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Selective Estrogen Receptor Modulator

EDP-305 2 mg for Non-alcoholic Fatty Liver Disease

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
Informed consent documentation signed and dated by the participant.
Male and female participants, of all ethnic origins, between the ages of 18 and 75 years, inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 hours post dose at week 12
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have provided signed and dated consent documentation.
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You are between 18 and 75 years old, of either gender, and any ethnic background.
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Participants of all ethnic origins who had a BMI greater than 25 kg/m2 and not exceeding 45 were eligible for the study, with Asian participants being required to have a BMI of at least 23 kg/m2.
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You have histologically-confirmed, definite NASH according to the NASH Clinical Research Network criteria, as evaluated by a central histopathologist via liver biopsy taken either during screening or up to 26 weeks prior.
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You have an NAS of 4 or more, with a minimum score of 1 in each component (steatosis 0-3, lobular inflammation 0-3, ballooning 0-2).
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You have a diagnosis of fibrosis stage 2 or 3 according to the NASH CRN Histologic Scoring System.
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Participants had to present with negative results from tests for HBsAg, anti-HCV antibodies and HCV RNA, as well as Human Immunodeficiency Virus (HIV) 1 and 2 antibodies
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A woman who could become pregnant and was sexually active with a male had to agree to use two reliable forms of contraception from the date of Screening until 30 days after completion of study medication.
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Male participants who were sexually active with a woman of reproductive age needed to agree to use adequate contraception from the beginning of screening until 90 days after their last dose of study medication.
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Participants had to be committed and capable of adhering to the evaluations, appointments, prohibitions and limitations outlined in this protocol.
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This study is open to males and females between the ages of 18 and 75, regardless of ethnicity.
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With the exception of Asian individuals, all participants must have a BMI greater than 25 kg/m2 and 45 or above; for Asians, the required BMI is 23kg/m2 or higher.
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You have a NAS of 4 or greater with no component score less than 1.
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You must be able and willing to follow the assessments, visit schedules, prohibitions and constraints stipulated in this protocol.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
39 Previous Clinical Trials
2,886 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
2,250 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
509 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Maryland
North Carolina
How old are they?
18 - 65
65+
What site did they apply to?
Mid-Atlantic GI Research
Carolinas HealthCare System Digestive - Huntersville
What portion of applicants met pre-screening criteria?
Met criteria
~19 spots leftby Mar 2025