial puts MDR-001 to the test
- Can a weekly shot help people who still struggle with weight after bariatric surgery?
- Do GLP-1 Weight-Loss drugs change how teens eat and feel?
- Can electrical muscle stimulation boost exercise benefits after menopause?