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| ID | Type | Description | Link |
|---|---|---|---|
| The CENTRICITY Study | Other Identifier | HighTide Therapeutics |
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A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.
This phase 2b, double-blind, randomized, placebo-controlled, multicenter study will evaluate the effect of HTD1801, 1250 mg twice daily (BID) compared to placebo BID on histologic improvements in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.
The study will enroll approximately 210 subjects with biopsy-confirmed non-alcoholic steatohepatitis and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive investigational product for up to 60 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTD1801 | Experimental | HTD1801,1250 mg, BID |
|
| placebo | Placebo Comparator | placebo, BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTD1801 | Drug | HTD1801,1250 mg, BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | A decrease of ≥2-points in non-alcoholic fatty liver disease activity score (NAS) with ≥1-point decrease of either lobular inflammation or ballooning and no worsening of fibrosis; OR Resolution of non-alcoholic steatohepatitis (NASH) (defined as the overall histopathologic interpretation of 1) "no fatty liver disease" or 2) "fatty liver disease (simple or isolated steatosis) without steatohepatitis AND a non-alcoholic fatty liver disease activity score (NAS) of 0 for ballooning and 0-1 for inflammation and no worsening of fibrosis. Nonalcoholic fatty liver disease activity score (NAS) is a histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2). The higher the score the more severe the disease. The total range for non-alcoholic fatty liver disease activity score (NAS) is between 0 to 8. The lower the score the better the outcome. | Up to 60 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endpoint 1 | Percentage of subjects with resolution of non-alcoholic steatohepatitis (NASH) on overall histopathological reading | Up to 60 Weeks |
| Endpoint 2 | Percentage of subjects with resolution of non-alcoholic steatohepatitis hepatitis (NASH) and at least a 2-point improvement in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) and no worsening of liver fibrosis |
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Key Inclusion criteria:
Key Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Di Bisceglie, MD, FACP, FAASLD | Hightide Therapeutics USA, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Liver Health (Arizona Liver Health) | Chandler | Arizona | 85224 | United States | ||
| Arizona Liver Health - Glendae |
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This phase 2b, double-blind, placebo-controlled, multicenter study will evaluate the effect of HTD1801 on histologic improvements in adult subjects with non-alcoholic steatohepatitis (NASH) and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes. Approximately 210 subjects with biopsy-confirmed NASH and evidence of stage 2 or stage 3 liver fibrosis will be randomized 2:1 to receive HTD1801 1250 mg twice daily (BID) or placebo BID. Subjects will receive investigational product for up to 60 weeks.
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| Placebo | Drug | Placebo, BID |
|
|
| Up to 60 Weeks |
| Endpoint 3 | Percentage of subjects with a ≥1-stage improvement in liver fibrosis. | Up to 60 Weeks |
| Endpoint 4 | Percentage of subjects with a ≥1-stage improvement in liver fibrosis and no worsening of non-alcoholic steatohepatitis (NASH). | Up to 60 Weeks |
| Endpoint 5 | Percentage of subjects with a ≥2-stage improvement in liver fibrosis. | Up to 60 Weeks |
| Endpoint 6 | Percentage of subjects with a ≥2-point improvement in non-alcoholic fatty liver disease activity score (NAS) and no worsening of liver fibrosis. | Up to 60 Weeks |
| Endpoint 7 | Percentage of subjects with an improvement in each of the individual non-alcoholic fatty liver disease activity score (NAS) components (ballooning, inflammation, or steatosis). | Up to 60 Weeks |
| Endpoint 8 | Percentage of subjects with improvement of non-alcoholic steatohepatitis (NASH) based on overall histopathologic interpretation. | Up to 60 Weeks |
| Endpoint 9 | Absolute and percent change in alanine aminotransferase (ALT) from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 10 | Absolute and percent change in aspartate aminotransferase (AST) from baseline to end of treatment. | Up to 60 Weeks. |
| Endpoint 11 | Absolute and percent change in gamma-glutamyl transferase (GGT) from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 12 | Absolute and percent change in total bilirubin from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 13 | Absolute and percent change in direct bilirubin from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 14 | Absolute and percent change in hemoglobin A1c (HbA1c) from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 15 | Absolute and percent change in fasting plasma glucose from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 16 | Absolute and percent change in body weight from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 17 | Absolute and percent change in body mass index (BMI) from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 18 | Absolute and percent change in hip circumference from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 19 | Absolute and percent change in waist circumference from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 20 | Absolute and percent change in total cholesterol from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 21 | Absolute and percent change in low-density lipoprotein cholesterol (LDL-c) from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 22 | Absolute and percent change in lipoprotein A (Lpa) from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 23 | Absolute and percent change in high-density lipoprotein cholesterol (HDL-c) from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 24 | Absolute and percent change in triglycerides from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 25 | Absolute and percent change in apolipoprotein B (ApoB) from baseline to end of treatment. | Up to 60 Weeks |
| Endpoint 26 | Absolute and percent change in liver stiffness as measured by vibration-controlled transient elastography (VCTE) using FibroScan® device from baseline to end of treatment. The VCTE score is measured in Kilopascal Pressure Unit (kPa) and ranges from 2 to 75 kPa. The higher the kPa score the more severe the liver stiffness. | Up to 60 Weeks |
| Endpoint 27 | Absolute and percent change in liver fat content as measured by controlled attenuation parameter (CAP) using FibroScan® device from baseline to end of treatment. The controlled attenuation parameter (CAP) score is measured in decibels per meter (dB/m) it ranges from 100 to 400 dB/m. The higher the controlled attenuation parameter (CAP) score the more severe the steatosis. | Up to 60 Weeks |
| Endpoint 28 | Absolute and percent change in the FibroScan-AST (FAST) score from baseline to end of treatment. Fast score will be calculated based on LSM, CAP and AST values using FAST equation. An equal to or more than 0.35 value thru equal or less than 0.81 value is positive predictive value for nonalcoholic steatohepatitis and a negative predictive value from 0.73 to 1.0. | Up to 60 Weeks |
| Peoria |
| Arizona |
| 85381 |
| United States |
| Adobe Clinical Research LLC | Tucson | Arizona | 85712 | United States |
| Aizona Liver Health | Tucson | Arizona | 85712 | United States |
| San Fernando Valley Health Institute | Canoga Park | California | 91302 | United States |
| Clinnova Research Solutions | Garden Grove | California | 92845 | United States |
| Catalina Research Institute | Montclair | California | 91763 | United States |
| California Liver Institute | Pasadena | California | 91105 | United States |
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States |
| Excel Medical Clinical Trials, LLC | Boca Raton | Florida | 33434 | United States |
| Tampa Bay Medical Research, Inc. | Clearwater | Florida | 33761 | United States |
| Covenant Metabolic Specialists - Fort Meyers | Fort Myers | Florida | 33912 | United States |
| Evolution Clinical Trials, Inc. | Hialeah Gardens | Florida | 33016 | United States |
| ClinCloud LLC Maitland | Maitland | Florida | 32751 | United States |
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014 | United States |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | United States |
| Floridain Clinical Research | Miami Lakes | Florida | 33016 | United States |
| Covenant Metabolic Specialists - Sarasota | Sarasota | Florida | 34240 | United States |
| Theia Clinical Research LLC | Temple Terrace | Florida | 34211 | United States |
| ClinCloud LLC Melbourn | Viera | Florida | 32940 | United States |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Louisvill Metabolic and Atherosclerosis Research Center (L-MARC) | Louisville | Kentucky | 40213 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Jubilee Clinical Research, Inc. | Las Vegas | Nevada | 89106 | United States |
| Tandem Clinical Research GI - New York | New York | New York | 10033 | United States |
| Lucas Research - Diabetes and Endocrinology | Morehead City | North Carolina | 28557 | United States |
| Clinical Research Institute of Ohio | Westlake | Ohio | 44145 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| ClinSearch LLC | Chattanooga | Tennessee | 37421 | United States |
| Premier Research | Clarksville | Tennessee | 37043 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Pinnacle Clinical Research | Austin | Texas | 78757 | United States |
| South Texas Research Institute | Brownsville | Texas | 78539 | United States |
| EPIC Medical Research | DeSoto | Texas | 75154 | United States |
| Pinnacle Research, Georgetown TX | Georgetown | Texas | 78229 | United States |
| Quality Research, Inc. | San Antonio | Texas | 78209 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research San Antonio | San Antonio | Texas | 78229 | United States |
| Impact Research Institute | Waco | Texas | 76710 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| Liver Institute NW | Seattle | Washington | 98105 | United States |
| Chinese University of Hong Kong Prince of Wales Hospital | Shatin | Hong Kong |
| FDI Clinical Research | San Juan | Munoz Rivera San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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