Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
Condition: Obesity
MeSH terms: Overweight
Intervention: Qsymia; Placebo
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Renal function; Glomerular Filtration Rate; Kidney function; Qsymia; Iohexol; Serum Creatinine; Creatinine clearance; Renal Clearance; VI-0521; Healthy volunteers

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