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IKT-001 for Pulmonary Arterial Hypertension (PAH)

This study is testing a new medication called IKT-001 for people with Pulmonary Arterial Hypertension (PAH), a condition where blood pressure in the arteries of the lungs is too high. Researchers want to see if IKT-001 can improve lung blood vessel resistance and PAH symptoms compared to a placebo (an inactive pill). You might be able to join if you are between 18 and 75 years old and have a specific type of PAH (WHO Group 1). The study aims to enroll 486 participants. The current status of the study is unclear, so it's not known if they are actively recruiting.

Study design
This is a randomized, double-blind study with two parts, comparing IKT-001 to a placebo. It plans to include up to 486 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured up to Week 24 after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07365332

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Inhibikase Therapeutics
~486 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:IKT-001Placebo

At a glance

Recruiting sites
43 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
[Part A] To evaluate the effect on Pulmonary Vascular Resistance (PVR) in participants with WHO Group 1 PAH treated with IKT-001 compared to placebo
Measured over Baseline to Week 24
+1 more outcome measured

Conditions

Pulmonary Arterial Hypertension

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Pulmonary Arterial Hypertension

NCT07365332

Where you'd take part

This study runs at 43 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Amsterdam UMC site VUMC

    Amsterdam, North Holland, Netherlandsno site contact published

    Recruiting

  • Arizona Pulmonary Specialists, LTD

    Scottsdale, Arizonano site contact published

    Recruiting

  • Auckland City Hospital

    Auckland, Auckland, New Zealandno site contact published

    Recruiting

  • Cedars Sinai

    Beverly Hills, Californiano site contact published

    Recruiting

  • Chonnam National University Hospital

    Gwangju, South Koreano site contact published

    Recruiting

  • CHRU Strasbourg

    Strasbourg, Grand Est, Franceno site contact published

    Recruiting

  • Duke University

    Durham, North Carolinano site contact published

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Monza and Brianza, Italyno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Medical Director, Inhibikase Therapeutics
[email protected]
1-302-295-3800
Email the study team

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Eligibility criteria

Inclusion

Documented diagnosis of WHO PAH Group 1 in any of the following subtypes:
Idiopathic PAH
Heritable PAH
Drug/toxin-induced PAH
PAH associated with connective tissue disease (CTD)
PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
Men and women 18 and 75 years of age (inclusive)
Must have a body mass index (BMI) of ≥18.5 kg/m\^2 and ≤35.0 kg/m\^2 at screening.
Baseline RHC performed during the Screening Period documenting a PVR of ≥ 400 dyn/sec/cm\^5 ; pulmonary capillary wedge pressure (PCWP) ≤15 mmHg and mean pulmonary artery pressure (mPAP) \>20 mmHg. PVR enrichment criteria to ensure population baseline PVR \>700 dynes/sec/cm\^5
On stable doses of background PAH therapy including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, and soluble guanylate cyclase stimulators for ≥90 days prior to screening. Current use of sotatercept is not permitted.
6MWD ≥ 100 and ≤ 475 m

Exclusion

Diagnosis of PAH WHO Groups 2, 3, 4, or 5.
Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, and pulmonary veno-occlusive disease.
Any of the following blood pressure-related values or abnormalities: Uncontrolled systemic hypertension as evidenced by sitting systolic BP \>160 mmHg or sitting diastolic BP \>100 mmHg at screening, Baseline systolic BP \<90 mmHg at screening, Syncope within 3 months prior to screening
History of restrictive, constrictive, or congestive cardiomyopathy.
ECG with Fridericia's corrected QT interval (QTcF) ≥ 450 msec in males or ≥ 470 msec in females at screening or ≥500 msec in the presence of a right bundle branch block.
Personal or family history of long QT syndrome or sudden cardiac death.
Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device.
Forced vital capacity (FVC) \<70 percent on pulmonary function test (PFT) performed no more than 6 months prior to screening; or if FVC is 60 percent to 69 percent, must have a chest computed tomography scan within 12 months with no more than mild interstitial lung disease.
History of atrial fibrillation or atrial flutter.
History of cerebrovascular accident, intracranial hemorrhage, or subdural hematoma at anytime, or a fall associated with head trauma within 3 months of screening.
Acutely decompensated right heart failure within 30 days prior to screening, as per investigator assessment.
Clinically significant ischemic, valvular, constrictive heart disease, or heart failure with preserved ejection fraction in the opinion of the investigator.
History of pneumonectomy.
Untreated or inadequately treated (in the opinion of the investigator) obstructive sleep apnea.
Acute or chronic hepatitis B or C infection, defined as:
Hepatitis B virus: a positive hepatitis B surface antigen test or a positive hepatitis B core antibody test with detectable DNA
Hepatitis C virus (HCV): a positive hepatitis C antibody test with detectable HCV ribonucleic acid (RNA).Participants with a positive hepatitis C antibody test, but no detectable HCV RNA who completed treatment with direct-acting antivirals may be considered after discussion with the medical monitor.
History of or currently diagnosed with a bleeding disorder, including but not limited to hemophilia, von Willebrand disease, thrombocytopenia, or significant bleeding history defined as any bleeding event requiring medical intervention.
Received treatment with any of the following excluded medications:
Currently receiving strong cytochrome P450 (CYP) 3A inducers or CYP3A inhibitors (except for topical administration)
Currently receiving or anticipated need to receive any anticoagulant (e.g., heparins, vitamin K antagonists, direct oral anticoagulants, or direct thrombin inhibitors).
Current use of sotatercept. Note: participants who previously received sotatercept may be considered if the last dose administered was \>6 months prior to screening, participant had no significant bleeding events while on sotatercept.
Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to screening or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).
History of atrial septostomy within 180 days prior to screening.
Current participation in another investigational clinical trial and/or receipt of any investigational medication within 90 days prior to screening.
Previous randomization into this or another IKT-001 study.
Any social, behavioral, or medical reason that would preclude completion of the study, in the judgement of the investigator.
Currently lactating, pregnant or planning on becoming pregnant during the study.
Prior receipt of a solid organ transplant or stem cell transplant.
Planned surgery that would require any study drug interruption or interfere with study assessments during the study (minor procedures may be allowed in consultation with the medical monitor).
Malignancy within the last 5 years prior to consent except completely treated non-metastatic-basal cell, squamous cell, in situ cervical cancer, and clinically localized National Comprehensive Cancer Network very low to low risk prostate cancer under active surveillance.

What this trial measures

  • [Part A] To evaluate the effect on Pulmonary Vascular Resistance (PVR) in participants with WHO Group 1 PAH treated with IKT-001 compared to placeboBaseline to Week 24

    Change in Pulmonary Vascular Resistance (PVR)

  • [Part B] To characterize the effects of IKT-001 on symptoms and characteristics of Pulmonary Arterial Hypertension compared to placeboBaseline to Week 24

    Change in 6-minute walk distance (6MWD)