Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
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
1 other identifier
interventional
2,487
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Nov 2007
Shorter than P25 for phase_3 obesity
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 3, 2007
CompletedFirst Posted
Study publicly available on registry
November 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
September 6, 2012
CompletedSeptember 10, 2012
September 1, 2012
1.6 years
November 3, 2007
July 31, 2012
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
VI-0521 Top
EXPERIMENTALhigh dose experimental treatment
VI-0521 Mid
EXPERIMENTALmid dose experimental treatment
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Informed Consent
- BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
- Medpace, Inc.collaborator
Study Sites (6)
Research Site
Birmingham, Alabama, 35294, United States
Research Site
Ridgefield, Connecticut, 06877, United States
Research Site
New York, New York, 10025, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Toledo, Ohio, 43623, United States
Research Site
Austin, Texas, 78731, United States
Related Publications (3)
Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28.
PMID: 28455281DERIVEDGarvey WT, Ryan DH, Bohannon NJ, Kushner RF, Rueger M, Dvorak RV, Troupin B. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.
PMID: 25249652DERIVEDGadde KM, Allison DB, Ryan DH, Peterson CA, Troupin B, Schwiers ML, Day WW. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Apr 16;377(9774):1341-52. doi: 10.1016/S0140-6736(11)60205-5. Epub 2011 Apr 8.
PMID: 21481449DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wesley W Day PhD
- Organization
- Vivus, Inc
Study Officials
- STUDY DIRECTOR
Craig Peterson
VIVUS LLC
- STUDY CHAIR
Kishore Gadde, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2007
First Posted
November 6, 2007
Study Start
November 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
September 10, 2012
Results First Posted
September 6, 2012
Record last verified: 2012-09