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

• Sponsor: Guangdong Raynovent Biotech Co., Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05692492
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 46.5
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nonalcoholic Steatohepatitis (NASH)	Drug: ZSP1601; Drug: ZSP1601; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Phase 2b Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Jun 16, 2026
• Anticipated Study Completion Date: Dec 16, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ZSP1601 50mg BID	Drug: ZSP1601; 50mg BID
Experimental: ZSP1601 100 mg BID	Drug: ZSP1601; 100mg BID
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Percent of patients with improvement of steatohepatitis and no worsening of liver fibrosis or improvement in liver fibrosis greater than or equal to one stage and no worsening of the steatohepatitis [48 weeks]

   Percent of patients with improvement of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH-CRN Fibrosis Score or improvement in liver fibrosis greater than or equal to one stage and no worsening of the steatohepatitis

Secondary Outcome Measures

1. Percent of patients with resolution of steatohepatitis and no worsening of fibrosis or improvement of fibrosis by at least 1 stage and no worsening of steatohepatitis [48 weeks]

2. Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage [48 weeks]

3. Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage [48 weeks]

4. Percent of patients with steatohepatitis resolution and no worsening of fibrosis [48 weeks]

5. Percent of patients with steatohepatitis improvement and no worsening of fibrosis [48 weeks]

6. Change from baseline in liver fat content (LFC) as measured by MRI-PDFF [48 weeks]

7. Change from baseline in liver chemistry（ALT,AST,GGT） [48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NanFang Hospital	Guangzhou		China

Sponsors and Collaborators

• Guangdong Raynovent Biotech Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guangdong Raynovent Biotech Co., Ltd
• ClinicalTrials.gov Identifier: NCT05692492
• Other Study ID Numbers: ZSP1601-22-03
• First Posted: Jan 20, 2023
• Last Update Posted: Jan 20, 2023
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Jan 20, 2023