Efficacy and Safety of IQP-VV-102 in Weight Management
Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-VV-102 in Reducing Body Weight in Overweight and Obese Subjects
1 other identifier
interventional
120
1 country
1
Brief Summary
Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started Oct 2012
Shorter than P25 for phase_3 obesity
1 active site
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
First Submitted
Initial submission to the registry
September 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
November 6, 2015
CompletedNovember 6, 2015
October 1, 2015
8 months
September 4, 2012
September 1, 2015
October 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Body Weight at End of Study Compared to Baseline
Change in body weight at the end of study compared to baseline
12 weeks
Secondary Outcomes (2)
Change in Waist Circumference (in cm) at End of Study From Baseline
12 weeks
Change in Mean Body Fat at End of Study From Baseline
12 weeks
Study Arms (2)
IQP-VV-102
ACTIVE COMPARATOR2 tablets twice a day
Placebo
PLACEBO COMPARATOR2 tablets twice a day
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 to 60 years
- kg/m2 ≤ BMI ≤ 35 kg/m2
- Written informed consent
You may not qualify if:
- Known sensitivity to sources of the active ingredients and excipients
- Pregnancy or nursing
- Inability to comply with study requirements, e.g. due to language difficulties
- Participation in another study during the last 30 days of the screening visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InQpharm Grouplead
Study Sites (1)
Barbara Grube
Berlin, State of Berlin, 10709, Germany
Related Publications (1)
Grube B, Bongartz U, Alt F. IQP-VV-102, a Novel Proprietary Composition for Weight Reduction: A Double-Blind Randomized Clinical Trial for Evaluation of Efficacy and Safety. Evid Based Complement Alternat Med. 2015;2015:413075. doi: 10.1155/2015/413075. Epub 2015 May 17.
PMID: 26074990DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Christof Jänicke
- Organization
- Analyze & Realize GmBH
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Grube, MD
Practice for General Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2012
First Posted
September 7, 2012
Study Start
October 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
November 6, 2015
Results First Posted
November 6, 2015
Record last verified: 2015-10