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

Primary Purpose

Obesity

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Qsymia

Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring Renal function, Glomerular Filtration Rate, Kidney function, Qsymia, Iohexol, Serum Creatinine, Creatinine clearance, Renal Clearance, VI-0521, Healthy volunteers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VI-0521 (Qsymia)

Sugar pill

Arm Description

Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg) Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg) Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg) Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)

Days 1-28: Placebo

Outcomes

Primary Outcome Measures

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.

Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment

Secondary Outcome Measures

Change in Serum Creatinine From Baseline to End of Treatment

Change in Serum Creatinine From Baseline to 28 Days After End of Treatment

Change in Cystatin C From Baseline to End of Treatment

Change in Cystatin C From Baseline to 28 Days After End of Treatment

Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment

Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment

Full Information

NCT ID

NCT02229214

First Posted

August 26, 2014

Last Updated

October 6, 2017

Sponsor

VIVUS LLC

1. Study Identification

Unique Protocol Identification Number

NCT02229214

Brief Title

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

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

August 2014 (Actual)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VIVUS LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Renal function, Glomerular Filtration Rate, Kidney function, Qsymia, Iohexol, Serum Creatinine, Creatinine clearance, Renal Clearance, VI-0521, Healthy volunteers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VI-0521 (Qsymia)

Arm Type

Experimental

Arm Description

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Description

Days 1-28: Placebo

Intervention Type

Drug

Intervention Name(s)

Qsymia

Other Intervention Name(s)

VI-0521, Phentermine and Topiramate ER (Extended Release)

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar Pill

Primary Outcome Measure Information:

Title

Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment

Description

Time Frame

Baseline, end of treatment

Title

Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment

Description

Time Frame

Baseline, 28 days after end of treatment

Secondary Outcome Measure Information:

Title

Change in Serum Creatinine From Baseline to End of Treatment

Time Frame

Baseline, end of treatment

Title

Change in Serum Creatinine From Baseline to 28 Days After End of Treatment

Time Frame

Baseline, 28 days after end of treatment

Title

Change in Cystatin C From Baseline to End of Treatment

Time Frame

Baseline, end of treatment

Title

Change in Cystatin C From Baseline to 28 Days After End of Treatment

Time Frame

Baseline, 28 days after end of treatment

Title

Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment

Time Frame

Baseline, end of treatment

Title

Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment

Time Frame

Baseline, 28 days after end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chris Galloway, MD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Center

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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