New drug aims to tame fatty liver disease in 3 months
NCT ID NCT03468556
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called SNP-610 for people with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. About 80 adults will receive either the drug or a placebo for 3 months. The main goal is to see if SNP-610 lowers liver enzyme levels and reduces liver fat.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 20 years 2. Body weight ≥ 54 kg 3. 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. 4. 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 5. Have adequate organ functions as defined by the following examinations prior to the start of study treatment: 1. 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 2. Renal: creatinine clearance ≥ 90 mL/min (by Cockcroft-Gault equation), serum uric acid \< 9.0 mg/dL 6. Able to provide written informed consent, and understand and comply with the requirements of the study Exclusion Criteria: 1. Decompensated or severe liver disease as evidenced by one or more of the following: 1. Confirmed cirrhosis or suspicion of cirrhosis 2. Liver transplant 3. Liver malignancy 4. Ascites 5. Bilirubin \>2 x ULN, or ALT or AST \> 10 x ULN 6. Acute or chronic hepatitis A, B, C, HIV, or other liver diseases affecting liver function. Patients with cysts, hemangiomas, or similar abnormalities, are accepted. 2. 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 3. Subjects who are unable to undergo an MRI scan. 4. 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. 5. 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 6. Documented history of serious allergic reaction to SNP-610 or any structurally related compounds 7. 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 8. 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. 9. Pregnant or lactating 10. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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