The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity

A Randomized, Double-blind, Placebo-controlled Study of Effects of Two Fixed-dose Leucine-sildenafil Combinations (NS-0300) or Two Fixed-dose Leucine-sildenafil-metformin Combinations (NS-0200) Versus Placebo on Body Weight in Obesity

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03364335

Enrollment

267

Registered

2017-12-06

Start date

2018-01-08

Completion date

2018-08-17

Last updated

2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

This is a 24-week study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. The primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24).

Detailed description

This is a randomized, 24-week, placebo-controlled, double-blind study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Subjects meeting all the inclusion criteria and no exclusion criteria will be randomized to one of five study arms. The primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24) receiving two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Secondary objectives will also assess changes in absolute body weight, percentage of patients with ≥5% body weight loss, change in waist circumference, change in HbA1c, change in fasting glucose, change in blood lipids such as cholesterol, LDL, HDL, triglycerides, change in blood pressure and changes in in C-reactive protein. In addition this study will evaluate the safety and tolerability of NS-0200 and NS-0300. Patients will have one screening visits which will determine their eligibility based on lab tests. Once qualified, patients will be randomly assigned to either one of the treatment groups or the placebo control group and monitored for a total of 24 weeks. Patients will return to the clinic each month for lab tests, and routine examinations.

Interventions

DRUGLeu Sil 1.0mg

Leu 1100 mg + 1mg Sil BID

DRUGLeu Sil 4.0mg

Leu 1100 mg + 4mg Sil BID

DRUGLeu Met Sil 1.0mg

Leu 1100 mg + Met 500mg + 1mg Sil BID

DRUGLeu Met Sil 4.0mg

Leu 1100 mg + Met 500mg + 4mg Sil BID

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

This is a double blind, placebo controlled trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Age ≥18 and ≤65 at study entry. 2. Is male, or female and, if female, meets all of the following criteria: 1. Not breastfeeding 2. Post-menopausal or negative serum pregnancy test result (human chorionic gonadotropin, beta subunit \[β-hCG\]) at Screening/Visit 1 (Day-7/Week-1) (not required for hysterectomized females) 3. If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods \[male condom with spermicide, with or without cervical cap or diaphragm\], implants, injectables, oral contraceptives \[must have been using for at least the last 3 months\], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized or same sex partner) during the entire duration of the study 3. Stable body weight (±5%) and health over the last 3 months. 4. Has a BMI between 30 kg/m2 and 45 kg/m2 5. Stable diet within the last three months 6. Subjects on antidepressants, excluding those listed in the

Exclusion criteria

, must have been on a stable dose regiment for at least 3 months prior to study enrollment and maintain stable dose during the study 7. Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) either normal, not clinically significant or with abnormalities consistent with obesity 8. Is able to read, understand, and sign the informed consent forms (ICF) and, when applicable, an authorization to use and disclose protected health information form (consistent with Health Insurance Portability and Accountability Act of 1996 \[HIPAA\] legislation), communicate with the investigator, and understand and comply with protocol requirements.

Design outcomes

Primary

Measure	Time frame	Description
Percentage Body Weight Change	Baseline to Day 168	The percentage body weight change from baseline to Day 168 was evaluated.

Secondary

Measure	Time frame	Description
Change in Systolic Blood Pressure	Baseline, Day 168	Change in Systolic blood pressure was assessed in patients from baseline to Day 168
Change in Absolute Body Weight	Baseline to Day 168	The change in absolute body weight from baseline to day 168 was evaluated.
Change in Percentage of Patients With ≥5% Body Weight Loss	Baseline to Day 168	The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168.
Change in Waist Circumference	Baseline to Day 168	The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168.
Change in Total Cholesterol	Baseline to Day 168	Changes in total cholesterol was examined by standard blood chemistry.
Change in Diastolic Blood Pressure	Baseline to Day 168	Diastolic blood pressure was measured by standard blood pressure monitor.
Change in LDL Cholesterol	Baseline, 168 days	Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.
Change in Triglycerides	Baseline, Day 168	The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.
Change in Plasma Glucose	Baseline to Day 168	Change in plasma glucose was examined through standard fasting blood chemistry.
Change in Hemoglobin A1c (HbA1c)	Baseline, Day 168	Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.
Change in Inflammatory Markers	Baseline to Day 168	hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry.
Change in HDL Cholesterol	Baseline, Day 168	Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.

