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

NCT06475781 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FP-045C-23-001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this clinical trial is to see if mirivadelgat will work in patients 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

Outcome Measures

Primary Outcomes (1)

• Pulmonary Vascular Resistance (PVR)

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

  12 weeks

Secondary Outcomes (6)

• 6-minute walk distance

  12 weeks

• Time to clinical deterioration from baseline to Week 12 for any of the following ADJUDICATED clinical events

  12 weeks

• Long-term prognostic risk factors

  12 weeks

• Patient-reported outcome measures (PROMS): (SF)-36v2

  12 weeks

• Patient-reported outcome measures (PROMS): WIQ

  12 weeks

Other Outcomes (10)

• Inflammatory markers

  12 weeks

• Cardiac MRI fibrosis score

  12 weeks

• Quantitative ILD features

  12 weeks

Study Arms (3)

150 mg mirivadelgat

EXPERIMENTAL

150 mg mirivadelgat once daily

Drug: Mirivadelgat

300 mg mirivadelgat

EXPERIMENTAL

300 mg mirivadelgat once daily

Drug: Mirivadelgat

placebo

PLACEBO COMPARATOR

placebo once daily

Drug: placebo

Interventions

Mirivadelgat DRUG

Selective aldehyde dehydrogenase 2 (ALDH2) activator

Also known as: FP-045

150 mg mirivadelgat; 300 mg mirivadelgat

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of PH-ILD.
• Subject voluntarily gives informed consent.
• Subjects aged between 18 and 85 years at the time of signing informed consent.
• Subjects must agree to practice protocol-defined birth control during the study period.
• Males with a partner of childbearing potential must practice protocol-defined birth control for the duration of treatment and at least 96 hours after discontinuing the IP.
• Female subjects of childbearing of potential (including those \<1-year post menopausal) must practice protocol-defined birth control during the conduct of the study and for 30 days after the last dose of IP (males only during exposure to IP).
• Women not of childbearing potential are defined as:
• Post-menopausal women (at least 12 months with no menses without an alternative medical cause); in women \<45 years of age, a high follicle-stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; OR
• Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR
• Have a congenital or acquired condition that prevents childbearing.
• The subject has a confirmed diagnosis of any form of interstitial lung disease based on high resolution computed tomography (HRCT) of the chest within 180 days prior to screening or at screening or a historical surgical biopsy (or other appropriate tissue sampling (e.g., cryobiopsy). The subject can have other findings (e.g., emphysema) if this is not the predominant feature on the scan.
• Subjects have undergone RHC during the screening period with the following documented parameters:
• Pulmonary vascular resistance (PVR) ≥4 Wood units and
• Pulmonary capillary wedge pressure (PCWP) of ≤12 mmHg \[if PVR ≥4 Wood units to \<6.25 Wood units\] or PCWP ≤15 mmHg \[if PVR ≥6.25 Wood units\] (a left ventricular end diastolic pressure \[LVEDP\] will be acceptable if a reliable PCWP cannot be obtained) and
• A mean pulmonary arterial pressure (PAP) of \>20 mmHg.

You may not qualify if:

• Medical Conditions
• Subject has another concomitant diagnosis of pulmonary hypertension not otherwise considered to be PH-ILD. This would include and is not limited to the concomitant presence of thromboembolic disease, untreated/inadequately treated obstructive sleep apnea, human immunodeficiency virus (HIV), methamphetamine or anorexigenic drug use, and other conditions of the WHO Group 1, 2, 4, and 5 classifications.
• Subject has evidence of clinically significant left-sided heart disease within 6 months as defined by:
• Left ventricular ejection fraction \<40% as assessed by echocardiography.
• More than mild left-sided valvulopathy (e.g., worse than mild mitral stenosis or regurgitation and worse than mild aortic stenosis or regurgitation).
• LVEDP or PCWP \>15 mmHg (or \>12 mmHg if PVR ≥4 to 6.25 Wood units).
• Subjects must NOT have 3 or more of the following left ventricular disease/dysfunction risk factors at screening:
• Body mass index (BMI) ≥30 kg/m2.
• Uncontrolled diabetes, HbA1C \>9.5%, urine glycosuria \>1.0 g/dl, or presence of diabetic ketoacidosis
• History of significant coronary disease within 6 months of screening as demonstrated by any of the following:
• History of myocardial infarction or acute coronary syndrome (unstable angina), or
• Percutaneous coronary intervention or percutaneous transluminal angioplasty, or previous coronary artery bypass graft, or
• Evidence of coronary artery disease (\>50% stenosis in at least one major coronary artery) or abnormal nuclear stress test.
• The subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest.
• The subject has received any PH-approved therapy, including phosphodiesterase type 5 inhibitor, soluble guanylate cyclase inhibitor, endothelin receptor antagonist, or parenteral or oral prostacyclin therapy (excluding vasoreactivity testing) within 60 days of randomization or 5 half-lives. Inhaled prostacyclin (e.g., inhaled treprostinil) on stable doses for ≥30 days prior to screening will be allowed irrespective of local approval (as per ESC/ERS 2022).

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead
• QPS-Qualitix Clinical Research Co., Ltd: collaborator

Study Sites (9)

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

RECRUITING

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

MacKay Memorial Hospital

Taipei, 104, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan, Taiwan

RECRUITING

Study Officials

• Bassem Elmankabadi, MD

  Foresee Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Bassem Elmankabadi, MD

CONTACT

+1 562-310-8718; Bassem.elmankabadi@foreseepharma.com

Yisheng Lee, MD

CONTACT

408-823-4807; yisheng.lee@foreseepharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug will be provided in wallet cards. The wallet cards will have unique numbering and will be assigned by an interactive web response system (IWRS). The capsules containing active drug and the placebo capsules will have the same appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 26, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (9)