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

NCT07647003 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-06-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

DRUG

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

OTHER

Placebo

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • NuSirt Biopharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-15
Primary Completion
2027-05-02
Completion
2027-07-07
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647003 on ClinicalTrials.gov