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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229214
Recruitment Status : Completed
First Posted : September 1, 2014
Results First Posted : February 9, 2016
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Qsymia Drug: Placebo Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: VI-0521 (Qsymia)
  • 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)
Drug: Qsymia
Other Names:
  • VI-0521
  • Phentermine and Topiramate ER (Extended Release)

Placebo Comparator: Sugar pill
Days 1-28: Placebo
Drug: Placebo
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment [ Time Frame: Baseline, 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.


  2. Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment [ Time Frame: Baseline, 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



Secondary Outcome Measures :
  1. Change in Serum Creatinine From Baseline to End of Treatment [ Time Frame: Baseline, end of treatment ]
  2. Change in Serum Creatinine From Baseline to 28 Days After End of Treatment [ Time Frame: Baseline, 28 days after end of treatment ]
  3. Change in Cystatin C From Baseline to End of Treatment [ Time Frame: Baseline, end of treatment ]
  4. Change in Cystatin C From Baseline to 28 Days After End of Treatment [ Time Frame: Baseline, 28 days after end of treatment ]
  5. Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment [ Time Frame: Baseline, end of treatment ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229214


Locations
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United States, Colorado
Research Center
Lakewood, Colorado, United States, 80228
Sponsors and Collaborators
VIVUS, Inc.
Investigators
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Principal Investigator: Chris Galloway, MD

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Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT02229214    
Other Study ID Numbers: OB-404
First Posted: September 1, 2014    Key Record Dates
Results First Posted: February 9, 2016
Last Update Posted: November 7, 2017
Last Verified: October 2017
Keywords provided by VIVUS, Inc.:
Renal function
Glomerular Filtration Rate
Kidney function
Qsymia
Iohexol
Serum Creatinine
Creatinine clearance
Renal Clearance
VI-0521
Healthy volunteers
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
Topiramate
Phentermine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action