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NCT Number: NCT05462353

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Steatohepatitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2mg of ASC41

Drug

ASC41 tablet administered orally once daily.

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

Drug

ASC41 tablets administered orally once daily.

Placebo

Drug

Placebo tablets administered orally once daily.

Primary outcomes

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

    Time frame: Baseline and Week 52

    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. ）

Secondary outcomes

  1. 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

    Time frame: 24 and 52 weeks

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

    Time frame: 24 and 52 weeks

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

    Time frame: 12, 24 and 52 weeks

  4. Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)

    Time frame: 1 and 15 Days

    Measured after administration

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

    Time frame: 1 and 15 Days

  6. Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)

    Time frame: 1 and 15 Days

Sponsors and collaborators

Lead sponsor

Gannex Pharma Co., Ltd.

Industry

Registry information

Official study title

A Phase II, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Subjects With Nonalcoholic Steatohepatitis (NASH)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2022
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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