Trial Outcomes & Findings for Efficacy and Safety of Zenoctil in Reducing Body Weight (NCT NCT01423617)

NCT ID: NCT01423617

Last Updated: 2015-04-23

Results Overview

Change in mean body weight at week 12 compared to baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 92 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2015-04-23

Participant Flow

Participant milestones

Measure	Zenoctil Zenoctil: 3 tablets 2 times daily	Placebo Placebo: 3 tablets 2 times daily
Overall Study STARTED	46	46
Overall Study COMPLETED	46	45
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Zenoctil Zenoctil: 3 tablets 2 times daily	Placebo Placebo: 3 tablets 2 times daily
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Efficacy and Safety of Zenoctil in Reducing Body Weight

Baseline characteristics by cohort

Measure	Zenoctil n=46 Participants Zenoctil: 3 tablets 2 times daily	Placebo n=45 Participants Placebo: 3 tablets 2 times daily	Total n=91 Participants Total of all reporting groups
Age, Continuous	43.1 years STANDARD_DEVIATION 10.9 • n=5 Participants	42.5 years STANDARD_DEVIATION 11.6 • n=7 Participants	42.8 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Change in mean body weight at week 12 compared to baseline.

Outcome measures

Measure	Zenoctil n=46 Participants Zenoctil: 3 tablets 2 times daily	Placebo n=45 Participants Placebo: 3 tablets 2 times daily
Change in Mean Body Weight (kg)	-2.26 kg Standard Deviation 2.37	-0.56 kg Standard Deviation 2.45

PRIMARY outcome

Timeframe: 12 weeks

Change in mean body fat at week 12 compared to baseline

Outcome measures

Measure	Zenoctil n=46 Participants Zenoctil: 3 tablets 2 times daily	Placebo n=45 Participants Placebo: 3 tablets 2 times daily
Change in Mean Body Fat (kg)	-1.12 kg Standard Deviation 1.84	0.37 kg Standard Deviation 2.14

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Zenoctil n=46 Participants Zenoctil: 3 tablets 2 times daily	Placebo n=45 Participants Placebo: 3 tablets 2 times daily
Number of Subjects Who Lost at Least 3% of Baseline Body Weight	24 participants	8 participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Zenoctil n=46 Participants Zenoctil: 3 tablets 2 times daily	Placebo n=45 Participants Placebo: 3 tablets 2 times daily
Changes in Waist Circumference (cm)	-2.00 cm Standard Deviation 2.44	-0.69 cm Standard Deviation 2.24

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Zenoctil n=46 Participants Zenoctil: 3 tablets 2 times daily	Placebo n=45 Participants Placebo: 3 tablets 2 times daily
Changes in Hip Circumference	-1.54 cm Standard Deviation 1.76	0.64 cm Standard Deviation 1.91

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Subject's feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = "no"; 1 = "slightly", 2 = "moderate" and 3 = "strong".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

The investigators evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

The subjects evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".

Outcome measures

Outcome data not reported

Adverse Events

Zenoctil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Christof Jänicke

Analyze & Realize

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