Countries

United States

Participant flow

Recruitment details

Subjects meeting all inclusion criteria and no exclusion criteria were randomized to one of five treatment arms in the ratio of 1:1:1:1:1(A:B:C:D:E). The randomization was stratified by a maximum of 70% female with a BMI range between 30 kg/m2 and 45 kg/m2

Pre-assignment details

The discrepancy in the number of enrolled subjects and the actual number that started the study is because some of the enrolled subjects did not start the study for the following reasons: they moved, were not compliant with investigator request or were sent on active military duty.

Participants by arm

Arm	Count
Placebo Placebo: Placebo	52
Leu Sil 1.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	51
Leu Sil 4.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	53
Leu Met Sil 1.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	50
Leu Met Sil 4.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID	52
Total	258

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004
Overall Study	Adverse Event	3	4	1	2	0
Overall Study	Lost to Follow-up	7	7	10	11	11

Baseline characteristics

Characteristic	Placebo	Leu Sil 1.0mg	Leu Sil 4.0mg	Leu Met Sil 1.0mg	Leu Met Sil 4.0mg	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	52 Participants	51 Participants	53 Participants	50 Participants	52 Participants	258 Participants
Age, Continuous	41.29 years STANDARD_DEVIATION 11.3	40.94 years STANDARD_DEVIATION 11.14	39.55 years STANDARD_DEVIATION 11.14	41.36 years STANDARD_DEVIATION 12.66	42.89 years STANDARD_DEVIATION 10.7	41.20 years STANDARD_DEVIATION 11.36
Body Mass Index (BMI)	35.773 kg/m^2 STANDARD_DEVIATION 3.31	37.179 kg/m^2 STANDARD_DEVIATION 4.28	37.9 kg/m^2 STANDARD_DEVIATION 4.2	36.425 kg/m^2 STANDARD_DEVIATION 4.13	37.152 kg/m^2 STANDARD_DEVIATION 4.23	36.89 kg/m^2 STANDARD_DEVIATION 4.08
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants	12 Participants	13 Participants	12 Participants	15 Participants	60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants	39 Participants	40 Participants	38 Participants	37 Participants	198 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	4 Participants
Race (NIH/OMB) Black or African American	9 Participants	9 Participants	13 Participants	11 Participants	11 Participants	53 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) White	40 Participants	42 Participants	39 Participants	37 Participants	40 Participants	198 Participants
Sex: Female, Male Female	38 Participants	29 Participants	32 Participants	39 Participants	35 Participants	173 Participants
Sex: Female, Male Male	14 Participants	22 Participants	21 Participants	11 Participants	17 Participants	85 Participants
Waist Circumference	110.40 cm STANDARD_DEVIATION 10.998	112.91 cm STANDARD_DEVIATION 11.466	116.02 cm STANDARD_DEVIATION 12.411	111.17 cm STANDARD_DEVIATION 13.291	112.93 cm STANDARD_DEVIATION 13.311	112.71 cm STANDARD_DEVIATION 12.39
Weight (kg)	101.67 kg STANDARD_DEVIATION 13.856	105.05 kg STANDARD_DEVIATION 15.568	107.16 kg STANDARD_DEVIATION 17.962	100.18 kg STANDARD_DEVIATION 16.991	104.50 kg STANDARD_DEVIATION 17.405	103.74 kg STANDARD_DEVIATION 16.49

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 52	0 / 51	0 / 53	0 / 50	0 / 52
other Total, other adverse events	14 / 52	19 / 51	12 / 53	21 / 50	19 / 52
serious Total, serious adverse events	0 / 52	2 / 51	0 / 53	1 / 50	0 / 52

Outcome results

Primary

Percentage Body Weight Change

The percentage body weight change from baseline to Day 168 was evaluated.

