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Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)

NCT07441200•NS Pharma, Inc.

View on ClinicalTrials.gov

Summary

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Arterial Hypertension (PAH)

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability to provide written informed consent prior to participation in the trial, which includes the ability to comply with the requirements and restrictions listed in the informed consent form (ICF). Participants must be able to read, comprehend, and write at a level sufficient to complete trial-related materials
•Adult male or female participants 18 to 75 years of age at the time the ICF is signed
•Diagnosed with Group 1 PAH and pre-capillary PH defined by RHC during or at any time prior to the Screening Visit in any of the following subtypes:
•1. Idiopathic PAH (IPAH)
•2. Heritable PAH (HPAH)
•3. PAH associated drug and toxins (DPAH)
•4. PAH associated with connective tissue disease (PAH-CTD)
•5. PAH associated with congenital heart disease (PAH-CHD); simple systemic to pulmonary shunt at least 6 months after surgical repair
•Diagnosed as WHO FC II, III, or IV on stable background therapy
•Results of the RHC within 35 days prior to Day 1 and meet all of the following criteria:
+5 more criteria

Exclusion Criteria

•Current diagnosis of the following PAH Group 1 subtypes:
•1. PAH associated with human immunodeficiency virus (HIV) infection
•2. PAH associated with portal hypertension
•3. PAH associated with schistosomiasis
•4. PAH with features of venous/capillary involvement
•5. Eisenmenger syndrome and PAH associated with prevalent systemic to pulmonary shunts in PAH-CHD
•Have ≥3 of the following LV disease/dysfunction risk factors. :
•1. Body mass index (BMI) ≥30 kg/m2 at the Screening Visit
•2. History of essential hypertension
•3. Diabetes mellitus (any type)
+21 more criteria

Key Dates

Start Date

July 1, 2026

Primary Completion Date

August 1, 2028

Completion Date

November 1, 2028

Last Updated

February 27, 2026

Enrollment

135

ESTIMATED participants

Conditions

Pulmonary Arterial Hypertension

Interventions

NS-863 Low Dose

DRUG

NS-863 High Dose

DRUG

NS-863 Placebo

DRUG

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

View study

RECRUITINGPHASE3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization