Trial Outcomes & Findings for Efficacy and Safety of IQP-VV-102 in Weight Management (NCT NCT01681069)

NCT ID: NCT01681069

Last Updated: 2015-11-06

Results Overview

Change in body weight at the end of study compared to baseline

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 120 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2015-11-06

Participant Flow

Participant milestones

Measure	IQP-VV-102 2 tablets twice a day IQP-VV-102	Placebo 2 tablets twice a day Placebo
Overall Study STARTED	60	60
Overall Study Full Analysis Set (FAS)	57	60
Overall Study COMPLETED	55	53
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	IQP-VV-102 2 tablets twice a day IQP-VV-102	Placebo 2 tablets twice a day Placebo
Overall Study Withdrawal by Subject	4	5
Overall Study Protocol Violation	1	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Efficacy and Safety of IQP-VV-102 in Weight Management

Baseline characteristics by cohort

Measure	IQP-VV-102 n=57 Participants 2 tablets twice a day IQP-VV-102	Placebo n=60 Participants 2 tablets twice a day Placebo	Total n=117 Participants Total of all reporting groups
Age, Continuous	43.6 year STANDARD_DEVIATION 11.6 • n=5 Participants	40.5 year STANDARD_DEVIATION 11.9 • n=7 Participants	42.0 year STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	38 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	22 Participants n=7 Participants	34 Participants n=5 Participants
Body Weight	82.0 kg STANDARD_DEVIATION 10.6 • n=5 Participants	84.9 kg STANDARD_DEVIATION 12.9 • n=7 Participants	83.5 kg STANDARD_DEVIATION 11.9 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Change in body weight at the end of study compared to baseline

Outcome measures

Measure	IQP-VV-102 n=57 Participants 2 tablets twice a day IQP-VV-102	Placebo n=60 Participants 2 tablets twice a day Placebo
Change in Body Weight at End of Study Compared to Baseline	3.29 kg Standard Deviation 2.30	0.83 kg Standard Deviation 2.00

SECONDARY outcome

Timeframe: 12 weeks

Difference in waist circumference (in cm) at end of study from baseline

Outcome measures

Measure	IQP-VV-102 n=57 Participants 2 tablets twice a day IQP-VV-102	Placebo n=60 Participants 2 tablets twice a day Placebo
Change in Waist Circumference (in cm) at End of Study From Baseline	2.11 cm Standard Deviation 2.09	0.81 cm Standard Deviation 2.02

SECONDARY outcome

Timeframe: 12 weeks

Measured in kg using calibrated weighing scales

Outcome measures

Measure	IQP-VV-102 n=57 Participants 2 tablets twice a day IQP-VV-102	Placebo n=60 Participants 2 tablets twice a day Placebo
Change in Mean Body Fat at End of Study From Baseline	2.14 kg Standard Deviation 3.42	0.56 kg Standard Deviation 2.43

Adverse Events

IQP-VV-102

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IQP-VV-102 n=57 participants at risk 2 tablets twice a day IQP-VV-102	Placebo n=60 participants at risk 2 tablets twice a day Placebo
Renal and urinary disorders Urinary Tract Infection	3.5% 2/57 • Number of events 2 • 12 weeks All adverse effect reported were not deemed associated with the investigational product	0.00% 0/60 • 12 weeks All adverse effect reported were not deemed associated with the investigational product
Respiratory, thoracic and mediastinal disorders Respiratory infections	1.8% 1/57 • Number of events 1 • 12 weeks All adverse effect reported were not deemed associated with the investigational product	5.0% 3/60 • Number of events 3 • 12 weeks All adverse effect reported were not deemed associated with the investigational product
Gastrointestinal disorders Vomitting and diarhoea	1.8% 1/57 • Number of events 1 • 12 weeks All adverse effect reported were not deemed associated with the investigational product	1.7% 1/60 • Number of events 1 • 12 weeks All adverse effect reported were not deemed associated with the investigational product
Endocrine disorders Hypothyrodism	1.8% 1/57 • 12 weeks All adverse effect reported were not deemed associated with the investigational product	0.00% 0/60 • 12 weeks All adverse effect reported were not deemed associated with the investigational product
General disorders Headache	0.00% 0/57 • 12 weeks All adverse effect reported were not deemed associated with the investigational product	5.0% 3/60 • 12 weeks All adverse effect reported were not deemed associated with the investigational product
General disorders Bruised left thigh	0.00% 0/57 • 12 weeks All adverse effect reported were not deemed associated with the investigational product	1.7% 1/60 • 12 weeks All adverse effect reported were not deemed associated with the investigational product

Additional Information

Dr Christof Jänicke

Analyze & Realize GmBH

Phone: +49 30 40 00 83 23

Email: cj@a-r.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER