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

Sponsor
NuSirt Biopharma (Industry)
Overall Status
Completed
CT.gov ID
NCT03364335
Collaborator
(none)
267
Enrollment
15
Locations
5
Arms
7.3
Actual Duration (Months)
17.8
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Leu Sil 1.0mg
  • Drug: Leu Sil 4.0mg
  • Drug: Leu Met Sil 1.0mg
  • Drug: Leu Met Sil 4.0mg
  • Drug: Placebo
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
267 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
This is a double blind, placebo controlled trial
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 8, 2018
Actual Primary Completion Date :
Aug 6, 2018
Actual Study Completion Date :
Aug 17, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Each dose of placebo will consist of three tablets, identical in appearance to those used in the two active treatment arms, containing 93.5% Microcrystalline cellulose PH 102, 5.0% Crospovidone XL 10, 1.0% Silica gel (Syloid 244), 0.5% Magnesium stearate I MF3V for the leucine matched placebo and 99.5% Avicel PH200 , 0.5% magnesium stearate (w/w) and Opadry II White coating 3% weight gain for the sildenafil matched placebo.

Drug: Placebo
Placebo
Experimental: 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

Drug: Leu Sil 1.0mg
Leu 1100 mg + 1mg Sil BID
Other Names:
  • NS-0300-1.0

    • Drug: Leu Sil 4.0mg
    Leu 1100 mg + 4mg Sil BID
    Other Names:
  • NS-0300-4.0

    		•
    Experimental: 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

    Drug: Leu Sil 1.0mg
    Leu 1100 mg + 1mg Sil BID
    Other Names:
  • NS-0300-1.0

    • Drug: Leu Met Sil 1.0mg
    Leu 1100 mg + Met 500mg + 1mg Sil BID
    Other Names:
  • NS-0200-1.0

    		•
    Experimental: 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

    Drug: Leu Sil 1.0mg
    Leu 1100 mg + 1mg Sil BID
    Other Names:
  • NS-0300-1.0

    • Drug: Leu Sil 4.0mg
    Leu 1100 mg + 4mg Sil BID
    Other Names:
  • NS-0300-4.0

    • Drug: Leu Met Sil 4.0mg
    Leu 1100 mg + Met 500mg + 4mg Sil BID
    Other Names:
  • NS-0200-4.0

    		•
    Experimental: 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

    Drug: Leu Sil 1.0mg
    Leu 1100 mg + 1mg Sil BID
    Other Names:
  • NS-0300-1.0

    • Drug: Leu Met Sil 1.0mg
    Leu 1100 mg + Met 500mg + 1mg Sil BID
    Other Names:
  • NS-0200-1.0

    • Drug: Leu Met Sil 4.0mg
    Leu 1100 mg + Met 500mg + 4mg Sil BID
    Other Names:
  • NS-0200-4.0

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage Body Weight Change [Baseline to Day 168]

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

    Secondary Outcome Measures

    1. Change in Absolute Body Weight [Baseline to Day 168]

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

    2. 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.

    3. 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.

    4. Change in Total Cholesterol [Baseline to Day 168]

      Changes in total cholesterol was examined by standard blood chemistry.

    5. Change in HDL Cholesterol [Baseline, Day 168]

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

    6. Change in LDL Cholesterol [Baseline, 168 days]

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

    7. Change in Triglycerides [Baseline, Day 168]

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

    8. Change in Plasma Glucose [Baseline to Day 168]

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

    9. Change in Hemoglobin A1c (HbA1c) [Baseline, Day 168]

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

    10. Change in Diastolic Blood Pressure [Baseline to Day 168]

      Diastolic blood pressure was measured by standard blood pressure monitor.

    11. Change in Systolic Blood Pressure [Baseline, Day 168]

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

    12. Change in Inflammatory Markers [Baseline to Day 168]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age ≥18 and ≤65 at study entry.

    2. Is male, or female and, if female, meets all of the following criteria:

    3. Not breastfeeding

    4. 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)

    5. 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

    6. Stable body weight (±5%) and health over the last 3 months.

    7. Has a BMI between 30 kg/m2 and 45 kg/m2

    8. Stable diet within the last three months

    9. 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

    10. Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) either normal, not clinically significant or with abnormalities consistent with obesity

    11. 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.

    Exclusion Criteria:

    1. Diagnosis of diabetes or on a diabetes medication

    2. HbA1c ≥6.5% at Screening/Visit 1 (Day-7/Week-1)

    3. Severe renal impairment (eGFR < 45 mg/mL/1.73 m2) and/or patients with acute or chronic metabolic acidosis. Acidosis is defined as >25mmol/L computed without K.

    Normal is 8- 16, but acidosis is >25

    1. Use of any of the following medications in the eight weeks prior to entering screening for study participation and during the study:

    2. Use of any anti-diabetes medication including metformin and any combination drug that contains metformin

    3. Sildenafil

    4. Tadalafil

    5. Vardenafil

    6. OCT2/MATE inhibitors (e.g. cimetidine, quinidine, and pyrimethamine)

    7. Riociguat (guanylate cyclase stimulant)

    8. Alpha blockers

    9. Nitrates (e.g. oral nitrates, sublingual nitroglycerine and nitroglycerine patches)

    10. Potent CYP3A4 inhibitors (e.g. clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir)

    11. All antihypertensive medications

    12. Medications associated with weight changes

    • Drugs approved for the treatment of obesity

    • Cypropheptadine or medroxyprogesterone

    • Atypical anti-psychotic drugs

    • Tricyclic antidepressants

    • Lithium, MAO's, glucocorticoids

    • SSRI's or SNRI's

    • Antiepileptic drugs

    • Systemic corticosteroids

    • Stimulants e.g. amphetamines

    1. Any dietary supplement that is labeled for weight management or maintenance of healthy weight

    2. Diagnosis or evidence of eating disorders

    3. ≥ 5% weight change in the last 3 months

    4. Subjects who have had bariatric surgery

    5. An infection requiring antibiotic treatment within the last 30 days

    6. Any chronic inflammatory disease, e.g. inflammatory bowel disease rheumatoid arthritis, vasculitis, systemic lupus erythematosus

    7. Diseases interfering with metabolism (including metabolism of branched chain amino acids) and/or ingestive behavior (myxedema, Cushing's disease, diabetes, schizophrenia, major psychoses, maple syrup urine disease, unmanaged depression etc.)

    8. History of alcohol abuse (defined ≥ 21 drinks per week for males and > 14 drinks per week for females), within the past 3 months or failure on urinary drug screen

    9. History of substance abuse (including alcohol abuse as defined above) in the past 12 months or a positive screen for drugs (opioids without a prescription), including marijuana, of abuse or alcohol at screening.

    10. Has received any investigational drug within 3 months of Screening.

    11. Has donated blood within 3 months before Screening or is planning to donate blood during the study (due to HbA1c reading at screening)

    12. Other medical conditions that may diminish life expectancy to <2 years, including known cancers

    13. Have been diagnosed with metastatic carcinomas in the last 5 years

    14. Has known allergies or hypersensitivity to metformin, sildenafil or leucine

    15. Have suffered myocardial infarction, stroke, arrhythmia in the last 6 months

    16. Resting hypotension (BP <90/50 mmHg) or severe hypertension (BP >170/110 mmHg) If both or one of the parameters for diastolic or systolic BP is meet

    17. Cardiac failure or coronary artery disease causing unstable angina

    18. History or evidence at screening of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure

    19. At risk for priapism due to anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease) or other conditions that predispose to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia)

    20. Clinical evidence of hepatic impairment and/or ALT/AST >5X ULN

    21. Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the clinical study site, or NuSirt Biopharma.

    22. Is employed by NuSirt Biopharma (defined as an employee, temporary contract worker, or designee responsible for the conduct of the study).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AMR Mobile Alabama United States 36608
    2 Catalina Research Institute Montclair California United States 91763
    3 Northern California Research Sacramento California United States 95821
    4 ACR Meridian Idaho United States 83642
    5 Synexus Chicago Illinois United States 60602
    6 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808
    7 Clinical Trials Management Metairie Louisiana United States 70006
    8 Synexus Saint Louis Missouri United States 63141
    9 AMR Las Vegas Nevada United States 89119
    10 Rapid Medical Research Cleveland Ohio United States 44122
    11 Medical Research South Charleston South Carolina United States 29407
    12 Premier Clarksville Tennessee United States 37040
    13 Synexus Dallas Texas United States 75234
    14 Synexus San Antonio Texas United States 78229
    15 ACR Jordan Utah United States 84088

    Sponsors and Collaborators

    • NuSirt Biopharma

    Investigators

    • Study Chair: Michael B Zemel, PhD, NuSirt Biopharma

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    NuSirt Biopharma
    ClinicalTrials.gov Identifier:
    NCT03364335
    Other Study ID Numbers:
    • NS-WM-01
    First Posted:
    Dec 6, 2017
    Last Update Posted:
    Aug 21, 2019
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Obesity

    Study Results

    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 Detail 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.
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Period Title: Overall Study
    STARTED 52 51 53 50 52
    COMPLETED 42 40 42 37 41
    NOT COMPLETED 10 11 11 13 11

    Baseline Characteristics

    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg Total
    Arm/Group Description Placebo: Placebo 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 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 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 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 Total of all reporting groups
    Overall Participants 52 51 53 50 52 258
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    52
    100%
    51
    100%
    53
    100%
    50
    100%
    52
    100%
    258
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    41.29
    (11.30)
    40.94
    (11.14)
    39.55
    (11.14)
    41.36
    (12.66)
    42.89
    (10.70)
    41.20
    (11.36)
    Sex: Female, Male (Count of Participants)
    Female
    38
    73.1%
    29
    56.9%
    32
    60.4%
    39
    78%
    35
    67.3%
    173
    67.1%
    Male
    14
    26.9%
    22
    43.1%
    21
    39.6%
    11
    22%
    17
    32.7%
    85
    32.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    8
    15.4%
    12
    23.5%
    13
    24.5%
    12
    24%
    15
    28.8%
    60
    23.3%
    Not Hispanic or Latino
    44
    84.6%
    39
    76.5%
    40
    75.5%
    38
    76%
    37
    71.2%
    198
    76.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    1.9%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.4%
    Asian
    0
    0%
    0
    0%
    1
    1.9%
    2
    4%
    1
    1.9%
    4
    1.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    9
    17.3%
    9
    17.6%
    13
    24.5%
    11
    22%
    11
    21.2%
    53
    20.5%
    White
    40
    76.9%
    42
    82.4%
    39
    73.6%
    37
    74%
    40
    76.9%
    198
    76.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    2
    3.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    0.8%
    Weight (kg) (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    101.67
    (13.856)
    105.05
    (15.568)
    107.16
    (17.962)
    100.18
    (16.991)
    104.50
    (17.405)
    103.74
    (16.49)
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    35.773
    (3.31)
    37.179
    (4.28)
    37.9
    (4.20)
    36.425
    (4.13)
    37.152
    (4.23)
    36.89
    (4.08)
    Waist Circumference (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    110.40
    (10.998)
    112.91
    (11.466)
    116.02
    (12.411)
    111.17
    (13.291)
    112.93
    (13.311)
    112.71
    (12.39)

    Outcome Measures

    1. Primary Outcome
    Title Percentage Body Weight Change
    Description The percentage body weight change from baseline to Day 168 was evaluated.
    Time Frame Baseline to Day 168

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Primary Endpoint - Percent Change in Body Weight from Baseline to Day 168 in per protocol population.
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [percentage]
    1.121
    (3.6241)
    0.674
    (3.2286)
    -0.489
    (3.9041)
    -0.929
    (4.5533)
    -0.552
    (2.5924)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.5461
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0364
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0156
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0349
    Comments
    Method ANCOVA
    Comments
    2. Secondary Outcome
    Title Change in Absolute Body Weight
    Description The change in absolute body weight from baseline to day 168 was evaluated.
    Time Frame Baseline to Day 168

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in Absolute Body Weight from Baseline to day 168 (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [kg]
    1.126
    (3.5903)
    0.678
    (3.2502)
    -0.460
    (4.0352)
    -0.870
    (4.5445)
    -0.461
    (2.7583)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.5348
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0379
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0215
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0464
    Comments
    Method ANCOVA
    Comments
    3. Secondary Outcome
    Title Change in Percentage of Patients With ≥5% Body Weight Loss
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Count of Participants [Participants]
    2
    3.8%
    1
    2%
    6
    11.3%
    7
    14%
    3
    5.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.2646
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0749
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.6758
    Comments
    Method Chi-squared
    Comments
    4. Secondary Outcome
    Title Change in Waist Circumference
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in Waist Circumference from Baseline (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [cm]
    0.043
    (5.5591)
    0.028
    (5.5152)
    -1.060
    (5.5564)
    -1.841
    (4.7654)
    0.637
    (5.7908)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.9656
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.4254
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.1276
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.5937
    Comments
    Method ANCOVA
    Comments
    5. Secondary Outcome
    Title Change in Total Cholesterol
    Description Changes in total cholesterol was examined by standard blood chemistry.
    Time Frame Baseline to Day 168

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [mg/dL]
    1.0
    (20.33)
    0.2
    (20.96)
    1.9
    (20.01)
    -0.7
    (16.74)
    -6.6
    (23.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.6010
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.6513
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.4354
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0310
    Comments
    Method ANCOVA
    Comments
    6. Secondary Outcome
    Title Change in HDL Cholesterol
    Description Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.
    Time Frame Baseline, Day 168

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [mg/dL]
    1.1
    (7.43)
    0.6
    (7.59)
    2.4
    (6.40)
    1.8
    (8.21)
    1.6
    (7.72)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.4644
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.8573
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.8167
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.9223
    Comments
    Method ANCOVA
    Comments
    7. Secondary Outcome
    Title Change in LDL Cholesterol
    Description Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.
    Time Frame Baseline, 168 days

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [mg/dL]
    -5.5
    (15.40)
    -6.6
    (16.86)
    -4.2
    (15.81)
    -5.5
    (11.77)
    -11.6
    (19.72)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.6574
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.8971
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.6317
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0341
    Comments
    Method ANCOVA
    Comments
    8. Secondary Outcome
    Title Change in Triglycerides
    Description The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.
    Time Frame Baseline, Day 168

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [mg/dL]
    13.4
    (45.43)
    9.7
    (56.42)
    1.9
    (51.93)
    -4.4
    (47.02)
    3.5
    (52.03)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.3720
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.2302
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.1377
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.4295
    Comments
    Method ANCOVA
    Comments
    9. Secondary Outcome
    Title Change in Plasma Glucose
    Description Change in plasma glucose was examined through standard fasting blood chemistry.
    Time Frame Baseline to Day 168

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [mg/dL]
    0.4
    (7.98)
    -1.6
    (9.35)
    0.3
    (9.59)
    1.1
    (12.43)
    -1.7
    (10.87)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.6726
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.7934
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.5485
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.3676
    Comments
    Method ANCOVA
    Comments
    10. Secondary Outcome
    Title Change in Hemoglobin A1c (HbA1c)
    Description Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.
    Time Frame Baseline, Day 168

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in HbA1c from Baseline to day 168 (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [percentage of glycosylated hemoglobin]
    0.16
    (0.164)
    0.09
    (0.167)
    0.11
    (0.165)
    0.07
    (0.198)
    0.09
    (0.177)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.1653
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.1970
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0608
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.1583
    Comments
    Method ANCOVA
    Comments
    11. Secondary Outcome
    Title Change in Diastolic Blood Pressure
    Description Diastolic blood pressure was measured by standard blood pressure monitor.
    Time Frame Baseline to Day 168

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population)
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [mmHg]
    -1.7
    (7.13)
    1.8
    (9.57)
    -2.6
    (8.10)
    1.1
    (9.16)
    -3.3
    (7.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0524
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.5221
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.3702
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.5426
    Comments
    Method ANCOVA
    Comments
    12. Secondary Outcome
    Title Change in Systolic Blood Pressure
    Description Change in Systolic blood pressure was assessed in patients from baseline to Day 168
    Time Frame Baseline, Day 168

    Outcome Measure Data

    Analysis Population Description
    ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [mmHg]
    -2.0
    (9.97)
    0.5
    (12.21)
    -2.7
    (9.12)
    0.6
    (9.31)
    -3.5
    (9.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.1843
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.4411
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.6991
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.3721
    Comments
    Method ANCOVA
    Comments
    13. Secondary Outcome
    Title Change in Inflammatory Markers
    Description hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry.
    Time Frame Baseline to Day 168

    Outcome Measure Data

    Analysis Population Description
    Descriptive Statistics for Secondary Endpoint - hs-C-Reactive Protein Change from Baseline to day 168 (Per-Protocol Population).
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    Measure Participants 42 40 42 37 41
    Mean (Standard Deviation) [mg/L]
    0.90
    (2.401)
    0.12
    (3.633)
    0.35
    (3.385)
    0.56
    (6.624)
    0.12
    (3.551)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0318
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.3827
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 1.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.0050
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Leu Met Sil 4.0mg
    Comments
    Type of Statistical Test Other
    Comments Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.
    Statistical Test of Hypothesis p-Value 0.1045
    Comments
    Method ANCOVA
    Comments

