The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery.
This is a randomized, double-blind, placebo-controlled, single-site study in healthy overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and topiramate \[PHEN/TPM\] extended-release capsule) will be administered daily as follows: * Days 1-3: PHEN/TPM 3.75 mg /23 mg * Days 4-6: PHEN/TPM 7.5 mg /46 mg * Days 7-9: PHEN/TPM 11.25 mg /69 mg * Days 10-28: PHEN/TPM 15 mg /92 mg A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be administered intravenously on three separate occasions. The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom will have overnight stays on 3 separate occasions. Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4 weeks post treatment follow up).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
51
Research Center
Lakewood, Colorado, United States
Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment
Method that uses iohexol clearance and body surface area to measure kidney function. Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.
Time frame: Baseline, end of treatment
Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment
Method that uses iohexol clearance and body surface area to measure kidney function. Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR
Time frame: Baseline, 28 days after end of treatment
Change in Serum Creatinine From Baseline to End of Treatment
Time frame: Baseline, end of treatment
Change in Serum Creatinine From Baseline to 28 Days After End of Treatment
Time frame: Baseline, 28 days after end of treatment
Change in Cystatin C From Baseline to End of Treatment
Time frame: Baseline, end of treatment
Change in Cystatin C From Baseline to 28 Days After End of Treatment
Time frame: Baseline, 28 days after end of treatment
Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment
Time frame: Baseline, end of treatment
Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment
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Time frame: Baseline, 28 days after end of treatment