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

Sponsor
NuSirt Biopharma
Study ID
NCT07647003
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NS-0200 (low sildenafil) — DRUG
    Two tablets 550 mg L-leucine + 250 mg metformin and one tablet 1.0 mg sildenafil per dose; 3 tablets/dose orally BID
  • NS-0200 (higher sildenafil) — DRUG
    Two tablets 550 mg L-leucine + 250 mg metformin and one tablet 4.0 mg sildenafil per dose; 3 tablets/dose orally BID
  • Placebo — OTHER
    9.5% 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; 99.5% Avicel PH200, 0.5% magnesium stearate (w/w) and Opadry II White coating 3% weight gain for the sildenafil matched placebo, self-administered by the patient as 3 tablets taken orally bid within 30 minutes prior to the morning and evening meal

Study Details

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.

Key Dates

First listed
Jun 15, 2026
Start date
Oct 15, 2026
Status verified
Jun 2026
Primary completion
May 2, 2027
Completion
Jul 7, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    3 tablets/dose orally BID (30 min before meals)
  • Experimental: NS-0200 (low sildenafil)
    two tablets 550 mg L-leucine + 250 mg metformin and one tablet 1.0 mg sildenafil per dose; 3 tablets/dose orally BID
  • Experimental: NS-0200 (higher sildenafil)
    two tablets 550 mg L-leucine + 250 mg metformin and one tablet 4.0 mg sildenafil per dose; 3 tablets/dose orally BID

Primary Outcome Measure

Change in systolic blood pressure compared to placebo from baseline to study termination [ Time Frame: From baseline to study completion, approximately 12 weeks ]

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