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

NCT05623189 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: HTD1801.PCT014The CENTRICITY Study
• Study Type: interventional
• Target: 218
• Locations: 3 countries
• Sites: 45

Brief 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.

Conditions

Nonalcoholic Steatohepatitis (NASH); Type 2 Diabetes

Outcome Measures

Primary Outcomes (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.

  Up to 60 Weeks

Secondary Outcomes (28)

• Endpoint 1

  Up to 60 Weeks

• Endpoint 2

  Up to 60 Weeks

• Endpoint 3

  Up to 60 Weeks

• Endpoint 4

  Up to 60 Weeks

• Endpoint 5

  Up to 60 Weeks

Study Arms (2)

HTD1801

EXPERIMENTAL

HTD1801,1250 mg, BID

Drug: HTD1801

placebo

PLACEBO COMPARATOR

placebo, BID

Drug: Placebo

Interventions

HTD1801 DRUG

HTD1801,1250 mg, BID

Also known as: HTD1801 capsules

HTD1801

Placebo DRUG

Placebo, BID

Also known as: placebo capsules

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• HighTide Biopharma Pty Ltd: lead

Study Sites (45)

The Institute for Liver Health (Arizona Liver Health)

Chandler, Arizona, 85224, United States

Location

Arizona Liver Health - Glendae

Peoria, Arizona, 85381, United States

Location

Adobe Clinical Research LLC

Tucson, Arizona, 85712, United States

Location

Aizona Liver Health

Tucson, Arizona, 85712, United States

Location

San Fernando Valley Health Institute

Canoga Park, California, 91302, United States

Location

Clinnova Research Solutions

Garden Grove, California, 92845, United States

Location

Catalina Research Institute

Montclair, California, 91763, United States

Location

California Liver Institute

Pasadena, California, 91105, United States

Location

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Excel Medical Clinical Trials, LLC

Boca Raton, Florida, 33434, United States

Location

Tampa Bay Medical Research, Inc.

Clearwater, Florida, 33761, United States

Location

Covenant Metabolic Specialists - Fort Meyers

Fort Myers, Florida, 33912, United States

Location

Evolution Clinical Trials, Inc.

Hialeah Gardens, Florida, 33016, United States

Location

ClinCloud LLC Maitland

Maitland, Florida, 32751, United States

Location

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Floridain Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Covenant Metabolic Specialists - Sarasota

Sarasota, Florida, 34240, United States

Location

Theia Clinical Research LLC

Temple Terrace, Florida, 34211, United States

Location

ClinCloud LLC Melbourn

Viera, Florida, 32940, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Louisvill Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, 40213, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Jubilee Clinical Research, Inc.

Las Vegas, Nevada, 89106, United States

Location

Tandem Clinical Research GI - New York

New York, New York, 10033, United States

Location

Lucas Research - Diabetes and Endocrinology

Morehead City, North Carolina, 28557, United States

Location

Clinical Research Institute of Ohio

Westlake, Ohio, 44145, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

ClinSearch LLC

Chattanooga, Tennessee, 37421, United States

Location

Premier Research

Clarksville, Tennessee, 37043, United States

Location

Texas Clinical Research Institute

Arlington, Texas, 76012, United States

Location

Pinnacle Clinical Research

Austin, Texas, 78757, United States

Location

South Texas Research Institute

Brownsville, Texas, 78539, United States

Location

EPIC Medical Research

DeSoto, Texas, 75154, United States

Location

Pinnacle Research, Georgetown TX

Georgetown, Texas, 78229, United States

Location

Quality Research, Inc.

San Antonio, Texas, 78209, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research San Antonio

San Antonio, Texas, 78229, United States

Location

Impact Research Institute

Waco, Texas, 76710, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Liver Institute NW

Seattle, Washington, 98105, United States

Location

Chinese University of Hong Kong Prince of Wales Hospital

Shatin, Hong Kong

Location

FDI Clinical Research

San Juan, Munoz Rivera San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Adrian Di Bisceglie, MD, FACP, FAASLD

  Hightide Therapeutics USA, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: November 21, 2022
• Study Start: December 27, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (43); HK (1); PR (1)