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

NCT06475781 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-10-06

No results posted yet for this study

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

Interventions

DRUG

Mirivadelgat

Selective aldehyde dehydrogenase 2 (ALDH2) activator

DRUG

placebo

placebo

Sponsors & Collaborators

  • QPS-Qualitix Clinical Research Co., Ltd

    collaborator UNKNOWN

  • Foresee Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Bassem Elmankabadi, MD · Foresee Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2028-06-30
Completion
2028-08-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06475781 on ClinicalTrials.gov