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

NCT02229214 | Completed Phase 4 Results

• 1 other identifier: OB-404
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Change in Serum Creatinine From Baseline to End of Treatment

  Baseline, end of treatment

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

  Baseline, 28 days after end of treatment

• Change in Cystatin C From Baseline to End of Treatment

  Baseline, end of treatment

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

  Baseline, 28 days after end of treatment

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

  Baseline, end of treatment

Study Arms (2)

VI-0521 (Qsymia)

EXPERIMENTAL

* 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

Sugar pill

PLACEBO COMPARATOR

Days 1-28: Placebo

Drug: Placebo

Interventions

Qsymia DRUG

Also known as: VI-0521, Phentermine and Topiramate ER (Extended Release)

VI-0521 (Qsymia)

Placebo DRUG

Also known as: Sugar Pill

Sugar pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VIVUS LLC: lead

Study Sites (1)

Research Center

Lakewood, Colorado, 80228, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Qsymia; Phentermine; Sugars

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Craig Peterson, Sr. Director, Clinical Research
• Organization: VIVUS Inc.

ClinicalTrials@vivus.com

650-934-5200

Study Officials

• Chris Galloway, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: September 1, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 7, 2017
• Results First Posted: February 9, 2016

Record last verified: 2017-10

Locations

US (1)