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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229214
• Other study ID #: OB-404
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2014
• Last updated: October 6, 2017
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2017
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Qsymia

• Placebo

Locations

Country	Name	City	State
United States	Research Center	Lakewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, end of treatment
Primary	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	Baseline, 28 days after end of treatment
Secondary	Change in Serum Creatinine From Baseline to End of Treatment		Baseline, end of treatment
Secondary	Change in Serum Creatinine From Baseline to 28 Days After End of Treatment		Baseline, 28 days after end of treatment
Secondary	Change in Cystatin C From Baseline to End of Treatment		Baseline, end of treatment
Secondary	Change in Cystatin C From Baseline to 28 Days After End of Treatment		Baseline, 28 days after end of treatment
Secondary	Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment		Baseline, end of treatment
Secondary	Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment		Baseline, 28 days after end of treatment