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Nonalcoholic Steatohepatitis (NASH)Phase 2CENTRICITYNCT05623189

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

A Phase 2 study testing HTD1801 in people with Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes, run by HighTide Therapeutics (Hong Kong) Limited at 45 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HTD1801
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
218 participants
Where
45 sitesin 3 countries
Study dates
27 Dec 2022to 31 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

45 sites in 3 countries.

45 sites in 3 countries

United States43 sites

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Pinnacle Clinical Research

    Austin, Texas, 78757

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida, 33434

  • South Texas Research Institute

    Brownsville, Texas, 78539

  • San Fernando Valley Health Institute

    Canoga Park, California, 91302

  • The Institute for Liver Health (Arizona Liver Health)

    Chandler, Arizona, 85224

  • ClinSearch LLC

    Chattanooga, Tennessee, 37421

  • Premier Research

    Clarksville, Tennessee, 37043

  • Tampa Bay Medical Research, Inc.

    Clearwater, Florida, 33761

  • EPIC Medical Research

    DeSoto, Texas, 75154

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Covenant Metabolic Specialists - Fort Meyers

    Fort Myers, Florida, 33912

  • Clinnova Research Solutions

    Garden Grove, California, 92845

  • Pinnacle Research, Georgetown TX

    Georgetown, Texas, 78229

  • Evolution Clinical Trials, Inc.

    Hialeah Gardens, Florida, 33016

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada, 89106

  • Louisvill Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky, 40213

  • ClinCloud LLC Maitland

    Maitland, Florida, 32751

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida, 33014

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Floridain Clinical Research

    Miami Lakes, Florida, 33016

  • Catalina Research Institute

    Montclair, California, 91763

  • Lucas Research - Diabetes and Endocrinology

    Morehead City, North Carolina, 28557

  • Tandem Clinical Research GI - New York

    New York, New York, 10033

  • California Liver Institute

    Pasadena, California, 91105

  • Arizona Liver Health - Glendae

    Peoria, Arizona, 85381

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • Quality Research, Inc.

    San Antonio, Texas, 78209

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research San Antonio

    San Antonio, Texas, 78229

  • Covenant Metabolic Specialists - Sarasota

    Sarasota, Florida, 34240

  • Liver Institute NW

    Seattle, Washington, 98105

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Theia Clinical Research LLC

    Temple Terrace, Florida, 34211

  • Adobe Clinical Research LLC

    Tucson, Arizona, 85712

  • Aizona Liver Health

    Tucson, Arizona, 85712

  • ClinCloud LLC Melbourn

    Viera, Florida, 32940

  • Impact Research Institute

    Waco, Texas, 76710

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • Clinical Research Institute of Ohio

    Westlake, Ohio, 44145

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Hong Kong1 site

  • Chinese University of Hong Kong Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

Puerto Rico1 site

  • FDI Clinical Research

    San Juan, Munoz Rivera San Juan, 00927

Other trials in Puerto Rico

About this study

Official 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

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.

Read the detailed description

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.

Being tested
HTD1801, Placebo
Medical subject headings
Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HTD1801Drug

    Also called HTD1801 capsules

    HTD1801,1250 mg, BID

  • PlaceboDrug

    Also called placebo capsules

    Placebo, BID

Study groups in NCT05623189
Study groupRoleWhat they receive
HTD1801ExperimentalHTD1801,1250 mg, BID
Receives: Drug: HTD1801
placeboPlacebo comparatorplacebo, BID
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 60 Weeks

Secondary outcomes (28)

  1. Endpoint 1

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

    Measured: Up to 60 Weeks

  2. 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

    Measured: Up to 60 Weeks

  3. Endpoint 3

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

    Measured: Up to 60 Weeks

  4. Endpoint 4

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

    Measured: Up to 60 Weeks

  5. Endpoint 5

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

    Measured: Up to 60 Weeks

  6. 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.

    Measured: Up to 60 Weeks

  7. 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).

    Measured: Up to 60 Weeks

  8. Endpoint 8

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

    Measured: Up to 60 Weeks

  9. Endpoint 9

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

    Measured: Up to 60 Weeks

  10. Endpoint 10

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

    Measured: Up to 60 Weeks.

  11. Endpoint 11

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

    Measured: Up to 60 Weeks

  12. Endpoint 12

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

    Measured: Up to 60 Weeks

  13. Endpoint 13

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

    Measured: Up to 60 Weeks

  14. Endpoint 14

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

    Measured: Up to 60 Weeks

  15. Endpoint 15

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

    Measured: Up to 60 Weeks

  16. Endpoint 16

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

    Measured: Up to 60 Weeks

  17. Endpoint 17

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

    Measured: Up to 60 Weeks

  18. Endpoint 18

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

    Measured: Up to 60 Weeks

  19. Endpoint 19

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

    Measured: Up to 60 Weeks

  20. Endpoint 20

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

    Measured: Up to 60 Weeks

  21. Endpoint 21

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

    Measured: Up to 60 Weeks

  22. Endpoint 22

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

    Measured: Up to 60 Weeks

  23. Endpoint 23

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

    Measured: Up to 60 Weeks

  24. Endpoint 24

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

    Measured: Up to 60 Weeks

  25. Endpoint 25

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

    Measured: Up to 60 Weeks

  26. 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.

    Measured: Up to 60 Weeks

  27. 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.

    Measured: Up to 60 Weeks

  28. 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.

    Measured: Up to 60 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start27 Dec 2022
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05623189
Sponsor's protocol ID
HTD1801.PCT014
Other IDs
The CENTRICITY Study
Acronym
CENTRICITY
Status last verified
Aug 2026
First submitted
11 Oct 2022
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HTD1801 in people with Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes, run by HighTide Therapeutics (Hong Kong) Limited at 45 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Hong Kong, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (time frame: Up to 60 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05623189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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