NCT05462353

Brief Summary

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
183

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

January 8, 2025

Status Verified

October 1, 2024

Enrollment Period

2.6 years

First QC Date

July 7, 2022

Last Update Submit

January 7, 2025

Conditions

Non-alcoholic Fatty Liver DiseaseNon-alcoholic Steatohepatitis

Keywords

Non-alcoholic Fatty Liver DiseaseNASHASC41Phase IITHR-β

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.

    A histological change in NAFLD (nonalcoholic fatty liver disease) Activity Score (NAS) ≥ 2 points that results from reduction of necroinflammation (inflammation or ballooning) without worsening fibrosis. (The NAFLD Activity Score including steatosis, inflammation and ballooning. The maximum score of steatosis was 3 and the minimum score was 0, the maximum score of inflammation was 3 and the minimum score was 0, and the maximum score of ballooning was 2 and the minimum score was 0. The higher scores mean a worse outcome. ）

    Baseline and Week 52

Secondary Outcomes (6)

  • The incidence, type and severity of AEs/SAEs were assessed by CTCAE v5.0 to assess the safety and tolerability of ASC41 compared to placebo

    24 and 52 weeks

  • Change from baseline in hepatic fat fraction assessed by MRI-PDFF

    24 and 52 weeks

  • To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL)

    12, 24 and 52 weeks

  • Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)

    1 and 15 Days

  • Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞)

    1 and 15 Days

  • +1 more secondary outcomes

Study Arms (3)

Cohort 1 Low Dose

EXPERIMENTAL

1 tablet of ASC41 (2 mg) for 52 weeks

Drug: 2mg of ASC41Drug: Placebo

Cohort 2 High Dose

EXPERIMENTAL

2 tablet of ASC41 (4 mg) for 52 weeks

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

Placebo tablet

PLACEBO COMPARATOR

Placebo tablet for 52 weeks

Drug: Placebo

Interventions

2mg of ASC41DRUG

ASC41 tablet administered orally once daily.

Cohort 1 Low Dose
4mg of ASC41 (2 tablets of 2 mg ASC41)DRUG

ASC41 tablets administered orally once daily.

Cohort 2 High Dose
PlaceboDRUG

Placebo tablets administered orally once daily.

Cohort 1 Low DosePlacebo tablet

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 18, 2022

Study Start

September 30, 2022

Primary Completion

May 10, 2025

Study Completion

June 10, 2025

Last Updated

January 8, 2025

Record last verified: 2024-10

Locations

CN(1)