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Anti-fibrotic Agent

ENV-101 for Pulmonary Fibrosis

Phase 2

Waitlist Available

Research Sponsored by Endeavor Biomedicines, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

IPF Population: Patients ≥ 40 years old with an IPF diagnosis as confirmed by the Investigator

Ability to perform spirometry tests

Must not have

Patients who have previously taken ENV-101

Occurrence of serious illness requiring hospitalization within 90 days prior to study start

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 24

Awards & highlights

Summary

This trial aims to see how a drug called ENV-101 affects lung function and fibrosis in adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It

Who is the study for?

Adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) are eligible for this trial. Specific criteria will determine who can join, but the main requirement is a diagnosis of lung fibrosis.

What is being tested?

The WHISTLE-PF Trial is testing ENV-101's effects on lung function and fibrosis in patients compared to a placebo. The study aims to understand how well ENV-101 works and its safety.

What are the potential side effects?

While specific side effects aren't listed, common ones for treatments like ENV-101 may include gastrointestinal issues, skin reactions, fatigue, and potential liver enzyme abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 or older and have been diagnosed with IPF.

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I can perform breathing tests.

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I am an adult diagnosed with PPF.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously taken ENV-101.

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I have not been hospitalized for a serious illness in the last 3 months.

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I haven't had major surgery in the last 3 months nor plan to during the trial.

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My lung condition is not caused by known ILD reasons.

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I do not have an active infection or confirmed HIV, HBV, or HCV at the start of the study.

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My liver function is significantly impaired.

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I am not pregnant or nursing.

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I agree not to donate sperm/eggs during and for 3 months after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IPF Population Primary Endpoint: Rate of change in percent predicted forced vital capacity (ppFVC) compared to placebo

PPF Population Primary Endpoint: Safety

Secondary study objectives

Absolute change in FVC (mL) compared to placebo

Absolute change in the L-PF Symptoms Questionnaire Dyspnea domain score compared to placebo

Absolute change in the L-PF Symptoms Questionnaire Fatigue domain score compared to placebo

+2 more

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: ENV-101 Mid Dose (PPF Population)Experimental Treatment1 Intervention

Group II: ENV-101 Mid Dose (IPF Population)Experimental Treatment1 Intervention

Group III: ENV-101 Low Dose (PPF Population)Experimental Treatment1 Intervention

Group IV: ENV-101 Low Dose (IPF Population)Experimental Treatment1 Intervention

Group V: ENV-101 High Dose (PPF Population)Experimental Treatment1 Intervention

Group VI: ENV-101 High Dose (IPF Population)Experimental Treatment1 Intervention

Group VII: Placebo (PPF Population)Placebo Group1 Intervention

Group VIII: Placebo (IPF Population)Placebo Group1 Intervention

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Endeavor Biomedicines, Inc.Lead Sponsor

3 Previous Clinical Trials

106 Total Patients Enrolled

2 Trials studying Idiopathic Pulmonary Fibrosis

62 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Paul Frohna, M.D., Ph.D., Pharm.D.Study DirectorEndeavor Biomedicines

~213 spots leftby Jun 2026

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