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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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).

Key facts

Study ID

NCT03364335

Run by

NuSirt Biopharma

People needed

267

Starts

2018-01-08

Expected to finish

2018-08-17

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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.

You may not qualify if…

• 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
• 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

Where it is running

• AMR — Mobile, Alabama, United States
• Catalina Research Institute — Montclair, California, United States
• Northern California Research — Sacramento, California, United States
• ACR — Meridian, Idaho, United States
• Synexus — Chicago, Illinois, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Clinical Trials Management — Metairie, Louisiana, United States
• Synexus — St Louis, Missouri, United States
• AMR — Las Vegas, Nevada, United States
• Rapid Medical Research — Cleveland, Ohio, United States
• Medical Research South — Charleston, South Carolina, United States
• Premier — Clarksville, Tennessee, United States
• Synexus — Dallas, Texas, United States
• Synexus — San Antonio, Texas, United States
• ACR — Jordan, Utah, United States

Full record on ClinicalTrials.gov

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