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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| Leu Sil 1.0mg | Experimental | 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil |
|
| Leu Sil 4.0mg | Experimental | 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil |
|
| Leu Met Sil 1.0mg | Experimental | 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 |
|
| Leu Met Sil 4.0mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leu Sil 1.0mg | Drug | Leu 1100 mg + 1mg Sil BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Body Weight Change | The percentage body weight change from baseline to Day 168 was evaluated. | Baseline to Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Absolute Body Weight | The change in absolute body weight from baseline to day 168 was evaluated. | Baseline to Day 168 |
| 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. |
Not provided
Inclusion Criteria:
Age ≥18 and ≤65 at study entry.
Is male, or female and, if female, meets all of the following criteria:
Stable body weight (±5%) and health over the last 3 months.
Has a BMI between 30 kg/m2 and 45 kg/m2
Stable diet within the last three months
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
Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) either normal, not clinically significant or with abnormalities consistent with obesity
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:
Diagnosis of diabetes or on a diabetes medication
HbA1c ≥6.5% at Screening/Visit 1 (Day-7/Week-1)
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
Use of any of the following medications in the eight weeks prior to entering screening for study participation and during the study:
Use of any anti-diabetes medication including metformin and any combination drug that contains metformin
Sildenafil
Tadalafil
Vardenafil
OCT2/MATE inhibitors (e.g. cimetidine, quinidine, and pyrimethamine)
Riociguat (guanylate cyclase stimulant)
Alpha blockers
Nitrates (e.g. oral nitrates, sublingual nitroglycerine and nitroglycerine patches)
Potent CYP3A4 inhibitors (e.g. clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir)
All antihypertensive medications
Medications associated with weight changes
Any dietary supplement that is labeled for weight management or maintenance of healthy weight
Diagnosis or evidence of eating disorders
≥ 5% weight change in the last 3 months
Subjects who have had bariatric surgery
An infection requiring antibiotic treatment within the last 30 days
Any chronic inflammatory disease, e.g. inflammatory bowel disease rheumatoid arthritis, vasculitis, systemic lupus erythematosus
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.)
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
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.
Has received any investigational drug within 3 months of Screening.
Has donated blood within 3 months before Screening or is planning to donate blood during the study (due to HbA1c reading at screening)
Other medical conditions that may diminish life expectancy to <2 years, including known cancers
Have been diagnosed with metastatic carcinomas in the last 5 years
Has known allergies or hypersensitivity to metformin, sildenafil or leucine
Have suffered myocardial infarction, stroke, arrhythmia in the last 6 months
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
Cardiac failure or coronary artery disease causing unstable angina
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
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)
Clinical evidence of hepatic impairment and/or ALT/AST >5X ULN
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.
Is employed by NuSirt Biopharma (defined as an employee, temporary contract worker, or designee responsible for the conduct of the study).
Maximum of 70% female
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| Name | Affiliation | Role |
|---|---|---|
| Michael B Zemel, PhD | NuSirt Biopharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMR | Mobile | Alabama | 36608 | United States | ||
| Catalina Research Institute |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 4, 2017 | Oct 23, 2018 |
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This is a double blind, placebo controlled trial
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 |
|
| Leu Sil 4.0mg | Drug | Leu 1100 mg + 4mg Sil BID |
|
|
| Leu Met Sil 1.0mg | Drug | Leu 1100 mg + Met 500mg + 1mg Sil BID |
|
|
| Leu Met Sil 4.0mg | Drug | Leu 1100 mg + Met 500mg + 4mg Sil BID |
|
|
| Placebo | Drug | Placebo |
|
| Baseline to Day 168 |
| 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. | Baseline to Day 168 |
| Change in Total Cholesterol | Changes in total cholesterol was examined by standard blood chemistry. | Baseline to Day 168 |
| Change in HDL Cholesterol | Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry. | Baseline, Day 168 |
| Change in LDL Cholesterol | Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168. | Baseline, 168 days |
| Change in Triglycerides | The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168. | Baseline, Day 168 |
| Change in Plasma Glucose | Change in plasma glucose was examined through standard fasting blood chemistry. | Baseline to Day 168 |
| Change in Hemoglobin A1c (HbA1c) | Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168. | Baseline, Day 168 |
| Change in Diastolic Blood Pressure | Diastolic blood pressure was measured by standard blood pressure monitor. | Baseline to Day 168 |
| Change in Systolic Blood Pressure | Change in Systolic blood pressure was assessed in patients from baseline to Day 168 | Baseline, Day 168 |
| Change in Inflammatory Markers | hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry. | Baseline to Day 168 |
| Montclair |
| California |
| 91763 |
| United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| ACR | Meridian | Idaho | 83642 | United States |
| Synexus | Chicago | Illinois | 60602 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| Clinical Trials Management | Metairie | Louisiana | 70006 | United States |
| Synexus | St Louis | Missouri | 63141 | United States |
| AMR | Las Vegas | Nevada | 89119 | United States |
| Rapid Medical Research | Cleveland | Ohio | 44122 | United States |
| Medical Research South | Charleston | South Carolina | 29407 | United States |
| Premier | Clarksville | Tennessee | 37040 | United States |
| Synexus | Dallas | Texas | 75234 | United States |
| Synexus | San Antonio | Texas | 78229 | United States |
| ACR | Jordan | Utah | 84088 | United States |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects who met the inclusion criteria, with BMI between 30kg/m2 and 45kg/m2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Body Weight Change | The percentage body weight change from baseline to Day 168 was evaluated. | ANCOVA Analysis for Primary Endpoint - Percent Change in Body Weight from Baseline to Day 168 in per protocol population. | Posted | Mean | Standard Deviation | percentage | Baseline to Day 168 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Absolute Body Weight | The change in absolute body weight from baseline to day 168 was evaluated. | ANCOVA Analysis for Secondary Endpoint - Change in Absolute Body Weight from Baseline to day 168 (Per-Protocol Population). | Posted | Mean | Standard Deviation | kg | Baseline to Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Count of Participants | Participants | Baseline to Day 168 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | ANCOVA Analysis for Secondary Endpoint - Change in Waist Circumference from Baseline (Per-Protocol Population). | Posted | Mean | Standard Deviation | cm | Baseline to Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Total Cholesterol | Changes in total cholesterol was examined by standard blood chemistry. | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | Posted | Mean | Standard Deviation | mg/dL | Baseline to Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in HDL Cholesterol | Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry. | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in LDL Cholesterol | Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168. | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | Posted | Mean | Standard Deviation | mg/dL | Baseline, 168 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Triglycerides | The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168. | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Plasma Glucose | Change in plasma glucose was examined through standard fasting blood chemistry. | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | Posted | Mean | Standard Deviation | mg/dL | Baseline to Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hemoglobin A1c (HbA1c) | Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168. | ANCOVA Analysis for Secondary Endpoint - Change in HbA1c from Baseline to day 168 (Per-Protocol Population). | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline, Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diastolic Blood Pressure | Diastolic blood pressure was measured by standard blood pressure monitor. | ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population) | Posted | Mean | Standard Deviation | mmHg | Baseline to Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Systolic Blood Pressure | Change in Systolic blood pressure was assessed in patients from baseline to Day 168 | ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population). | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Inflammatory Markers | hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry. | Descriptive Statistics for Secondary Endpoint - hs-C-Reactive Protein Change from Baseline to day 168 (Per-Protocol Population). | Posted | Mean | Standard Deviation | mg/L | Baseline to Day 168 |
|
6 months
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Placebo | 0 | 52 | 0 | 52 | 14 | 52 |
| EG001 | 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 | 0 | 51 | 2 | 51 | 19 | 51 |
| EG002 | 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 | 0 | 53 | 0 | 53 | 12 | 53 |
| EG003 | 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 | 0 | 50 | 1 | 50 | 21 | 50 |
| EG004 | 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 | 0 | 52 | 0 | 52 | 19 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth abscess | Infections and infestations | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| C-reactive protein increased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Constipation | Renal and urinary disorders | Systematic Assessment |
| ||
| Diarrhoea | Renal and urinary disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Increased Appetite | General disorders | Systematic Assessment |
| ||
| Influenza | General disorders | Systematic Assessment |
| ||
| Nausea | General disorders | Systematic Assessment |
| ||
| Nasopharyngitis | General disorders | Systematic Assessment |
| ||
| Pharyngitis | General disorders | Systematic Assessment |
| ||
| Sinusitis | General disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Viral infection | General disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Cannon | NuSirt Biopharma | 6156567898 | BCannon@nusirt.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2017 | Oct 23, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.0364 |
| Other |
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. |
| ANCOVA | 0.0156 | Other | 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. |
| ANCOVA | 0.0349 | Other | 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. |
| OG004 | 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 |
|
|
|
| OG004 | 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 |
|
|
|
| OG004 | 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 |
|
|
|
| OG004 | 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 |
|
|
|
| OG004 | 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 |
|
|
|
| OG004 | 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 |
|
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| OG004 | 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 |
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| OG004 | 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 |
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| OG004 | 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 |
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| OG004 | 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 |
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| OG004 | 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 |
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| OG004 | 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 |
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