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Studies

Interventional Recruiting Phase 2

NCT06475781 on ClinicalTrials.gov

Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward)

Official title: A Multinational Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Mirivadelgat, an Aldehyde Dehydrogenase 2 Activator, in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

  • Sponsor: Foresee Pharmaceuticals Co., Ltd.
  • Collaborators: QPS Holdings LLC
  • Enrollment: 126 (Estimated)
  • Study start: 2025-03-01 (Actual)
  • Primary completion: 2028-02-01 (Estimated)
  • Study completion: 2028-02-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

The goal of this clinical trial is to see if mirivadelgat will work in participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). It will also learn about the safety of mirivadelgat. The main question it aims to answer is if mirivadelgat will improve pulmonary vascular resistance (PVR). Pulmonary vascular resistance is a way to measure blood flow in the lungs.

Researchers will compare mirivadelgat to a placebo (a look-alike capsule that contains no drug) to see if mirivadelgat works to improve the symptoms of PH-ILD. The symptoms of PH-ILD that are being looked at are exercise tolerance, heart function, and general well-being.

Participants will:

Take mirivadelgat or a placebo once a day for 12 weeks

Visit the clinic once every 4 weeks for checkups and tests

Receive phone calls every one or two weeks to check on how things are going

Conditions

  • Group 3 Pulmonary Hypertension

Intervention / Treatment

  • Drug: Mirivadelgat
  • Drug: placebo

Primary Outcome Measures

  • Pulmonary Vascular Resistance (PVR) (12 weeks)
    The mean change from baseline to Week 12 in PVR assessed by right heart catheterization (RHC) for mirivadelgat vs. placebo.

Countries

Bosnia and Herzegovina, Taiwan

Locations and Investigators

  • University Clinical Centre of the Republic of Srpska, Banja Luka, Bosnia and Herzegovina (Not yet recruiting)
  • Clinical Center of the University of Sarajevo, Sarajevo, Bosnia and Herzegovina (Not yet recruiting)
  • Hualien Tzu Chi Hospital, Hualien City, Taiwan (Recruiting)
    • Wei-Tung Lin
    • Wei-Hsin Liu, M.D. (Principal Investigator)
  • Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan (Terminated)
  • Taichung Veterans General Hospital, Taichung, Taiwan (Recruiting)
    • Hui-Chih Yang
    • Pin-Kuei Fu, M.D. (Principal Investigator)
  • National Cheng Kung University Hospital, Tainan, Taiwan (Terminated)
  • National Taiwan University Hospital, Taipei, Taiwan (Recruiting)
    • Sui-Han Chen
    • Ping-Hung Kuo, M.D. (Principal Investigator)
  • Taipei Veterans General Hospital, Taipei, Taiwan (Recruiting)
  • Chang Gung Memorial Hospital - Linkou Branch, Taoyuan City, Taiwan (Recruiting)
    • Yi-Ping Chi
    • Wan-Jing Ho, M.D. (Principal Investigator)
  • Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan (Terminated)
  • MacKay Memorial Hospital, Taipei, Taiwan (Recruiting)
    • Yu-Ping Huang
    • Yih-Jer Wu, MD (Principal Investigator)

Study Officials

  • Bassem Elmankabadi, MD (Study Director) — Foresee Pharmaceuticals