Time frame: Baseline to Day 168

Population: ANCOVA Analysis for Primary Endpoint - Percent Change in Body Weight from Baseline to Day 168 in per protocol population.

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Percentage Body Weight Change	1.121 percentage	Standard Deviation 3.6241
Leu Sil 1.0mg	Percentage Body Weight Change	0.674 percentage	Standard Deviation 3.2286
Leu Sil 4.0mg	Percentage Body Weight Change	-0.489 percentage	Standard Deviation 3.9041
Leu Met Sil 1.0mg	Percentage Body Weight Change	-0.929 percentage	Standard Deviation 4.5533
Leu Met Sil 4.0mg	Percentage Body Weight Change	-0.552 percentage	Standard Deviation 2.5924

p-value: 0.5461ANCOVA

p-value: 0.0364ANCOVA

p-value: 0.0156ANCOVA

p-value: 0.0349ANCOVA

Secondary

Change in Absolute Body Weight

The change in absolute body weight from baseline to day 168 was evaluated.

Time frame: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Absolute Body Weight from Baseline to day 168 (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in Absolute Body Weight	1.126 kg	Standard Deviation 3.5903
Leu Sil 1.0mg	Change in Absolute Body Weight	0.678 kg	Standard Deviation 3.2502
Leu Sil 4.0mg	Change in Absolute Body Weight	-0.460 kg	Standard Deviation 4.0352
Leu Met Sil 1.0mg	Change in Absolute Body Weight	-0.870 kg	Standard Deviation 4.5445
Leu Met Sil 4.0mg	Change in Absolute Body Weight	-0.461 kg	Standard Deviation 2.7583

p-value: 0.5348ANCOVA

p-value: 0.0379ANCOVA

p-value: 0.0215ANCOVA

p-value: 0.0464ANCOVA

Secondary

Change in Diastolic Blood Pressure

Diastolic blood pressure was measured by standard blood pressure monitor.

Time frame: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population)

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in Diastolic Blood Pressure	-1.7 mmHg	Standard Deviation 7.13
Leu Sil 1.0mg	Change in Diastolic Blood Pressure	1.8 mmHg	Standard Deviation 9.57
Leu Sil 4.0mg	Change in Diastolic Blood Pressure	-2.6 mmHg	Standard Deviation 8.1
Leu Met Sil 1.0mg	Change in Diastolic Blood Pressure	1.1 mmHg	Standard Deviation 9.16
Leu Met Sil 4.0mg	Change in Diastolic Blood Pressure	-3.3 mmHg	Standard Deviation 7.48

p-value: 0.0524ANCOVA

p-value: 0.5221ANCOVA

p-value: 0.3702ANCOVA

p-value: 0.5426ANCOVA

Secondary

Change in HDL Cholesterol

Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.

Time frame: Baseline, Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in HDL Cholesterol	1.1 mg/dL	Standard Deviation 7.43
Leu Sil 1.0mg	Change in HDL Cholesterol	0.6 mg/dL	Standard Deviation 7.59
Leu Sil 4.0mg	Change in HDL Cholesterol	2.4 mg/dL	Standard Deviation 6.4
Leu Met Sil 1.0mg	Change in HDL Cholesterol	1.8 mg/dL	Standard Deviation 8.21
Leu Met Sil 4.0mg	Change in HDL Cholesterol	1.6 mg/dL	Standard Deviation 7.72

p-value: 0.4644ANCOVA

p-value: 0.8573ANCOVA

p-value: 0.8167ANCOVA

p-value: 0.9223ANCOVA

Secondary

Change in Hemoglobin A1c (HbA1c)

Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.

Time frame: Baseline, Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in HbA1c from Baseline to day 168 (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in Hemoglobin A1c (HbA1c)	0.16 percentage of glycosylated hemoglobin	Standard Deviation 0.164
Leu Sil 1.0mg	Change in Hemoglobin A1c (HbA1c)	0.09 percentage of glycosylated hemoglobin	Standard Deviation 0.167
Leu Sil 4.0mg	Change in Hemoglobin A1c (HbA1c)	0.11 percentage of glycosylated hemoglobin	Standard Deviation 0.165
Leu Met Sil 1.0mg	Change in Hemoglobin A1c (HbA1c)	0.07 percentage of glycosylated hemoglobin	Standard Deviation 0.198
Leu Met Sil 4.0mg	Change in Hemoglobin A1c (HbA1c)	0.09 percentage of glycosylated hemoglobin	Standard Deviation 0.177

p-value: 0.1653ANCOVA

p-value: 0.197ANCOVA

p-value: 0.0608ANCOVA

p-value: 0.1583ANCOVA

Secondary

Change in Inflammatory Markers

hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry.

Time frame: Baseline to Day 168

Population: Descriptive Statistics for Secondary Endpoint - hs-C-Reactive Protein Change from Baseline to day 168 (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in Inflammatory Markers	0.90 mg/L	Standard Deviation 2.401
Leu Sil 1.0mg	Change in Inflammatory Markers	0.12 mg/L	Standard Deviation 3.633
Leu Sil 4.0mg	Change in Inflammatory Markers	0.35 mg/L	Standard Deviation 3.385
Leu Met Sil 1.0mg	Change in Inflammatory Markers	0.56 mg/L	Standard Deviation 6.624
Leu Met Sil 4.0mg	Change in Inflammatory Markers	0.12 mg/L	Standard Deviation 3.551

p-value: 0.0318ANCOVA

p-value: 0.3827ANCOVA

p-value: 0.005ANCOVA

p-value: 0.1045ANCOVA

Secondary

Change in LDL Cholesterol

Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.

Time frame: Baseline, 168 days

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in LDL Cholesterol	-5.5 mg/dL	Standard Deviation 15.4
Leu Sil 1.0mg	Change in LDL Cholesterol	-6.6 mg/dL	Standard Deviation 16.86
Leu Sil 4.0mg	Change in LDL Cholesterol	-4.2 mg/dL	Standard Deviation 15.81
Leu Met Sil 1.0mg	Change in LDL Cholesterol	-5.5 mg/dL	Standard Deviation 11.77
Leu Met Sil 4.0mg	Change in LDL Cholesterol	-11.6 mg/dL	Standard Deviation 19.72

p-value: 0.6574ANCOVA

p-value: 0.8971ANCOVA

p-value: 0.6317ANCOVA

p-value: 0.0341ANCOVA

Secondary

Change in Percentage of Patients With ≥5% Body Weight Loss

The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168.

Time frame: Baseline to Day 168

Population: Analysis for Secondary Endpoint - Percentage of Subjects with ≥5% Relative Percentage Reduction from Baseline to day 168 in Body Weight by Treatment (Per-Protocol Population).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Change in Percentage of Patients With ≥5% Body Weight Loss	2 Participants
Leu Sil 1.0mg	Change in Percentage of Patients With ≥5% Body Weight Loss	1 Participants
Leu Sil 4.0mg	Change in Percentage of Patients With ≥5% Body Weight Loss	6 Participants
Leu Met Sil 1.0mg	Change in Percentage of Patients With ≥5% Body Weight Loss	7 Participants
Leu Met Sil 4.0mg	Change in Percentage of Patients With ≥5% Body Weight Loss	3 Participants

p-value: 1Chi-squared

p-value: 0.2646Chi-squared

p-value: 0.0749Chi-squared

p-value: 0.6758Chi-squared

Secondary

Change in Plasma Glucose

Change in plasma glucose was examined through standard fasting blood chemistry.

Time frame: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in Plasma Glucose	0.4 mg/dL	Standard Deviation 7.98
Leu Sil 1.0mg	Change in Plasma Glucose	-1.6 mg/dL	Standard Deviation 9.35
Leu Sil 4.0mg	Change in Plasma Glucose	0.3 mg/dL	Standard Deviation 9.59
Leu Met Sil 1.0mg	Change in Plasma Glucose	1.1 mg/dL	Standard Deviation 12.43
Leu Met Sil 4.0mg	Change in Plasma Glucose	-1.7 mg/dL	Standard Deviation 10.87

p-value: 0.6726ANCOVA

p-value: 0.7934ANCOVA

p-value: 0.5485ANCOVA

p-value: 0.3676ANCOVA

Secondary

Change in Systolic Blood Pressure

Change in Systolic blood pressure was assessed in patients from baseline to Day 168

Time frame: Baseline, Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in Systolic Blood Pressure	-2.0 mmHg	Standard Deviation 9.97
Leu Sil 1.0mg	Change in Systolic Blood Pressure	0.5 mmHg	Standard Deviation 12.21
Leu Sil 4.0mg	Change in Systolic Blood Pressure	-2.7 mmHg	Standard Deviation 9.12
Leu Met Sil 1.0mg	Change in Systolic Blood Pressure	0.6 mmHg	Standard Deviation 9.31
Leu Met Sil 4.0mg	Change in Systolic Blood Pressure	-3.5 mmHg	Standard Deviation 9.29

p-value: 0.1843ANCOVA

p-value: 0.4411ANCOVA

p-value: 0.6991ANCOVA

p-value: 0.3721ANCOVA

Secondary

Change in Total Cholesterol

Changes in total cholesterol was examined by standard blood chemistry.

Time frame: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in Total Cholesterol	1.0 mg/dL	Standard Deviation 20.33
Leu Sil 1.0mg	Change in Total Cholesterol	0.2 mg/dL	Standard Deviation 20.96
Leu Sil 4.0mg	Change in Total Cholesterol	1.9 mg/dL	Standard Deviation 20.01
Leu Met Sil 1.0mg	Change in Total Cholesterol	-0.7 mg/dL	Standard Deviation 16.74
Leu Met Sil 4.0mg	Change in Total Cholesterol	-6.6 mg/dL	Standard Deviation 23.48

p-value: 0.601ANCOVA

p-value: 0.6513ANCOVA

p-value: 0.4354ANCOVA

p-value: 0.031ANCOVA

Secondary

Change in Triglycerides

The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.

Time frame: Baseline, Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in Triglycerides	13.4 mg/dL	Standard Deviation 45.43
Leu Sil 1.0mg	Change in Triglycerides	9.7 mg/dL	Standard Deviation 56.42
Leu Sil 4.0mg	Change in Triglycerides	1.9 mg/dL	Standard Deviation 51.93
Leu Met Sil 1.0mg	Change in Triglycerides	-4.4 mg/dL	Standard Deviation 47.02
Leu Met Sil 4.0mg	Change in Triglycerides	3.5 mg/dL	Standard Deviation 52.03

p-value: 0.372ANCOVA

p-value: 0.2302ANCOVA

p-value: 0.1377ANCOVA

p-value: 0.4295ANCOVA

Secondary

Change in Waist Circumference

The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168.

Time frame: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Waist Circumference from Baseline (Per-Protocol Population).

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change in Waist Circumference	0.043 cm	Standard Deviation 5.5591
Leu Sil 1.0mg	Change in Waist Circumference	0.028 cm	Standard Deviation 5.5152
Leu Sil 4.0mg	Change in Waist Circumference	-1.060 cm	Standard Deviation 5.5564
Leu Met Sil 1.0mg	Change in Waist Circumference	-1.841 cm	Standard Deviation 4.7654
Leu Met Sil 4.0mg	Change in Waist Circumference	0.637 cm	Standard Deviation 5.7908

p-value: 0.9656ANCOVA

p-value: 0.4254ANCOVA

p-value: 0.1276ANCOVA

p-value: 0.5937ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage Body Weight Change

Change in Absolute Body Weight

Change in Diastolic Blood Pressure

Change in HDL Cholesterol

Change in Hemoglobin A1c (HbA1c)

Change in Inflammatory Markers

Change in LDL Cholesterol

Change in Percentage of Patients With ≥5% Body Weight Loss

Change in Plasma Glucose

Change in Systolic Blood Pressure

Change in Total Cholesterol

Change in Triglycerides

Change in Waist Circumference