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

NCT03364335 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NS-WM-01
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 15

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).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percentage Body Weight Change

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

  Baseline to Day 168

Secondary Outcomes (12)

• Change in Absolute Body Weight

  Baseline to Day 168

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

  Baseline to Day 168

• Change in Waist Circumference

  Baseline to Day 168

• Change in Total Cholesterol

  Baseline to Day 168

• Change in HDL Cholesterol

  Baseline, Day 168

Study Arms (5)

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.

Drug: 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

Drug: Leu Sil 1.0mg; Drug: Leu Sil 4.0mg

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

Drug: Leu Sil 1.0mg; Drug: Leu Met Sil 1.0mg

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

Drug: Leu Sil 1.0mg; Drug: Leu Sil 4.0mg; Drug: Leu Met Sil 4.0mg

Leu Met Sil 4.0mg

EXPERIMENTAL

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; Drug: Leu Met Sil 1.0mg; Drug: Leu Met Sil 4.0mg

Interventions

Leu Sil 1.0mg DRUG

Leu 1100 mg + 1mg Sil BID

Also known as: NS-0300-1.0

Leu Met Sil 1.0mg; Leu Met Sil 4.0mg; Leu Sil 1.0mg; Leu Sil 4.0mg

Leu Sil 4.0mg DRUG

Leu 1100 mg + 4mg Sil BID

Also known as: NS-0300-4.0

Leu Met Sil 1.0mg; Leu Sil 1.0mg

Leu Met Sil 1.0mg DRUG

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

Also known as: NS-0200-1.0

Leu Met Sil 4.0mg; Leu Sil 4.0mg

Leu Met Sil 4.0mg DRUG

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

Also known as: NS-0200-4.0

Leu Met Sil 1.0mg; Leu Met Sil 4.0mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Maximum of 70% female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤65 at study entry.
• Is male, or female and, if female, meets all of the following criteria:
• Not breastfeeding
• 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)
• 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
• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• NuSirt Biopharma: lead

Study Sites (15)

AMR

Mobile, Alabama, 36608, United States

Location

Catalina Research Institute

Montclair, California, 91763, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

ACR

Meridian, Idaho, 83642, United States

Location

Synexus

Chicago, Illinois, 60602, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Clinical Trials Management

Metairie, Louisiana, 70006, United States

Location

Synexus

St Louis, Missouri, 63141, United States

Location

AMR

Las Vegas, Nevada, 89119, United States

Location

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

Medical Research South

Charleston, South Carolina, 29407, United States

Location

Premier

Clarksville, Tennessee, 37040, United States

Location

Synexus

Dallas, Texas, 75234, United States

Location

Synexus

San Antonio, Texas, 78229, United States

Location

ACR

Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Barbara Cannon
• Organization: NuSirt Biopharma

BCannon@nusirt.com

6156567898

Study Officials

• Michael B Zemel, PhD

  NuSirt Biopharma

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double blind, placebo controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: January 8, 2018
• Primary Completion: August 6, 2018
• Study Completion: August 17, 2018
• Last Updated: August 21, 2019
• Results First Posted: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)