Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

Official Title
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A Phase III Randomized, Double-Blind, Placebo Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions

Conditions
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Obesity, Type 2 Diabetes

Intervention / Treatment
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* Drug: VI-0521
* Drug: VI-0521
* Drug: VI-0521


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent BMI ≥ 27 (no lower BMI limit for Type 2 diabetics) 70 years of age or less Have 2 or more of the following obesity-related co-morbid conditions: Systolic blood pressure 140-160 mmHg (130-160 if diabetic); Diastolic blood pressure 90-100 mmHg (85-100 if diabetic); Requirement for 2 or more medications to achieve control (<140/90 mmHg) Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL) At lease one of the following metabolic criteria: Fasting blood glucose level > 100 mg/dL Glucose level > 140 mg/dL Diagnosis of type 2 diabetes Waist circumference ≥ 102 cm for men or ≥88 cm for women Exclusion Criteria: Stroke/MI/unstable cardiovascular disease within 6 months Clinically significant renal, hepatic or psychiatric disease Unstable thyroid disease or replacement therapy Nephrolithiasis Obesity of known genetic or endocrine origin Participation in a formal weight loss program or lifestyle intervention Glaucoma or intraocular pressure Pregnancy or breastfeeding Drug or Alcohol abuse Smoking cessation within previous 3 months or plans to quit smoking during study Eating disorders Cholelithiasis within past 6 months Excluded medications Type 1 diabetes or use of any antidiabetic medication other than metformin Previous bariatric surgery Bipolar disorder or psychosis Steroid hormone therapy Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg Creatinine clearance < 60 mL/minute

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VI-0521 Top<br>high dose experimental treatment | Drug: VI-0521<br>* phentermine 15 mg and topiramate 92 mg, po once daily<br>|
| Experimental: VI-0521 Mid<br>mid dose experimental treatment | Drug: VI-0521<br>* phentermine 7.5 mg and topiramate 46 mg, po once daily<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: VI-0521<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Loss From Baseline to Week 56 |  | Baseline to 56 weeks | 
| Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF |  | Baseline to 56 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Type 2 diabetes