Trial Outcomes & Findings for Safety and Efficacy of IQP- AK-102 in Reducing Body Weight (NCT NCT01905956)

NCT ID: NCT01905956

Last Updated: 2016-03-08

Results Overview

Body weight (kg) was measured in subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA). Results were reported as value at baseline minus value at week-12, ie. amount of weight loss in (kg) (positive values).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

119 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2016-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	IQP-AK-102 2 capsules per dose, three times daily IQP-AK-102	Placebo 2 capsules per dose, 3 times daily Placebo
Overall Study STARTED	60	59
Overall Study Intention-to-treat Population	57	54
Overall Study COMPLETED	54	48
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of IQP- AK-102 in Reducing Body Weight

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IQP-AK-102 n=57 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=54 Participants 2 capsules per dose, 3 times daily Placebo	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=93 Participants	54 Participants n=4 Participants	111 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	47.9 years STANDARD_DEVIATION 12.3 • n=93 Participants	46.3 years STANDARD_DEVIATION 10.5 • n=4 Participants	47.4 years STANDARD_DEVIATION 11.4 • n=27 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	43 Participants n=4 Participants	83 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	11 Participants n=4 Participants	28 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	57 participants n=93 Participants	54 participants n=4 Participants	111 participants n=27 Participants
Region of Enrollment Germany	57 participants n=93 Participants	54 participants n=4 Participants	111 participants n=27 Participants
Height	169.3 centimetres (cm) STANDARD_DEVIATION 9.6 • n=93 Participants	168.2 centimetres (cm) STANDARD_DEVIATION 9.0 • n=4 Participants	168.8 centimetres (cm) STANDARD_DEVIATION 9.3 • n=27 Participants
Weight	83.0 kilogram (kg) STANDARD_DEVIATION 12.4 • n=93 Participants	80.8 kilogram (kg) STANDARD_DEVIATION 8.8 • n=4 Participants	81.9 kilogram (kg) STANDARD_DEVIATION 10.8 • n=27 Participants
Body Mass Index (BMI)	29.3 kilogram per metre square (kg/m^2) STANDARD_DEVIATION 2.7 • n=93 Participants	29.0 kilogram per metre square (kg/m^2) STANDARD_DEVIATION 2.1 • n=4 Participants	29.2 kilogram per metre square (kg/m^2) STANDARD_DEVIATION 2.4 • n=27 Participants
Waist Circumference	102.1 centimetres (cm) STANDARD_DEVIATION 10.8 • n=93 Participants	98.5 centimetres (cm) STANDARD_DEVIATION 6.9 • n=4 Participants	100.4 centimetres (cm) STANDARD_DEVIATION 9.2 • n=27 Participants
Hip Circumference	110.2 centimetres (cm) STANDARD_DEVIATION 8.3 • n=93 Participants	108.7 centimetres (cm) STANDARD_DEVIATION 7.8 • n=4 Participants	109.5 centimetres (cm) STANDARD_DEVIATION 8.1 • n=27 Participants
Systolic Blood Pressure	123.9 mmHg STANDARD_DEVIATION 9.2 • n=93 Participants	128.1 mmHg STANDARD_DEVIATION 15.7 • n=4 Participants	125.9 mmHg STANDARD_DEVIATION 12.9 • n=27 Participants
Diastolic Blood Pressure	79.7 mmHg STANDARD_DEVIATION 6.2 • n=93 Participants	81.3 mmHg STANDARD_DEVIATION 9.4 • n=4 Participants	80.5 mmHg STANDARD_DEVIATION 7.9 • n=27 Participants
Heart Rate	70.6 Beats per minute STANDARD_DEVIATION 5.3 • n=93 Participants	70.7 Beats per minute STANDARD_DEVIATION 5.5 • n=4 Participants	70.6 Beats per minute STANDARD_DEVIATION 5.4 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Outcome measures
Measure	IQP-AK-102 n=57 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=54 Participants 2 capsules per dose, 3 times daily Placebo
Mean Change in Body Weight From Baseline to Week 12	3.53 kilogram (kg) Standard Deviation 2.28	0.14 kilogram (kg) Standard Deviation 1.84

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Waist circumference (cm) was measured at the level midway between the lateral lower rib margin and the iliac crest. Hip circumference (cm) was measured as the maximal circumference over the buttocks. Results were reported as value at baseline minus value at week-12, ie. amount of waist and hip circumference reduction (cm) (positive values).

Outcome measures

Outcome measures
Measure	IQP-AK-102 n=57 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=54 Participants 2 capsules per dose, 3 times daily Placebo
Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 Waist Circumference	2.12 centimetre (cm) Standard Deviation 2.99	0.92 centimetre (cm) Standard Deviation 3.24
Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12 Hip Circumference	2.25 centimetre (cm) Standard Deviation 2.41	1.07 centimetre (cm) Standard Deviation 1.20

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.

Body fat content (%) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA). Results were reported as value at baseline minus value at week-12, ie. reduction of body fat content (%) (positive values).

Outcome measures

Outcome measures
Measure	IQP-AK-102 n=57 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=53 Participants 2 capsules per dose, 3 times daily Placebo
Mean Change in Body Fat Content (%) From Baseline to Week 12	0.95 Percentage of body fat (%) Standard Deviation 2.91	0.08 Percentage of body fat (%) Standard Deviation 1.90

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Body fat mass kg) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA). Results were reported as value at baseline minus value at week-12, ie. reduction of body fat mass kg) (positive values).

