Clinical Trial

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

Study acronym: NS-HTN-01
Not Yet Recruiting Phase 2
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Summary
This 12-week, randomized, double-blind, placebo-controlled Phase 2 study will evaluate two fixed-dose oral combinations of L-leucine, sildenafil, and metformin (NS-0200) versus matching placebo in adults 18-75 years with hypertension. Approximately 150 subjects will be screened to randomize \~150 (≈50 per arm) with an expected completer population of \~120. The primary objective is to compare change in mean seated systolic blood pressure from baseline (Day 1) to Week 12 (Day 84) for each NS-0200 dose versus placebo. Secondary outcomes include change in seated diastolic blood pressure and change in body weight. Safety will be monitored through adverse events, labs, vital signs, ECGs, and pregnancy testing.
Trial Details
NCT Number NCT07647003
Lead Sponsor NuSirt Biopharma
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Hypertension
Enrollment 150 participants
Start Date 2026-10-15
Primary Completion 2027-05-02 (estimated)
Study Completion 2027-07-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-15