NCT06422884

A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)

A Phase 2, Multi-Center, Randomized, Double-Blind, Controlled Trial Evaluating the Safety and Efficacy of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Endeavor Biomedicines, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the impact that ENV-101 has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF). Another goal of this study is to better understand the safety and tolerability of ENV-101 in this patient population.

Detailed description

This trial is a 6-month, randomized, double-blind, controlled, dose-ranging trial of ENV-101 in adult patients with idiopathic pulmonary fibrosis (IPF). Patients are allowed to continue treatment with approved standard of care (e.g., nintedanib, pirfenidone) during the trial. Patients will be randomized to one of 3 dose levels of ENV-101 or placebo at baseline. The objectives of this trial are to characterize the efficacy, antifibrotic activity, and safety of ENV-101 to select the Phase 3 dose of ENV-101.

Conditions

• Idiopathic Pulmonary Fibrosis
• Progressive Fibrosing Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	ENV-101	oral tablet, dosed once a day
DRUG	Placebo	oral tablet, dosed once a day

Timeline

• Start date: 2024-11-15
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-05-21
• Last updated: 2026-02-24

Locations

78 sites across 14 countries: Argentina, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Malaysia, Mexico, New Zealand, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study