Clinical trial NCT02229214: Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
Official title: A Phase IV, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of VI-0521 on the Glomerular Filtration Rate of Healthy Overweight or Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Renal function
Glomerular Filtration Rate
Kidney function
Qsymia
Iohexol
Serum Creatinine
Creatinine clearance
Renal Clearance
VI-0521
Healthy volunteers
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2014-09-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Key Inclusion Criteria:

* Male or female 18 - 65 years of age, medically healthy with no clinically significant screening abnormalities
* BMI of ≥27 to ≤45 kg/m2
* No use of any medication (prescription, over the counter (OTC) or herbal preparations) with the exception of contraception for the entirety of the study

Key Exclusion Criteria:

* Allergy or hypersensitivity to radio contrast media, iodine or shellfish
* Plans to significantly alter their diet through fasting, very low caloric intake, elimination of certain foods (gluten, milk, meat, etc.) or similar
* Plans to undertake a significant change to physical exercise levels (i.e., initiate training for a marathon) during the study period
* Consumption of a high protein diet or protein/body building meal supplementation and/or replacement. The use of any product containing creatine is strictly prohibited
* History of glaucoma or increased intraocular pressure
* History of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression, current depression of moderate or greater severity, presence or history of suicidal behavior or ideation with some intent to act on it
* Cholelithiasis (gallstones) within the past 6 months
* History of nephrolithiasis (kidney stones)
* Evidence of any clinically significant renal, pulmonary, hepatic, psychiatric or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations or confound the interpretation of study results as determined by the investigator
* Current use of any tobacco products including cigarettes, cigars, pipes, and chewing tobacco, or nicotine replacement products (e.g., patch, gum, lozenge, etc.), or chronic use within the previous three months prior to screening

Primary outcomes:
measure: Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment
timeFrame: Baseline, end of treatment
measure: Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment
timeFrame: Baseline, 28 days after end of treatment
Secondary outcomes:
measure: Change in Serum Creatinine From Baseline to End of Treatment
timeFrame: Baseline, end of treatment
measure: Change in Serum Creatinine From Baseline to 28 Days After End of Treatment
timeFrame: Baseline, 28 days after end of treatment
measure: Change in Cystatin C From Baseline to End of Treatment
timeFrame: Baseline, end of treatment
measure: Change in Cystatin C From Baseline to 28 Days After End of Treatment
timeFrame: Baseline, 28 days after end of treatment
measure: Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment
timeFrame: Baseline, end of treatment
measure: Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment
timeFrame: Baseline, 28 days after end of treatment
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Research Center
state: Colorado
Study officials:
name: Chris Galloway, MD
role: PRINCIPAL_INVESTIGATOR
References: