Non-Alcoholic Steatohepatitis (NASH)Phase 2NCT06168383
To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) .
A Phase 2 study testing HSK31679 80mg and HSK31679 160mg in people with Non-Alcoholic Steatohepatitis (NASH), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
A double-blind placebo controlled, randomized, Phase 2b study to evaluate the efficacy and safety of once-daily, oral administration of 80 or 160 mg HSK31679 versus matching placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Alcoholic Steatohepatitis (NASH)
- What is being tested?
- HSK31679 80mg and HSK31679 160mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2024to 16 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be willing to participate in the study and provide written informed consent.
- Male or female aged 18 ≤ age < 75 at the time of signing the informed consent
- Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 2 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration.
- Must have confirmation of ≥8% liver fat content on MRI-PDFF.
- Weight changes≤5% in the 6 weeks prior to randomization.If a historical biopsy is to be used, patients must have had weight changed≤5%, too.
Who cannot join
- History or presence of cirrhosis，hepatic decompensation or impairment defined as presence of any of the following: history of esophageal varices, ascites, or hepatic encephalopathy, or hepatocellular carcinoma.
- Use of high dose vitamin E (>400 IU/day)，polyunsaturated fatty acid or ursodeoxycholic acid unless stable for ≥6 months prior to an eligible screening liver biopsy. Use of thiazolidinediones, sodium-glucose co-transporter 2 inhibitors or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) unless stable for ≥3 months prior to an eligible screening liver biopsy.
- Use of Glucagon-like peptide 1 [GLP-1] agonist therapy (e.g.,liraglutide, semaglutide, dulaglutide and exenatide ) within 6 months prior to an eligible screening liver biopsy.
- Use of drugs that have the potential to affect thyroid hormone production and/or interfere with thyroid function.
- Potent inhibitors of CYP2C8 such as gemfibrozil and trimethoprim are prohibited. An inducer of CYP2C8, rifampicin, is prohibited.
- Use of drugs historically associated with NAFLD/NASH for 2 weeks prior to an eligible screening liver biopsy, which include, but are not limited, to the following: total parenteral nutritionamiodarone, methotrexate, systemic glucocorticoids (if use within 3 months prior to a biopsy is also not permitted), tamoxifen, tetracycline, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids , valproic acid, and known hepatotoxins.
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- Regular use of drugs historically associated with NAFLD/NASH within 12 months prior to liver biopsy (including historical biopsy), which include, but are not limited, to the following:PPAR agonists (e.g. lanifibranor, Siglitazone sodium) ，FXR agonists (e.g., obecholic acid, HTD1801)，FGF21 analogs (e.g., AP025, efruxifermin , pegozafermin(B1089-1001)) ; DGAT2 inhibitors (e.g., PF 6865571 and ION224),PDE inhibitors (e.g., ZSP1601) and other thyroid hormone receptor B agonists [e.g.,resmetirom（MGL-3196）、ASC41 and VK2809).
- Lipid-lowering therapy that did not meet the following criteria: fenofibrate, ezetimibe stable for at least 3 months before randomization and remained unchanged during study treatment, and statins stable for at least 4 weeks before randomization and remained unchanged during study treatment.
- Type 1 diabetes or uncontrolled Type 2 diabetes defined as:
- Hemoglobin A1c >9.5% at screening (patients with HbA1c >9.5% may be rescreened),
- Insulin dose adjustment >20% within 60 days prior to enrollment,
- Requirement for glucagon-like peptide analogue (unless on a stable dose ≥ 6 months prior to screening) or History of severe hypoglycemia (symptomatic hypoglycemia requiring outside assistance to regain normal neurologic status).
- Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure >160 mmHg or a diastolic blood pressure >100 mmHg at screening.
- Evidence of other forms of chronic liver disease including the following:biliary bypass, drug induced liver disease, alcoholic liver disease, autoimmune hepatitis, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hemohemosis, Wilson's disease, α-1 antitrypsin deficiency, bile duct obstruction, primary or metastatic liver cancer, hepatitis B, or present Hepatitis virus (HCV) infection.
- Thyroid diseases: hyperthyroidism and hypothyroidism. Thyroid peroxidase antibodies (TPOAb) or thyroglobulin antibodies (TGAb) that have been determined by the investigators to be clinically significant.
- Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months prior to screening.
- New York Heart Association class III or IV heart failure, or known left ventricular ejection fraction <30%.
- Serum ALT or AST >5 × ULN; Serum ALP≥2× ULN；eGFR<60 mL/min/1.73m2；INR>1.5× ULN；platelets < 80×109/L.
- Participation in an investigational new drug trial in the 90 days prior to randomization.
- Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Placebo Randomized , Phase2b Study to Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH).
A double-blind placebo controlled, randomized, Phase 2b study to evaluate the efficacy and safety of once-daily, oral administration of 80 or 160 mg HSK31679 versus matching placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis.
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Being tested
- HSK31679 80mg, HSK31679 160mg, 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.
HSK31679 80mgDrug
once daily, oral administration of HSK31679 80mg from Day 1 to Week 52.
HSK31679 160mgDrug
once daily, oral administration of HSK31679 160mg from Day 1 to Week 52.
PlaceboDrug
once daily, oral administration of placebo from Day 1 to Week 52.
| Study group | Role | What they receive |
|---|---|---|
| Double-blind 80 mg Daily | Experimental | Patients take double-blind HSK31679 80 mg for 52 weeks Receives: Drug: HSK31679 80mg |
| Double-blind 160 mg Daily | Experimental | Patients take double-blind HSK31679 160 mg for 52 weeks Receives: Drug: HSK31679 160mg |
| Placebo | Placebo comparator | Patients take double-blind placebo for 52 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of patients(HSK31679-treated versus placebo-treated) with NASH improvement and with no worsening of fibrosis at week 52 compared with Baseline.
Improvement of NASH is defined as a 2-point reduction in NAS with at least 1-point reduction in ballooning and no increase in steatosis.
Measured: from Baseline to 52 weeks
Secondary outcomes (5)
Proportions of patients(HSK31679-treated versus placebo-treated) with improvement in liver fibrosis greater than or equal to one stage and no worsening of NASH at week 52 compared with Baseline.
Measured: from Baseline to 52 weeks
Proportions of patients(HSK31679-treated versus placebo-treated) with both improvement of NASH and fibrosis at week 52 compared with Baseline.
Measured: from Baseline to 52 weeks
The percent relative change from baseline in hepatic fat fraction by MRI-PDFF at 12, 24, 36 and 52 weeks for HSK31679 versus placebo.
Measured: from Baseline to 12, 24, 36, and 52 weeks
The proportions of patients with 30% or more relative hepatic fat reduction at 12 , 24 , 36 and 52 weeks for HSK31679 versus placebo.
Measured: from Baseline to 12, 24, 36, and 52 weeks
Assess the effect of HSK31679 compared to placebo on Parameters of blood lipids measured by percent change from Baseline to 12, 24, 36, and 52 weeks.
Measured: from Baseline to 12, 24, 36, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start5 Jan 2024
- Primary completion12 Dec 2025
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168383
- Sponsor's protocol ID
- HSK31679-202
- Status last verified
- Jun 2026
- First submitted
- 5 Dec 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xue F, Liu J, Chen J, Li X, Wang S, Luo Y, Zhang B, Geng J, Wang W, Zhao R, Zhu C, Bi J, Guo X, Lu L, Li G, Peng H, Dong L, Zeng W, Wu T, Li F, Wei L; Simedeutirom-202 Trial Investigators. Thyroid hormone receptor-beta agonist simedeutirom (HSK31679) for Chinese patients with metabolic dysfunction-associated steatohepatitis: a 52-week, multicentre, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2026 Oct 16:S2468-1253(26)00243-8. doi: 10.1016/S2468-1253(26)00243-8. Online ahead of print.
PubMed 42887516
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo Randomized , Phase2b Study to Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH).
- ClinicalTrials.gov ID
- NCT06168383
- Acronym / sponsor ID
- HSK31679-202
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 13 Dec 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.
A double-blind placebo controlled, randomized, Phase 2b study to evaluate the efficacy and safety of once-daily, oral administration of 80 or 160 mg HSK31679 versus matching placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double-blind 80 mg Daily | Experimental | Drug: HSK31679 80mgPatients take double-blind HSK31679 80 mg for 52 weeks |
| Double-blind 160 mg Daily | Experimental | Drug: HSK31679 160mgPatients take double-blind HSK31679 160 mg for 52 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPatients take double-blind placebo for 52 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be willing to participate in the study and provide written informed consent.