    Adverse Events

    Time Frame 6 months
    Adverse Event Reporting Description Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
    Arm/Group Title Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Arm/Group Description Placebo: Placebo 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 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 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 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
    All Cause Mortality
    Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/52 (0%) 0/51 (0%) 0/53 (0%) 0/50 (0%) 0/52 (0%)
    Serious Adverse Events
    Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/52 (0%) 2/51 (3.9%) 0/53 (0%) 1/50 (2%) 0/52 (0%)
    Infections and infestations
    Tooth abscess 0/52 (0%) 0 1/51 (2%) 1 0/53 (0%) 0 0/50 (0%) 0 0/52 (0%) 0
    Metabolism and nutrition disorders
    Hypokalaemia 0/52 (0%) 0 1/51 (2%) 1 0/53 (0%) 0 0/50 (0%) 0 0/52 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anal Cancer 0/52 (0%) 0 1/51 (2%) 1 0/53 (0%) 0 0/50 (0%) 0 0/52 (0%) 0
    Metastatic malignant melanoma 0/52 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 1/50 (2%) 1 0/52 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo Leu Sil 1.0mg Leu Sil 4.0mg Leu Met Sil 1.0mg Leu Met Sil 4.0mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/52 (26.9%) 19/51 (37.3%) 12/53 (22.6%) 21/50 (42%) 19/52 (36.5%)
    Blood and lymphatic system disorders
    C-reactive protein increased 1/52 (1.9%) 1 0/51 (0%) 0 0/53 (0%) 0 0/50 (0%) 0 3/52 (5.8%) 3
    Hypertension 3/52 (5.8%) 3 0/51 (0%) 0 0/53 (0%) 0 0/50 (0%) 0 0/52 (0%) 0
    Gastrointestinal disorders
    Abdominal Pain 1/52 (1.9%) 1 0/51 (0%) 0 1/53 (1.9%) 1 3/50 (6%) 3 1/52 (1.9%) 1
    General disorders
    Headache 4/52 (7.7%) 4 6/51 (11.8%) 6 0/53 (0%) 0 4/50 (8%) 4 5/52 (9.6%) 5
    Increased Appetite 2/52 (3.8%) 2 4/51 (7.8%) 4 2/53 (3.8%) 2 2/50 (4%) 2 3/52 (5.8%) 3
    Influenza 0/52 (0%) 0 1/51 (2%) 1 2/53 (3.8%) 2 3/50 (6%) 3 0/52 (0%) 0
    Nausea 1/52 (1.9%) 1 4/51 (7.8%) 4 1/53 (1.9%) 1 4/50 (8%) 4 6/52 (11.5%) 6
    Nasopharyngitis 1/52 (1.9%) 1 5/51 (9.8%) 5 0/53 (0%) 0 1/50 (2%) 1 2/52 (3.8%) 2
    Pharyngitis 0/52 (0%) 0 3/51 (5.9%) 3 0/53 (0%) 0 0/50 (0%) 0 0/52 (0%) 0
    Sinusitis 1/52 (1.9%) 1 0/51 (0%) 0 0/53 (0%) 0 0/50 (0%) 0 4/52 (7.7%) 4
    Viral infection 2/52 (3.8%) 2 3/51 (5.9%) 3 3/53 (5.7%) 3 2/50 (4%) 2 1/52 (1.9%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/52 (0%) 0 4/51 (7.8%) 4 0/53 (0%) 0 0/50 (0%) 0 0/52 (0%) 0
    Back Pain 0/52 (0%) 0 0/51 (0%) 0 1/53 (1.9%) 1 3/50 (6%) 3 1/52 (1.9%) 1
    Renal and urinary disorders
    Constipation 3/52 (5.8%) 3 2/51 (3.9%) 2 1/53 (1.9%) 1 1/50 (2%) 1 1/52 (1.9%) 1
    Diarrhoea 1/52 (1.9%) 1 2/51 (3.9%) 2 4/53 (7.5%) 4 21/50 (42%) 21 12/52 (23.1%) 12
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection 5/52 (9.6%) 5 6/51 (11.8%) 6 2/53 (3.8%) 2 4/50 (8%) 4 4/52 (7.7%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Barbara Cannon
    Organization NuSirt Biopharma
    Phone 6156567898
    Email BCannon@nusirt.com
    Responsible Party:
    NuSirt Biopharma
    ClinicalTrials.gov Identifier:
    NCT03364335
    Other Study ID Numbers:
    • NS-WM-01
    First Posted:
    Dec 6, 2017
    Last Update Posted:
    Aug 21, 2019
    Last Verified:
    Nov 1, 2018