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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

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 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 (IPF Population)Placebo Group1 Intervention
Group VIII: Placebo (PPF Population)Placebo Group1 Intervention

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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