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NCT Number: NCT05623189

HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes

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.

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Key information

Conditions

Nonalcoholic Steatohepatitis (NASH) Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chinese University of Hong Kong Prince of Wales Hospital, Shatin, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (CRN) scoring of fibrosis.
  • Clinically documented diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening or prediabetes at screening.
  • BMI >25 kilograms/meters squared (>23 kilograms/meters squared if Asian).

Key Exclusion criteria:

  • Fibrosis stage 4.
  • History of alcohol or substance abuse or dependence.
  • Liver disease unrelated to non-alcoholic steatohepatitis.
  • History of significant cardiovascular disease.
  • History of type 1 diabetes.
  • Inability or unwillingness to undergo 2 planned liver biopsies OR 1 planned biopsy if historical liver biopsy was used to confirm eligibility at entry.

Treatment and study plan

HTD1801

Drug

HTD1801,1250 mg, BID

Other names: HTD1801 capsules

Placebo

Drug

Placebo, BID

Other names: placebo capsules

Primary outcomes

  1. Primary Endpoint

    Time frame: Up to 60 Weeks

    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.

Secondary outcomes

  1. Endpoint 1

    Time frame: Up to 60 Weeks

    Percentage of subjects with resolution of non-alcoholic steatohepatitis (NASH) on overall histopathological reading

  2. Endpoint 2

    Time frame: Up to 60 Weeks

    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

  3. Endpoint 3

    Time frame: Up to 60 Weeks

    Percentage of subjects with a ≥1-stage improvement in liver fibrosis.

  4. Endpoint 4

    Time frame: Up to 60 Weeks

    Percentage of subjects with a ≥1-stage improvement in liver fibrosis and no worsening of non-alcoholic steatohepatitis (NASH).

  5. Endpoint 5

    Time frame: Up to 60 Weeks

    Percentage of subjects with a ≥2-stage improvement in liver fibrosis.

  6. Endpoint 6

    Time frame: Up to 60 Weeks

    Percentage of subjects with a ≥2-point improvement in non-alcoholic fatty liver disease activity score (NAS) and no worsening of liver fibrosis.

  7. Endpoint 7

    Time frame: Up to 60 Weeks

    Percentage of subjects with an improvement in each of the individual non-alcoholic fatty liver disease activity score (NAS) components (ballooning, inflammation, or steatosis).

  8. Endpoint 8

    Time frame: Up to 60 Weeks

    Percentage of subjects with improvement of non-alcoholic steatohepatitis (NASH) based on overall histopathologic interpretation.

  9. Endpoint 9

    Time frame: Up to 60 Weeks

    Absolute and percent change in alanine aminotransferase (ALT) from baseline to end of treatment.

  10. Endpoint 10

    Time frame: Up to 60 Weeks.

    Absolute and percent change in aspartate aminotransferase (AST) from baseline to end of treatment.

  11. Endpoint 11

    Time frame: Up to 60 Weeks

    Absolute and percent change in gamma-glutamyl transferase (GGT) from baseline to end of treatment.

  12. Endpoint 12

    Time frame: Up to 60 Weeks

    Absolute and percent change in total bilirubin from baseline to end of treatment.

  13. Endpoint 13

    Time frame: Up to 60 Weeks

    Absolute and percent change in direct bilirubin from baseline to end of treatment.

  14. Endpoint 14

    Time frame: Up to 60 Weeks

    Absolute and percent change in hemoglobin A1c (HbA1c) from baseline to end of treatment.

  15. Endpoint 15

    Time frame: Up to 60 Weeks

    Absolute and percent change in fasting plasma glucose from baseline to end of treatment.

  16. Endpoint 16

    Time frame: Up to 60 Weeks

    Absolute and percent change in body weight from baseline to end of treatment.

  17. Endpoint 17

    Time frame: Up to 60 Weeks

    Absolute and percent change in body mass index (BMI) from baseline to end of treatment.

  18. Endpoint 18

    Time frame: Up to 60 Weeks

    Absolute and percent change in hip circumference from baseline to end of treatment.

  19. Endpoint 19

    Time frame: Up to 60 Weeks

    Absolute and percent change in waist circumference from baseline to end of treatment.

  20. Endpoint 20

    Time frame: Up to 60 Weeks

    Absolute and percent change in total cholesterol from baseline to end of treatment.

  21. Endpoint 21

    Time frame: Up to 60 Weeks

    Absolute and percent change in low-density lipoprotein cholesterol (LDL-c) from baseline to end of treatment.

  22. Endpoint 22

    Time frame: Up to 60 Weeks

    Absolute and percent change in lipoprotein A (Lpa) from baseline to end of treatment.

  23. Endpoint 23

    Time frame: Up to 60 Weeks

    Absolute and percent change in high-density lipoprotein cholesterol (HDL-c) from baseline to end of treatment.

  24. Endpoint 24

    Time frame: Up to 60 Weeks

    Absolute and percent change in triglycerides from baseline to end of treatment.

  25. Endpoint 25

    Time frame: Up to 60 Weeks

    Absolute and percent change in apolipoprotein B (ApoB) from baseline to end of treatment.

  26. Endpoint 26

    Time frame: Up to 60 Weeks

    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.

  27. Endpoint 27

    Time frame: Up to 60 Weeks

    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.

  28. Endpoint 28

    Time frame: Up to 60 Weeks

    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.

Sponsors and collaborators

Lead sponsor

HighTide Biopharma Pty Ltd

Industry

Registry information

Official study title

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of HTD1801 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis Who Have Type 2 Diabetes (T2DM) or Pre-Diabetes

Acronym: CENTRICITY

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2022
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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