Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2025-06-10

Brief Summary

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This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).

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Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1 Low Dose

1 tablet of ASC41 (2 mg) for 52 weeks

Group Type EXPERIMENTAL

2mg of ASC41

Intervention Type DRUG

ASC41 tablet administered orally once daily.

Placebo

Intervention Type DRUG

Placebo tablets administered orally once daily.

Cohort 2 High Dose

2 tablet of ASC41 (4 mg) for 52 weeks

Group Type EXPERIMENTAL

4mg of ASC41 (2 tablets of 2 mg ASC41)

Intervention Type DRUG

ASC41 tablets administered orally once daily.

Placebo tablet

Placebo tablet for 52 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets administered orally once daily.

Interventions

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2mg of ASC41

ASC41 tablet administered orally once daily.

Intervention Type DRUG

4mg of ASC41 (2 tablets of 2 mg ASC41)

ASC41 tablets administered orally once daily.

Intervention Type DRUG

Placebo

Placebo tablets administered orally once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 and ≤ 80 years old at screening.
* Presence of ≥ 7.5% steatosis on screening MRI-PDFF read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit.
* HbA1c ≤ 9.5%.
* Normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m\^2

Exclusion Criteria

* Presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma.
* History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings.
* Uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c of \> 9.5% within 60 days prior to enrollment.
* Change in anti-diabetic therapy within 6 months prior to qualifying liver biopsy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No