NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
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
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sinew Pharma Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Insulin resistance | Change in insulin resistance at Week 12 | 12 weeks | |
Other | Triglycerides | Changes in serum at Week 12 | 12 weeks | |
Other | Low density lipoprotein | Changes in serum at Week 12 | 12 weeks | |
Other | Total cholesterol | Changes in serum at Week 12 | 12 weeks | |
Other | High density lipoprotein | Changes in serum at Week 12 | 12 weeks | |
Other | Gene expression biomarkers | Gene expression biomarkers (ACC1, Adfp, AOX, Cat, CCL20, CCR2, Cpt1a, CYP2E1, CYP4A11, CYP7A, Dgat1, Dgat2, FAS, Gapdh, Gpx1, Gpx2, Gpx3, Gpx4, GSS, Hadh, Ho1, HSL, IL-10, IL-1ß, IL-6, iNOS, LCAD, NF-?B1, NF-?B2, Ppara, PPARß/d, PPAR?, SCD-1, Sod1, Sod2, Sod3, SREBP-1c, TGFß, TLR4, TNFa, Ucp2, VLCAD, a-SMA, ß-actin) related to NASH changes in blood at Week 12 | 12 weeks | |
Other | Rate of patients who experience AEs leading to discontinuation at end of treatment | 12 weeks | ||
Other | Rate of patients who experience AE/SAE at end of treatment | 12 weeks | ||
Primary | Alanine aminotransferase | Absolute change from baseline in serum alanine aminotransferase (ALT/GPT) | 12 weeks | |
Secondary | MRI liver FF | Absolute change from baseline in liver fat content | 12 weeks | |
Secondary | MRI liver FF | Relative change from baseline in liver fat content | 12 weeks | |
Secondary | Aspartate aminotransferase | Change in serum level at 12 weeks | 12 weeks | |
Secondary | Alkaline phosphatase | Change in serum level at 12 weeks | 12 weeks | |
Secondary | Gamma-glutamyl transpeptidase | Change in serum level at 12 weeks | 12 weeks | |
Secondary | Total bilirubin | Change in serum level at 12 weeks | 12 weeks | |
Secondary | Galactose single point | Change in serum level at 12 weeks | 12 weeks | |
Secondary | CK-18 | Change in serum level at 12 weeks | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03289897 -
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
|
N/A | |
Active, not recruiting |
NCT05479721 -
LITMUS Imaging Study
|
||
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Recruiting |
NCT04976283 -
Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver
|
Phase 4 | |
Completed |
NCT02784444 -
A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
|
Phase 2 | |
Not yet recruiting |
NCT05499949 -
The Franciscus Obesity NASH Study
|
||
Completed |
NCT04321343 -
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 2 | |
Recruiting |
NCT04371042 -
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
|
||
Not yet recruiting |
NCT03648554 -
Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)
|
Phase 4 | |
Completed |
NCT04972396 -
ALT-801 DDI Study in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03748628 -
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
|
Phase 1 | |
Enrolling by invitation |
NCT05195944 -
Semaglutide vs Sitagliptin
|
Phase 4 | |
Completed |
NCT04643795 -
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
|
Phase 1 | |
Terminated |
NCT03669133 -
Vitamin E for NASH Treatment in HIV Infected Individuals
|
Phase 2 | |
Completed |
NCT04066400 -
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
|
N/A | |
Completed |
NCT03536650 -
Effect of DMR in the Treatment of NASH
|
N/A | |
Completed |
NCT03783897 -
A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects
|
Phase 1 | |
Completed |
NCT04618744 -
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 2 | |
Active, not recruiting |
NCT05338034 -
Phase 2a Study of HPG1860 in Subjects With NASH
|
Phase 2 | |
Active, not recruiting |
NCT04653103 -
NASH in Subjects With Different Classes of Obesity
|