HypertensionPhase 2NS-HTN-01NCT07647003
A Study to Evaluate the Effect of Two Fixed-Dose Leucine, Sildenafil and Metformin Combinations on Blood Pressure in Individuals With Hypertension
A Phase 2 study testing NS-0200 (low sildenafil) and NS-0200 (higher sildenafil) in people with Hypertension, run by NuSirt Biopharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- NS-0200 (low sildenafil) and NS-0200 (higher sildenafil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 7 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤75 at study entry.
- Is male, or female and, if female, meets all of the following criteria: (1) Not breastfeeding; (2) Post-menopausal or negative serum pregnancy test result (human chorionic gonadotropin, beta subunit [β- hCG]) at screening (not required for hysterectomized females); (3) If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized or same sex partner) during the entire duration of the study Stable body weight (±5%) and health over the last 3 months.
- Systolic pressure > 130 mm Hg
- Not on antihypertensive therapy for the preceding 30 days or on a stable dose over the 30 days preceding study entry of 1 or 2 antihypertensive agents.
- HbA1c <9%.
- If on insulin, must be on a stable regimen for 3 months preceding study entry.
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- If on GLP-1 agonist, must be on a stable regimen for 9 months with a stable total body weight for the preceding 3 months.
- Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) either normal or not clinically significant.
- Is able to read, understand, and sign the informed consent forms (ICF) and, when applicable, an authorization to use and disclose protected health information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements.
Who cannot join
- <18 or >75 years of age
- On >2 antihypertensive agent drug products
- Systolic pressure >160 mm Hg
- Diastolic pressure >110 mm Hg
- HbA1c >9% at screening
- Severe renal impairment (eGFR < 45 mg/mL/1.73 m2) and/or patients with acute or chronic metabolic acidosis (acidosis defined as >25mmol/L computed without K).
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- Use of any of the following medications in the eight weeks prior to entering screening for study participation and during the study: (1) Use of any anti-diabetes medication including metformin and any combination drug that contains metformin; (2) Sildenafil; (3) Tadalafil; (4) Vardenafil; (5) OCT2/MATE inhibitors (e.g. cimetidine, quinidine, and pyrimethamine); (6) Riociguat (guanylate cyclase stimulant); (7) Alpha blockers; (8) Nitrates (e.g. oral nitrates, sublingual nitroglycerine and nitroglycerine patches); (9) Potent CYP3A4 inhibitors (e.g., clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir)
- ≥ 5% weight change in the last 3 months
- Diseases interfering with metabolism (including metabolism of branched chain amino acids) and/or ingestive behavior (myxedema, Cushings disease, diabetes, schizophrenia, major psychoses, maple syrup urine disease, unmanaged depression etc.)
- History of alcohol abuse (defined ≥ 21 drinks per week for males and > 14 drinks per week for females), within the past 3 months or failure on urinary drug screen
- History of substance abuse (including alcohol abuse as defined above) in the past 12 months or a positive screen for drugs (opioids without a prescription) of abuse or alcohol at screening
- Has received any investigational drug within 3 months of screening
- Has donated blood within 3 months before screening or is planning to donate blood during the study (due to HbA1c reading at screening)
- Other medical conditions that may diminish life expectancy to <2 years, including known cancers
- Have been diagnosed with metastatic carcinomas in the last 5 years
- Has known allergies or hypersensitivity to metformin, sildenafil or leucine
- Have suffered myocardial infarction, stroke, arrhythmia in the last 6 months
- Cardiac failure or coronary artery disease causing unstable angina
- History or evidence at screening of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure
- At risk for priapism due to anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronies disease) or other conditions that predispose to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia)
- Clinical evidence of hepatic impairment and/or alanine aminotransferase (ALT) aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN)
- Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the clinical study site, or NuSirt Sciences, Inc. (NuSirt)
- Is employed by NuSirt (defined as an employee, temporary contract worker, or designee responsible for the conduct of the study)
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Two Fixed-Dose Leucine, Sildenafil and Metformin Combinations (NS-0200) Versus Placebo on Blood Pressure in Individuals With Hypertension
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.