- Male or female aged 18 ≤ age < 75 at the time of signing the informed consent
- Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 2 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration.
- Must have confirmation of ≥8% liver fat content on MRI-PDFF.
- Weight changes≤5% in the 6 weeks prior to randomization.If a historical biopsy is to be used, patients must have had weight changed≤5%, too.
Key exclusion criteria (20 listed)
- History or presence of cirrhosis，hepatic decompensation or impairment defined as presence of any of the following: history of esophageal varices, ascites, or hepatic encephalopathy, or hepatocellular carcinoma.
- Use of high dose vitamin E (>400 IU/day)，polyunsaturated fatty acid or ursodeoxycholic acid unless stable for ≥6 months prior to an eligible screening liver biopsy. Use of thiazolidinediones, sodium-glucose co-transporter 2 inhibitors or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) unless stable for ≥3 months prior to an eligible screening liver biopsy.
- Use of Glucagon-like peptide 1 [GLP-1] agonist therapy (e.g.,liraglutide, semaglutide, dulaglutide and exenatide ) within 6 months prior to an eligible screening liver biopsy.
- Use of drugs that have the potential to affect thyroid hormone production and/or interfere with thyroid function.
- Potent inhibitors of CYP2C8 such as gemfibrozil and trimethoprim are prohibited. An inducer of CYP2C8, rifampicin, is prohibited.
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 |
|---|---|---|
| HSK31679 80mgonce daily, oral administration of HSK31679 80mg from Day 1 to Week 52. | Drug | Double-blind 80 mg Daily |
| HSK31679 160mgonce daily, oral administration of HSK31679 160mg from Day 1 to Week 52. | Drug | Double-blind 160 mg Daily |
| Placeboonce daily, oral administration of placebo from Day 1 to Week 52. | Drug | Placebo |
Primary outcome
Proportions of patients(HSK31679-treated versus placebo-treated) with NASH improvement and with no worsening of fibrosis at week 52 compared with Baseline.
Time frame: from Baseline to 52 weeks
Improvement of NASH is defined as a 2-point reduction in NAS with at least 1-point reduction in ballooning and no increase in steatosis.
5 secondary outcomes
Proportions of patients(HSK31679-treated versus placebo-treated) with improvement in liver fibrosis greater than or equal to one stage and no worsening of NASH at week 52 compared with Baseline.
Time frame: from Baseline to 52 weeks
Proportions of patients(HSK31679-treated versus placebo-treated) with both improvement of NASH and fibrosis at week 52 compared with Baseline.
Time frame: from Baseline to 52 weeks
The percent relative change from baseline in hepatic fat fraction by MRI-PDFF at 12, 24, 36 and 52 weeks for HSK31679 versus placebo.
Time frame: from Baseline to 12, 24, 36, and 52 weeks
The proportions of patients with 30% or more relative hepatic fat reduction at 12 , 24 , 36 and 52 weeks for HSK31679 versus placebo.
Time frame: from Baseline to 12, 24, 36, and 52 weeks
Assess the effect of HSK31679 compared to placebo on Parameters of blood lipids measured by percent change from Baseline to 12, 24, 36, and 52 weeks.
Time frame: from Baseline to 12, 24, 36, and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 42887516Xue F, Liu J, Chen J, Li X, Wang S, Luo Y, Zhang B, Geng J, Wang W, Zhao R, Zhu C, Bi J, Guo X, Lu L, Li G, Peng H, Dong L, Zeng W, Wu T, Li F, Wei L; Simedeutirom-202 Trial Investigators. Thyroid hormone receptor-beta agonist simedeutirom (HSK31679) for Chinese patients with metabolic dysfunction-associated steatohepatitis: a 52-week, multicentre, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2026 Oct 16:S2468-1253(26)00243-8. doi: 10.1016/S2468-1253(26)00243-8. Online ahead of print.
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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 HSK31679 80mg and HSK31679 160mg in people with Non-Alcoholic Steatohepatitis (NASH), run by Haisco Pharmaceutical Group 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 5 inclusion and 20 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: finished, as of the sponsor's last update on 23 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportions of patients(HSK31679-treated versus placebo-treated) with NASH improvement and with no worsening of fibrosis at week 52 compared with Baseline. (time frame: from Baseline to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06168383, which also lists 1 linked publication.
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 23 Jun 2026.