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Selective Estrogen Receptor Modulator

A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH

Phase 2
Waitlist Available
Research Sponsored by Enanta Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 hours post dose at week 12

Summary

This trial is testing a new drug to see if it's safe and effective for people with NASH, a type of liver disease.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-4 hours post dose at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-4 hours post dose at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants Who Achieve ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis and/or Resolution of Steatohepatitis and no Worsening of Liver Fibrosis as Determined by Liver Biopsy
Secondary study objectives
Change in 5D-itch Scale From Baseline
Change in Adiponectin From Baseline
Change in HDL From Baseline
+17 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP-305 2 mgExperimental Treatment1 Intervention
Once a day orally for 72 weeks
Group II: EDP-305 1.5 mgExperimental Treatment1 Intervention
Once a day orally for 72 weeks
Group III: PlaceboPlacebo Group1 Intervention
Once a day orally for 72 weeks

Find a Location

Who is running the clinical trial?

Enanta Pharmaceuticals, IncLead Sponsor
40 Previous Clinical Trials
3,023 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
509 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Enanta PharmaceuticalsLead Sponsor
33 Previous Clinical Trials
2,256 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
509 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~17 spots leftby Jan 2026
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