Nonalcoholic Steatohepatitis (NASH)Phase 2NCT05692492
A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study testing ZSP1601 in people with Nonalcoholic Steatohepatitis (NASH), run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH)
- What is being tested?
- ZSP1601
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2023to 16 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Subjects having given her/his written informed consent
- Good compliance with the protocol and agree to have liver biopsy performed
- Subjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuation
Who cannot join
- History of cirrhosis or liver biopsy suggestive of cirrhosis
- Metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period
- Type 1 diabetes
- HIV infection
- 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
- Previous malignancy within 5 years
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- Treatment with hepatoprotective drugs
- Excessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screening
- Pregnant and lactating women or those with a positive serum pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2b Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
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.
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- ZSP1601, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSP1601Drug
50mg BID
ZSP1601Drug
100mg BID
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ZSP1601 50mg BID | Experimental | Not described Receives: Drug: ZSP1601 |
| ZSP1601 100 mg BID | Experimental | Not described Receives: Drug: ZSP1601 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 48 weeks
Secondary outcomes (7)
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
Measured: 48 weeks
Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage
Measured: 48 weeks
Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage
Measured: 48 weeks
Percent of patients with steatohepatitis resolution and no worsening of fibrosis
Measured: 48 weeks
Percent of patients with steatohepatitis improvement and no worsening of fibrosis
Measured: 48 weeks
Change from baseline in liver fat content (LFC) as measured by MRI-PDFF
Measured: 48 weeks
Change from baseline in liver chemistry（ALT,AST,GGT）
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start3 Jun 2023
- Primary completion16 Jun 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692492
- Sponsor's protocol ID
- ZSP1601-22-03
- Status last verified
- Mar 2025
- First submitted
- 25 Dec 2022
- Last updated
- 19 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 2b Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT05692492
- Acronym / sponsor ID
- ZSP1601-22-03
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 16 Jun 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZSP1601 50mg BID | Experimental | Drug: ZSP1601 |
| ZSP1601 100 mg BID | Experimental | Drug: ZSP1601 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Subjects having given her/his written informed consent
- Good compliance with the protocol and agree to have liver biopsy performed
- Subjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuation
Key exclusion criteria (9 listed)
- History of cirrhosis or liver biopsy suggestive of cirrhosis
- Metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period
- Type 1 diabetes
- HIV infection
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZSP160150mg BID | Drug | ZSP1601 50mg BID |
| ZSP1601100mg BID | Drug | ZSP1601 100 mg BID |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
Time frame: 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
7 secondary outcomes
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
Time frame: 48 weeks
Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage
Time frame: 48 weeks
Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage
Time frame: 48 weeks
Percent of patients with steatohepatitis resolution and no worsening of fibrosis
Time frame: 48 weeks
Percent of patients with steatohepatitis improvement and no worsening of fibrosis
Time frame: 48 weeks
Change from baseline in liver fat content (LFC) as measured by MRI-PDFF
Time frame: 48 weeks
Change from baseline in liver chemistry（ALT,AST,GGT）
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZSP1601 in people with Nonalcoholic Steatohepatitis (NASH), run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.