NASH - Nonalcoholic SteatohepatitisPhase 2NCT03868566
An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD
A Phase 2 study testing SNP-612 dose1 and SNP-612 dose2 in people with NASH - Nonalcoholic Steatohepatitis, run by Sinew Pharma Inc. at 1 site in Taiwan.
Trial summary
The primary objective of the study is to compare the changes in ALT to baseline among patients with non-alcoholic fatty liver disease (NAFLD) following the 3-month treatment of 3 different dosing regimens of SNP-612. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- SNP-612 dose1 and SNP-612 dose2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Aug 2017to 19 Oct 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years
- Body weight ≥ 54 kg
- Diagnosis of non-alcoholic steatohepatitis (NASH) as evidenced by imaging or other diagnostic assessments. Subject should have documented liver fat content ≥ 10.0 % as measured by MRI method prior to study agentagent administration.
- Phenotypic diagnosis of NASH based on one or more of the following:
- Alanine aminotransferase (ALT) levels ≥ 1.5x upper limit of normal (ULN) on at least two occasions, seven or more days apart, prior to study agent administration
- ALT ≥ ULN on at least two occasions, seven or more days apart, prior to study agent administration AND body mass index (BMI) ≥ 25 AND diagnosis of Type 2 DM
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- Have adequate organ functions as defined by the following examinations prior to the start of study treatment:
- Hematology: Hemoglobin ≥ 9 g/dL, a platelet count ≥ 100 x 10^9/L, and a white blood cell count ≥ 3.0 x 10^9/L
- Renal: creatinine clearance ≥ 90 mL/min (by Cockcroft-Gault equation), serum uric acid < 9.0 mg/dL
- Able to provide written informed consent, and understand and comply with the requirements of the study
Who cannot join
- Subjects who meet any of the following criteria are not eligible to enter the study:
- Decompensated or severe liver disease as evidenced by one or more of the following:
- Confirmed cirrhosis or suspicion of cirrhosis
- Liver transplant
- Liver malignancy
- Ascites
Show all 18Show fewer
- Bilirubin > ULN, or ALT or AST > 5 x ULN, or Alkaline phosphatase (ALP) > 2x ULN
- Acute or chronic hepatitis A, B, C, HIV, or other liver diseases affecting liver function.
- Patients with cysts, hemangiomas, or similar abnormalities, are accepted.
- History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years
- Subjects who are unable to undergo an MRI scan.
- Subjects have electronically, magnetically and mechanically activated implanted devices, including but not limited to automatic cardioverter defibrillators, cardiac pacemakers, insulin pumps, metallic splinters in the eye, ferromagnetic haemostatic clips in central nervous systems or vascular vessels.
- Significant systemic or major illness other than liver disease, including auto-immune disease, coronary artery disease, cerebrovascular disease, malignant neoplasms, pulmonary disease, renal insufficiency, serious psychiatric disease, and/or other serious disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study
- Documented history of serious allergic reaction to SNP-612 or any structurally related compounds
- Diabetic patients who have not maintained a stable dose of oral medication for hyperglycemia or have had more than 10 percent change in their insulin dose over the past two months
- Regular use of agents that are potent against hepatitis or affecting lipid metabolisms, including but not limited to HMGCoA reductase inhibitors (statins), fibrates, silymarin, N-acetylcysteine, or anti-TNF therapies.
- Pregnant or lactating
- Female of child-bearing potential who are not committed to taking reliable contraception during the participation of the study and at least 4 weeks after the end of the study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Assess the Hepatic Protection Effect of a Food Supplement Product, SNP-612, in Patients With Non-alcoholic Fatty Liver Disease
The primary objective of the study is to compare the changes in ALT to baseline among patients with non-alcoholic fatty liver disease (NAFLD) following the 3-month treatment of 3 different dosing regimens of SNP-612. The secondary objectives will be to compare the changes in other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates.
Read the detailed description
An open-label study will be conducted in medical centers around Taiwan. The objective of the study is to investigate the efficacy and safety of SNP-612 for the treatment of NAFLD.
Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study. Considering a 10% drop-out rate, approximately 72 subjects will be enrolled in order to recruit 64 evaluable subject subjects to complete the enrollment.
Subjects will be administered the study agents oral daily for 3 months or until treatment terminates prematurely. Subjects will return to the study center for clinical evaluation once every 4 weeks throughout the treatment period. Clinical assessment procedures and laboratory tests including ultrasound imaging, hematology with differential, biochemistry, liver function panel, and urinalysis, will be performed at each study visit. The primary endpoint assessment will be the reduction of ALT, at completion of Week 12 compared to baseline. With 64 evaluable patients, there will be an 80% chance of detecting a significant difference at a two sided 0.05 significance level.
Subjects who finish treatment or discontinue prematurely from the study for any reason after receiving one or more doses of study agent will be assessed for safety for 2 (±1) weeks after the last study agent dose or longer in the case of any significant AE or abnormal biochemical or clinical finding.
Each subject will participate in the study for approximately 14 weeks (including the enrollment/baseline visit, 3 routine monthly visits during treatment period, and 1 follow-up visit after 2 weeks of the end of treatment).
It is assumed the study will include a 6 months enrollment period and a further 4 months to complete the follow-up for all enrolled patients.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- SNP-612 dose1, SNP-612 dose2
- 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.
SNP-612 dose1Drug
Subjects will take dose1 once a day orally for 12 weeks
SNP-612 dose2Drug
Subjects will take dose2 once a day orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| SNP-612 dose1 | Experimental | dose1 once a day orally for 12 weeks Receives: Drug: SNP-612 dose1 |
| SNP-612 dose2 | Experimental | dose2 once a day orally for 12 weeks Receives: Drug: SNP-612 dose2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ALT
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Measured: 12 weeks
Secondary outcomes (8)
Change in serum AST
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Measured: 12 weeks
Change in serum Alk-P
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Measured: 12 weeks
Change in serum γ-GT
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Measured: 12 weeks
Change in GSP
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Measured: 12 weeks
Change in liver fat content as measured by liver fat fraction (FF) with magnetic resonance imaging method.
A non-invasive method will be utilized to estimate liver fat content (%) by MRI calculated liver FF.
Measured: 12 weeks
Change in serum CK-18 fragment levels
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Measured: 12 weeks
Rate of AE/SAE
Rate of patients who experience AE/SAE at end of treatment
Measured: 12 weeks
Rate of AEs leading to discontinuation at end of treatment
Rate of patients who experience AEs leading to discontinuation at end of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start4 Aug 2017
- Primary completion22 Sep 2021
- Study completion19 Oct 2021
Why it stopped: recruitment difficulties due to Covid-19
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 NASH - Nonalcoholic SteatohepatitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: SNP-612 dose1 Experimental: SNP-612 dose2
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinew Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu-Lueng Shih, MD,PhD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868566
- Sponsor's protocol ID
- SNP-612-202
- Status last verified
- Jan 2023
- First submitted
- 6 Mar 2019
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ho HT, Shih YL, Huang TY, Fang WH, Liu CH, Lin JC, Hsiang CW, Chu KM, Hsiong CH, Chen GJ, Wu YE, Hao JY, Liang CW, Hu OY. Mixed active metabolites of the SNP-6 series of novel compounds mitigate metabolic dysfunction-associated steatohepatitis and fibrosis: promising results from pre-clinical and clinical trials. J Transl Med. 2024 Oct 14;22(1):936. doi: 10.1186/s12967-024-05686-7.
PubMed 39402603
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Hepatic Protection Effect of a Food Supplement Product, SNP-612, in Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03868566
- Acronym / sponsor ID
- SNP-612-202
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties due to Covid-19
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sinew Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 11 Mar 2019 (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 primary objective of the study is to compare the changes in ALT to baseline among patients with non-alcoholic fatty liver disease (NAFLD) following the 3-month treatment of 3 different dosing regimens of SNP-612. The secondary objectives will be to compare the changes in other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates.
Detailed description
An open-label study will be conducted in medical centers around Taiwan. The objective of the study is to investigate the efficacy and safety of SNP-612 for the treatment of NAFLD.
Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study. Considering a 10% drop-out rate, approximately 72 subjects will be enrolled in order to recruit 64 evaluable subject subjects to complete the enrollment.
