Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HTD1801 · 2 trials · 3 indications
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.
TEAEs are defined as any AEs that commenced on or after exposure to study drug or any pre-existing AE that worsened in either intensity or frequency after exposure to study drug.
| Arm | Type | Description |
|---|---|---|
| HTD1801 | EXPERIMENTAL | HTD1801,1250 mg, BID |
| placebo | PLACEBO_COMPARATOR | placebo, BID |
| HTD1801 250 mg BID | EXPERIMENTAL | Subjects received 500 mg/day HTD1801 |
| HTD1801 500 mg BID | EXPERIMENTAL | Subjects received 1000 mg/day HTD1801 |
| HTD1801 1000 mg BID | EXPERIMENTAL | Subjects received 2000 mg/day HTD1801 |
| Name | Type | Description |
|---|---|---|
| HTD1801 | DRUG | HTD1801,1250 mg, BID |
| Placebo | DRUG | Placebo, BID |
| HTD1801 Tablets, 500 mg | DRUG | 500 mg/day (250 mg BID) |
| HTD1801 Tablets, 1000 mg | DRUG | 1000 mg/day (500 mg BID) |
| HTD1801 Tablets, 2000 mg | DRUG | 2000 mg/day (1000 mg BID) |
| Placebo to match 500 mg HTD1801 | DRUG | 2 tablets/day (1 tablet BID) |
| Placebo to match 1000 mg HTD1801 | DRUG | 4 tablets/day (2 tablet BID) |
| Placebo to match 2000 mg HTD1801 | DRUG | 8 tablets/day (4 tablet BID) |
Key Inclusion criteria: * Clinical diagnosis of non-alcoholic steatohepatitis (NASH) upon central read of a liver biopsy obtained no more than 6 months before Day 0. * Histologic evidence of fibrosis stage 2 or stage 3 as defined by the non-alcoholic steatohepatitis (NASH) clinical research network...
HTD1801 is an investigational small molecule being developed for hypercholesterolemia and nonalcoholic steatohepatitis (NASH). It is studied in adults with these metabolic conditions, including those with NASH and liver fibrosis who also have type 2 diabetes or pre-diabetes.
HTD1801 is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The drug is in clinical development for metabolic conditions including hypercholesterolemia and nonalcoholic steatohepatitis (NASH).
HTD1801 is in clinical development. A Phase 1 trial for hypercholesterolemia has been completed, and a Phase 2 trial for nonalcoholic steatohepatitis (NASH) with type 2 diabetes or pre-diabetes has also been completed. It remains investigational and is not FDA approved.
HTD1801 has two completed trials. NCT03381287 was a Phase 1 multiple ascending dose study in 50 adults with hypercholesterolemia in Australia. NCT05623189 was a Phase 2 study in 218 adults with nonalcoholic steatohepatitis and liver fibrosis who have type 2 diabetes or pre-diabetes, conducted in the United States, Hong Kong, and Puerto Rico.
No alternative names for HTD1801 have been disclosed. It is referred to solely as HTD1801 in clinical trial records and development information.