leucine/metformin/sildenafil (NS-0200) / NuSirt - LARVOL DELTA

NS-HTN-01: A Study to Evaluate the Effect of Two Fixed-Dose Leucine, Sildenafil and Metformin Combinations on Blood Pressure in Individuals With Hypertension (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: NuSirt Biopharma

New P2 trial • Cardiovascular • Hypertension

Leucine and Sildenafil Combination Therapy Reduces Body Weight and Metformin Enhances the Effect at Low Dose: A Randomized Controlled Trial. (PubMed, Am J Ther) - "Leu/Met/Sil 1.0 and 4.0 and Leu/Sil 4.0 reduced body weight, but Leu/Met/Sil 1.0 was associated with robust weight loss in African Americans, and individuals with BMI 30-39.9 kg/m2, especially participants with hyperinsulinemia."

Clinical • Combination therapy • Journal • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity

Randomized Controlled Trial of a Leucine-Metformin-Sildenafil Combination (NS-0200) on Weight and Metabolic Parameters. (PubMed, Obesity (Silver Spring)) - "These data support further study of NS-0200 as a therapy for obesity and associated comorbidities."

Clinical • Journal

Randomised clinical trial: a leucine-metformin-sildenafil combination (NS-0200) vs placebo in patients with non-alcoholic fatty liver disease. (PubMed, Aliment Pharmacol Ther) - "These data support further evaluation of high-dose NS-0200 for treating NASH, especially in those with elevated ALT (NCT 02546609)."

Clinical • Journal

Editorial: role of leucine-metformin-sildenafil combination in the treatment of nonalcoholic fatty liver disease (NAFLD). (PubMed, Aliment Pharmacol Ther) - No abstract available.

Journal

NS-0200 (Leucine-Metformin-Sildenafil) Reduces Weight in Obese Subjects: A 24-Week Randomized Trial (ADA 2019) - "Similarly, treated subjects with BMI 35-39.9 had ~two-fold elevations in insulin and HOMAIR vs. those with BMI8 mU/L and HOMAIR>2 (p=0.017); those with elevated insulin at baseline lost ~twice as much weight as those with lower insulin (-3.8 vs. -1.8%), and 30% of this subgroup achieved 5% weight loss vs. 6% of placebo. These data indicate NS-0200 results in significant 6-month weight loss, especially in insulin-resistant subjects, and suggest therapeutic utility for obese insulin-resistant individuals."

Clinical

NS-0200 (Leucine-Metformin-Sildenafil) Reduces Weight in Obese Subjects: A 24-Week Randomized Trial (ADA 2019) - "Similarly, treated subjects with BMI 35-39.9 had ~two-fold elevations in insulin and HOMAIR vs. those with BMI8 mU/L and HOMAIR>2 (p=0.017); those with elevated insulin at baseline lost ~twice as much weight as those with lower insulin (-3.8 vs. -1.8%), and 30% of this subgroup achieved 5% weight loss vs. 6% of placebo. These data indicate NS-0200 results in significant 6-month weight loss, especially in insulin-resistant subjects, and suggest therapeutic utility for obese insulin-resistant individuals."

Clinical