Subjects will be administered the study agents oral daily for 3 months or until treatment terminates prematurely. Subjects will return to the study center for clinical evaluation once every 4 weeks throughout the treatment period. Clinical assessment procedures and laboratory tests including ultrasound imaging, hematology with differential, biochemistry, liver function panel, and urinalysis, will be performed at each study visit. The primary endpoint assessment will be the reduction of ALT, at completion of Week 12 compared to baseline. With 64 evaluable patients, there will be an 80% chance of detecting a significant difference at a two sided 0.05 significance level.
Subjects who finish treatment or discontinue prematurely from the study for any reason after receiving one or more doses of study agent will be assessed for safety for 2 (±1) weeks after the last study agent dose or longer in the case of any significant AE or abnormal biochemical or clinical finding.
Each subject will participate in the study for approximately 14 weeks (including the enrollment/baseline visit, 3 routine monthly visits during treatment period, and 1 follow-up visit after 2 weeks of the end of treatment).
It is assumed the study will include a 6 months enrollment period and a further 4 months to complete the follow-up for all enrolled patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: SNP-612 dose1 Experimental: SNP-612 dose2
| Arm | Type | Receives |
|---|---|---|
| SNP-612 dose1 | Experimental | Drug: SNP-612 dose1dose1 once a day orally for 12 weeks |
| SNP-612 dose2 | Experimental | Drug: SNP-612 dose2dose2 once a day orally for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 20 years
- Body weight ≥ 54 kg
- Diagnosis of non-alcoholic steatohepatitis (NASH) as evidenced by imaging or other diagnostic assessments. Subject should have documented liver fat content ≥ 10.0 % as measured by MRI method prior to study agentagent administration.
- Phenotypic diagnosis of NASH based on one or more of the following:
- Have adequate organ functions as defined by the following examinations prior to the start of study treatment:
Key exclusion criteria (18 listed)
- Decompensated or severe liver disease as evidenced by one or more of the following:
- Patients with cysts, hemangiomas, or similar abnormalities, are accepted.
- History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years
- Subjects who are unable to undergo an MRI scan.
- Subjects have electronically, magnetically and mechanically activated implanted devices, including but not limited to automatic cardioverter defibrillators, cardiac pacemakers, insulin pumps, metallic splinters in the eye, ferromagnetic haemostatic clips in central nervous systems or vascular vessels.
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 |
|---|---|---|
| SNP-612 dose1Subjects will take dose1 once a day orally for 12 weeks | Drug | SNP-612 dose1 |
| SNP-612 dose2Subjects will take dose2 once a day orally for 12 weeks | Drug | SNP-612 dose2 |
Primary outcome
Change in serum ALT
Time frame: 12 weeks
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
8 secondary outcomes
Change in serum AST
Time frame: 12 weeks
Change in serum Alk-P
Time frame: 12 weeks
Change in serum γ-GT
Time frame: 12 weeks
Change in GSP
Time frame: 12 weeks
Change in liver fat content as measured by liver fat fraction (FF) with magnetic resonance imaging method.
Time frame: 12 weeks
Change in serum CK-18 fragment levels
Time frame: 12 weeks
Rate of AE/SAE
Time frame: 12 weeks
Rate of AEs leading to discontinuation at end of treatment
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: recruitment difficulties due to Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: PubMed 39402603Ho HT, Shih YL, Huang TY, Fang WH, Liu CH, Lin JC, Hsiang CW, Chu KM, Hsiong CH, Chen GJ, Wu YE, Hao JY, Liang CW, Hu OY. Mixed active metabolites of the SNP-6 series of novel compounds mitigate metabolic dysfunction-associated steatohepatitis and fibrosis: promising results from pre-clinical and clinical trials. J Transl Med. 2024 Oct 14;22(1):936. doi: 10.1186/s12967-024-05686-7.
- Individual participant dataSharing planned: No
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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.
Yu-Lueng Shih, MD,PhD principal investigator
Tri-Service General Hospital (TSGH)
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 SNP-612 dose1 and SNP-612 dose2 in people with NASH - Nonalcoholic Steatohepatitis, run by Sinew Pharma Inc. at 1 site in Taiwan.
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 10 inclusion and 18 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: stopped early, as of the sponsor's last update on 6 Jan 2023. 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 Taiwan. 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. 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 was stopped early (reason given: recruitment difficulties due to Covid-19). Results are not available in the source record.
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?
Change in serum ALT (time frame: 12 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 NCT03868566, 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 6 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.