Outcome measures

Outcome measures
Measure	IQP-AK-102 n=57 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=53 Participants 2 capsules per dose, 3 times daily Placebo
Mean Change in Body Fat Mass (kg) From Baseline to Week 12	1.32 kilogram (kg) Standard Deviation 2.91	0.05 kilogram (kg) Standard Deviation 1.95

SECONDARY outcome

Timeframe: Baseline and 4, 8, and 12 weeks

Population: The analysis is performed for all subjects of the Intention-to-treat population who answered the FCQ at all visits from v2 to v5. Missing data were appeared in 9 cases at visit v5 and additional in 8 cases at visit v4.

This validated questionnaire evaluates changes in food cravings. It contains 15 items and was completed by the subjects based on the momentary feeling at the study site during visits 2 to 5 (Baseline and week 4, 8 and 12). Assessment was based on the following 5-point Likert scale: 1. = I do not agree at all 2. = I do not agree 3. = Neutral 4. = I agree 5. = I highly agree Results were expressed as the mean score for the whole population in the respective intervention group.

Outcome measures

Outcome measures
Measure	IQP-AK-102 n=52 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=47 Participants 2 capsules per dose, 3 times daily Placebo
Food Craving Questionnaire (FCQ) Baseline	2.65 Units on a scale Standard Deviation 1.28	2.74 Units on a scale Standard Deviation 1.07
Food Craving Questionnaire (FCQ) Week 4	2.17 Units on a scale Standard Deviation 0.94	2.47 Units on a scale Standard Deviation 1.04
Food Craving Questionnaire (FCQ) Week 8	1.98 Units on a scale Standard Deviation 0.96	2.34 Units on a scale Standard Deviation 0.92
Food Craving Questionnaire (FCQ) Week 12	2.31 Units on a scale Standard Deviation 1.08	2.47 Units on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.

Outcome measures

Outcome measures
Measure	IQP-AK-102 n=53 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=45 Participants 2 capsules per dose, 3 times daily Placebo
Global Evaluation of Efficacy by the Investigators Very Good	31 subjects	1 subjects
Global Evaluation of Efficacy by the Investigators Good	18 subjects	6 subjects
Global Evaluation of Efficacy by the Investigators Moderate	4 subjects	19 subjects
Global Evaluation of Efficacy by the Investigators Poor	0 subjects	19 subjects

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.

Outcome measures

Outcome measures
Measure	IQP-AK-102 n=54 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=44 Participants 2 capsules per dose, 3 times daily Placebo
Global Evaluation of Efficacy by the Subjects Very Good	28 subjects	1 subjects
Global Evaluation of Efficacy by the Subjects Good	22 subjects	6 subjects
Global Evaluation of Efficacy by the Subjects Moderate	4 subjects	22 subjects
Global Evaluation of Efficacy by the Subjects Poor	0 subjects	15 subjects

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.

Outcome measures

Outcome measures
Measure	IQP-AK-102 n=52 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=43 Participants 2 capsules per dose, 3 times daily Placebo
Global Evaluation of Safety by the Investigators Very Good	46 subjects	35 subjects
Global Evaluation of Safety by the Investigators Good	6 subjects	7 subjects
Global Evaluation of Safety by the Investigators Moderate	0 subjects	1 subjects
Global Evaluation of Safety by the Investigators Poor	0 subjects	0 subjects

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.

Outcome measures

Outcome measures
Measure	IQP-AK-102 n=53 Participants 2 capsules per dose, three times daily IQP-AK-102	Placebo n=45 Participants 2 capsules per dose, 3 times daily Placebo
Global Evaluation of Safety by the Subjects Poor	0 subjects	0 subjects
Global Evaluation of Safety by the Subjects Very Good	46 subjects	37 subjects
Global Evaluation of Safety by the Subjects Good	7 subjects	7 subjects
Global Evaluation of Safety by the Subjects Moderate	0 subjects	1 subjects

Adverse Events

IQP-AK-102

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IQP-AK-102 n=58 participants at risk 2 capsules per dose, three times daily IQP-AK-102	Placebo n=56 participants at risk 2 capsules per dose, 3 times daily Placebo
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	1.7% 1/58 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	0.00% 0/56 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.

Other adverse events

Other adverse events
Measure	IQP-AK-102 n=58 participants at risk 2 capsules per dose, three times daily IQP-AK-102	Placebo n=56 participants at risk 2 capsules per dose, 3 times daily Placebo
Respiratory, thoracic and mediastinal disorders Common cold or upper respiratory tract infection	10.3% 6/58 • Number of events 6 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	5.4% 3/56 • Number of events 4 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
General disorders Toothache or dental extraction	0.00% 0/58 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	3.6% 2/56 • Number of events 3 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Gastrointestinal disorders Gastrointestinal complaints	0.00% 0/58 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	1.8% 1/56 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
General disorders Headaches and Migraine	1.7% 1/58 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	3.6% 2/56 • Number of events 2 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
General disorders Distortion and contusion of knee	1.7% 1/58 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	1.8% 1/56 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	1.7% 1/58 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	0.00% 0/56 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Skin and subcutaneous tissue disorders Abcess of the skin	1.7% 1/58 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	0.00% 0/56 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Nervous system disorders Acute Sciatica (Dorsalgia)	0.00% 0/58 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	1.8% 1/56 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Eye disorders Macular degeneration	0.00% 0/58 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	1.8% 1/56 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Renal and urinary disorders Infection of urinary tract	0.00% 0/58 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	1.8% 1/56 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Gastrointestinal disorders Nausea & Vomiting	3.4% 2/58 • Number of events 2 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	0.00% 0/56 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Gastrointestinal disorders Flatulence	1.7% 1/58 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	0.00% 0/56 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.
Gastrointestinal disorders Constipation	1.7% 1/58 • Number of events 1 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.	0.00% 0/56 • During the treatment period ie. 12 weeks. The causality of the AEs and intake of IP was assessed by the clinician. Three subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.

Additional Information

Pee-Win Chong

InQpharm Europe Ltd

Phone: +603 6201 9690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place