A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

Guangdong Raynovent Biotech

Status and phase: Active, not recruiting; Phase 2

Conditions: Nonalcoholic Steatohepatitis (NASH)

Treatments: Drug: ZSP1601; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05692492

ZSP1601-22-03

Details and patient eligibility

About

The purpose of this research is to evaluate the efficacy and the safety of two doses of ZSP1601 for 48 weeks versus placebo in adult NASH patients.

Enrollment: 180 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. NASH histological diagnosis on a liver biopsy performed ≤ 24 weeks before randomization, and NAS≥4 (at least 1 point each in inflammation and ballooning), and fibrosis score F2 or F3, and no other chronic liver disease
2. Subjects having given her/his written informed consent
3. Good compliance with the protocol and agree to have liver biopsy performed
4. Subjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuation

Exclusion criteria

1. History of cirrhosis or liver biopsy suggestive of cirrhosis
2. Metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period
3. Type 1 diabetes
4. HIV infection
5. Patients with severe or uncontrollable underlying diseases, unsuitable for treatment with ZSP1601, unable to complete study follow-up, or likely to affect the evaluation of trial results judged by investigator
6. Previous malignancy within 5 years
7. Treatment with hepatoprotective drugs
8. Excessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screening
9. Pregnant and lactating women or those with a positive serum pregnancy test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

ZSP1601 50mg BID

Experimental group

Treatment:

Drug: ZSP1601

Drug: ZSP1601

ZSP1601 100 mg BID

Experimental group

Treatment:

Drug: ZSP1601

Drug: ZSP1601

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo