A Phase 2 interventional study of HTD1801 and Placebo in Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes, sponsored by HighTide Therapeutics (Hong Kong) Limited. Completed at 45 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by HighTide Therapeutics (Hong Kong) Limited · Phase 2, Interventional, and Treatment
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.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's enrollment of 218 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →HighTide Therapeutics (Hong Kong) Limited is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion criteria:
Key Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HTD1801,1250 mg, BID
Drug: HTD1801
placebo, BID
Drug: Placebo
HTD1801,1250 mg, BID
Also known as: HTD1801 capsules
Placebo, BID
Also known as: placebo capsules
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.
Time frame: Up to 60 Weeks
Endpoint 1
Percentage of subjects with resolution of non-alcoholic steatohepatitis (NASH) on overall histopathological reading
Time frame: 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
Time frame: Up to 60 Weeks
Endpoint 3
Percentage of subjects with a ≥1-stage improvement in liver fibrosis.
Time frame: 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).
Time frame: Up to 60 Weeks
Endpoint 5
Percentage of subjects with a ≥2-stage improvement in liver fibrosis.
Time frame: 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.
Time frame: 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).
Time frame: Up to 60 Weeks
Endpoint 8
Percentage of subjects with improvement of non-alcoholic steatohepatitis (NASH) based on overall histopathologic interpretation.
Time frame: Up to 60 Weeks
Endpoint 9
Absolute and percent change in alanine aminotransferase (ALT) from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 10
Absolute and percent change in aspartate aminotransferase (AST) from baseline to end of treatment.
Time frame: Up to 60 Weeks.
Endpoint 11
Absolute and percent change in gamma-glutamyl transferase (GGT) from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 12
Absolute and percent change in total bilirubin from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 13
Absolute and percent change in direct bilirubin from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 14
Absolute and percent change in hemoglobin A1c (HbA1c) from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 15
Absolute and percent change in fasting plasma glucose from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 16
Absolute and percent change in body weight from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 17
Absolute and percent change in body mass index (BMI) from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 18
Absolute and percent change in hip circumference from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 19
Absolute and percent change in waist circumference from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 20
Absolute and percent change in total cholesterol from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 21
Absolute and percent change in low-density lipoprotein cholesterol (LDL-c) from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 22
Absolute and percent change in lipoprotein A (Lpa) from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 23
Absolute and percent change in high-density lipoprotein cholesterol (HDL-c) from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 24
Absolute and percent change in triglycerides from baseline to end of treatment.
Time frame: Up to 60 Weeks
Endpoint 25
Absolute and percent change in apolipoprotein B (ApoB) from baseline to end of treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 60 Weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Mar 2025, 27 months.
Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 27 months is above that.
Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease →
HighTide Therapeutics (Hong Kong) Limited