A Study to Evaluate the Effect of Two Fixed-Dose Leucine, Sildenafil and Metformin Combinations on Blood Pressure in Individuals With Hypertension

This is a 12-week, randomized, placebo-controlled, double-blind Phase 2 trial of two fixed-dose combinations (FDC) of L-leucine, sildenafil and metformin (NS-0200) versus placebo in adults 18-75 years with seated systolic blood pressure \>130 mmHg who meet inclusion/exclusion criteria. Screening (Visit 1, Day -7) precedes Baseline/Randomization and first dose on Day 1 (Visit 2). Visits occur at Day 28 (Week 4) and Day 56 (Week 8); telephone contacts occur at Days 14, 42, and 70; Study Termination is Day 84 (Week 12). Study medication is self-administered orally BID (30 minutes before meals) as three tablets per dose. Subjects randomized 1:1:1 to placebo or one of two NS-0200 dose levels; stratified by baseline SBP (\<145 vs ≥145 mmHg). Primary analysis compares change in mean seated SBP from Baseline (Day 1) to Day 84 for each active arm versus placebo using mixed-model ANCOVA; missing data handled with multiple imputation. Safety assessments include TEAEs/SAEs, clinical labs, ECGs, vitals, pregnancy testing, and monitoring for lactic acidosis, hypotension and vision changes