NCT05692492Active, not recruitingPhase 2
A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
A Randomized, Double-blind, Placebo-controlled Phase 2b Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Source: ClinicalTrials.gov · Last updated 19 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (actual)
- First submitted
- 25 Dec 2022
- Start date
- 3 Jun 2023
- Primary completion date
- 16 Jun 2026
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05692492
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 180
- From 3 Jun 2023 to the primary completion date, 16 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period
- 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
- Treatment with hepatoprotective drugs
- Excessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screening
Other illness
- History of cirrhosis or liver biopsy suggestive of cirrhosis
- Type 1 diabetes
- HIV infection
- Previous malignancy within 5 years
Lab values
- Pregnant and lactating women or those with a positive serum pregnancy test.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.