Phase 4 N=51 Randomized Triple-blind Treatment

Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02229214 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Feb 2016

Primary outcome: Primary: Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment — -14.92; 1.08 mL/min/1.73 m^2

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Qsymia (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VIVUS LLC
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment	-14.92; 1.08	—
PRIMARY Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment	-3.75; 2.34	—
SECONDARY Change in Serum Creatinine From Baseline to End of Treatment	0.10; 0.03	—
SECONDARY Change in Serum Creatinine From Baseline to 28 Days After End of Treatment	-0.01; 0.03	—
SECONDARY Change in Cystatin C From Baseline to End of Treatment	0.04; 0.03	—
SECONDARY Change in Cystatin C From Baseline to 28 Days After End of Treatment	0.01; 0.02	—
SECONDARY Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment	48.8; 0	—
SECONDARY Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment	7.3; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02229214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.