NASH - Nonalcoholic SteatohepatitisPhase 2NCT03468556
A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis
A Phase 2 study testing SNP-610 in people with NASH - Nonalcoholic Steatohepatitis, run by Sinew Pharma Inc..
Trial summary
The primary objective of the study is to compare the changes in serum ALT level among patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg SNP-610 or the placebo. 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-610
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Dec 2027
- Phase
- Phase 2
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 drug administration.
- Alanine aminotransferase (ALT) levels ≥ 2.0x upper limit of normal (ULN) on at least two occasions, seven or more days apart, prior to study drug administration
- 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
- 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
- Bilirubin >2 x ULN, or ALT or AST > 10 x ULN
Show all 18Show fewer
- 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-610 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.
- Note: refer to Section 6.5 Prohibited agents for details.
- Pregnant or lactating
- Female of child-bearing potential who are not committed to take reliable contraception during the participation of the study and at least 4 weeks after the end of the study treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The primary objective of the study is to compare the changes in serum ALT level among patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg SNP-610 or the placebo. The secondary objectives will be to compare the changes in liver fat fraction, other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates among the interventional and placebo arms.
Read the detailed description
A randomized, double-blind, placebo controlled study will be conducted in medical centers around Taiwan.
The objective of the study is to investigate the efficacy and safety of SNP-610 for the treatment of NASH, assuming the treatment efficacy of the investigational product is superior to the placebo control.
Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study. Eligible subjects will be randomized in a 1:1 ratio to receive study drug or placebo control. Considering a 10% drop-out rate, approximately 80 subjects will be enrolled in order to recruit 70 evaluable subjects, each arm will be at least 35 evaluable subjects to complete the enrollment.
Subjects will be administered the test drugs or placebo 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 treatment.
Subjects who finish treatment or discontinue prematurely from the study for any reason after receiving one or more doses of study drug will be assessed for safety for 2 (±1) weeks after the last study drug 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-610, Placebo Oral Tablet
- 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-610Drug
Subjects will take 2 tablets once a day orally for 12 weeks
Placebo Oral TabletDrug
Subjects will take 2 tablets once a day orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| test drug | Experimental | 2 tabs of SNP-610 Receives: Drug: SNP-610 |
| placebo | Placebo comparator | 2 tabs of placebo Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine aminotransferase
Absolute change from baseline in serum alanine aminotransferase (ALT/GPT)
Measured: 12 weeks
Secondary outcomes (8)
MRI liver FF
Absolute change from baseline in liver fat content
Measured: 12 weeks
MRI liver FF
Relative change from baseline in liver fat content
Measured: 12 weeks
Aspartate aminotransferase
Change in serum level at 12 weeks
Measured: 12 weeks
Alkaline phosphatase
Change in serum level at 12 weeks
Measured: 12 weeks
Gamma-glutamyl transpeptidase
Change in serum level at 12 weeks
Measured: 12 weeks
Total bilirubin
Change in serum level at 12 weeks
Measured: 12 weeks
Galactose single point
Change in serum level at 12 weeks
Measured: 12 weeks
CK-18
Change in serum level at 12 weeks
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 posted16 Mar 2018
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- test drug
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinew Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468556
- Sponsor's protocol ID
- SNP-610-201
- Status last verified
- May 2025
- First submitted
- 6 Mar 2018
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided