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

G

Gannex Pharma

Status and phase

Active, not recruiting
Phase 2

Conditions

Non-alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05462353
ASC41-202

Details and patient eligibility

About

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).

Enrollment

183 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

183 participants in 3 patient groups, including a placebo group

Cohort 1 Low Dose
Experimental group
Description:
1 tablet of ASC41 (2 mg) for 52 weeks
Treatment:
Drug: Placebo
Drug: 2mg of ASC41
Cohort 2 High Dose
Experimental group
Description:
2 tablet of ASC41 (4 mg) for 52 weeks
Treatment:
Drug: 4mg of ASC41 (2 tablets of 2 mg ASC41)
Placebo tablet
Placebo Comparator group
Description:
Placebo tablet for 52 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

ling Gong, Doctor; Junping Shi, Doctor

Data sourced from clinicaltrials.gov

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