Read the detailed description
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
- Conditions
- Hypertension
- Being tested
- NS-0200 (low sildenafil), NS-0200 (higher sildenafil), Placebo
- Keywords
- Hypertension, High blood pressure, NS-0200, Leucine, Sildenafil, Metformin, Blood pressure, Randomized, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS-0200 (low sildenafil)Drug
Also called TRIPLN (low sildenafil), TRIPLN
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
Also called TRIPLN (higher sildenafil), TRIPLN
Two tablets 550 mg L-leucine + 250 mg metformin and one tablet 4.0 mg sildenafil per dose; 3 tablets/dose orally BID
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 3 tablets/dose orally BID (30 min before meals) Receives: Other: Placebo |
| NS-0200 (low sildenafil) | Experimental | two tablets 550 mg L-leucine + 250 mg metformin and one tablet 1.0 mg sildenafil per dose; 3 tablets/dose orally BID Receives: Drug: NS-0200 (low sildenafil) |
| NS-0200 (higher sildenafil) | Experimental | two tablets 550 mg L-leucine + 250 mg metformin and one tablet 4.0 mg sildenafil per dose; 3 tablets/dose orally BID Receives: Drug: NS-0200 (higher sildenafil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure compared to placebo from baseline to study termination
Systolic blood pressure will be measured in all subjects at visits 1 through 5 or at early termination. BP will be taken using a standardized automated cuff-based instrument (Omron HEM-907XL or equivalent). Qualified site personnel will program the machine to capture a series of 3 measurements of SBP starting with a 5-minute delay for the first reading followed by a delay of 2 minutes between the subsequent readings.
Measured: From baseline to study completion, approximately 12 weeks
Secondary outcomes (2)
Change in diastolic blood pressure compared to placebo from baseline to study termination
Diastolic blood pressure will be measured in all subjects at visits 1 through 5 or at early termination. Blood pressure will be taken using a standardized automated cuff-based instrument (Omron HEM-907XL or equivalent). Qualified site personnel will program the machine to capture a series of 3 measurements of DBP starting with a 5-minute delay for the first reading followed by a delay of 2 minutes between the subsequent readings.
Measured: From baseline to study completion, approximately 12 weeks
Change in body weight, from baseline to study termination
BW measurements will be done without shoes or street clothing; subjects will be weighed in undergarments with gowns (front and back).
Measured: From baseline to study completion, approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start15 Oct 2026 (estimated)
- Primary completion2 May 2027 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuSirt Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647003
- Sponsor's protocol ID
- IND 168726
- Other IDs
- 1R44HL182451-01
- Acronym
- NS-HTN-01
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Two Fixed-Dose Leucine, Sildenafil and Metformin Combinations (NS-0200) Versus Placebo on Blood Pressure in Individuals With Hypertension
- ClinicalTrials.gov ID
- NCT07647003
- Acronym / sponsor ID
- NS-HTN-01 / IND 168726
- Conditions
- Hypertension
- Keywords
- Hypertension, High blood pressure, NS-0200, Leucine, Sildenafil, Metformin, Blood pressure, Randomized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NuSirt BiopharmaIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo3 tablets/dose orally BID (30 min before meals) |
| NS-0200 (low sildenafil) | Experimental | 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 |
| NS-0200 (higher sildenafil) | Experimental | 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 and ≤75 at study entry.
- Is male, or female and, if female, meets all of the following criteria: (1) Not breastfeeding; (2) Post-menopausal or negative serum pregnancy test result (human chorionic gonadotropin, beta subunit [β- hCG]) at screening (not required for hysterectomized females); (3) If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized or same sex partner) during the entire duration of the study Stable body weight (±5%) and health over the last 3 months.
- Systolic pressure > 130 mm Hg
- Not on antihypertensive therapy for the preceding 30 days or on a stable dose over the 30 days preceding study entry of 1 or 2 antihypertensive agents.
- HbA1c <9%.
Key exclusion criteria (23 listed)
- <18 or >75 years of age
- On >2 antihypertensive agent drug products
- Systolic pressure >160 mm Hg
- Diastolic pressure >110 mm Hg
- HbA1c >9% at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NS-0200 (low sildenafil)Also: TRIPLN (low sildenafil), TRIPLNTwo 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 (low sildenafil) |
| NS-0200 (higher sildenafil)Also: TRIPLN (higher sildenafil), TRIPLNTwo tablets 550 mg L-leucine + 250 mg metformin and one tablet 4.0 mg sildenafil per dose; 3 tablets/dose orally BID | Drug | NS-0200 (higher sildenafil) |
| Placebo9.5% 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 | Other | Placebo |
Primary outcome
Change in systolic blood pressure compared to placebo from baseline to study termination
Time frame: From baseline to study completion, approximately 12 weeks
Systolic blood pressure will be measured in all subjects at visits 1 through 5 or at early termination. BP will be taken using a standardized automated cuff-based instrument (Omron HEM-907XL or equivalent). Qualified site personnel will program the machine to capture a series of 3 measurements of SBP starting with a 5-minute delay for the first reading followed by a delay of 2 minutes between the subsequent readings.
2 secondary outcomes
Change in diastolic blood pressure compared to placebo from baseline to study termination
Time frame: From baseline to study completion, approximately 12 weeks
Change in body weight, from baseline to study termination
Time frame: From baseline to study completion, approximately 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NS-0200 (low sildenafil) and NS-0200 (higher sildenafil) in people with Hypertension, run by NuSirt Biopharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.