Clinical trial NCT05623189: HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis (NASH)
Type 2 Diabetes
Lead sponsor: HighTide Biopharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2022-11-21
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Endpoint
timeFrame: Up to 60 Weeks
Secondary outcomes:
measure: Endpoint 1
timeFrame: Up to 60 Weeks
measure: Endpoint 2
timeFrame: Up to 60 Weeks
measure: Endpoint 3
timeFrame: Up to 60 Weeks
measure: Endpoint 4
timeFrame: Up to 60 Weeks
measure: Endpoint 5
timeFrame: Up to 60 Weeks
measure: Endpoint 6
timeFrame: Up to 60 Weeks
measure: Endpoint 7
timeFrame: Up to 60 Weeks
measure: Endpoint 8
timeFrame: Up to 60 Weeks
measure: Endpoint 9
timeFrame: Up to 60 Weeks
measure: Endpoint 10
timeFrame: Up to 60 Weeks.
measure: Endpoint 11
timeFrame: Up to 60 Weeks
measure: Endpoint 12
timeFrame: Up to 60 Weeks
measure: Endpoint 13
timeFrame: Up to 60 Weeks
measure: Endpoint 14
timeFrame: Up to 60 Weeks
measure: Endpoint 15
timeFrame: Up to 60 Weeks
measure: Endpoint 16
timeFrame: Up to 60 Weeks
measure: Endpoint 17
timeFrame: Up to 60 Weeks
measure: Endpoint 18
timeFrame: Up to 60 Weeks
measure: Endpoint 19
timeFrame: Up to 60 Weeks
measure: Endpoint 20
timeFrame: Up to 60 Weeks
measure: Endpoint 21
timeFrame: Up to 60 Weeks
measure: Endpoint 22
timeFrame: Up to 60 Weeks
measure: Endpoint 23
timeFrame: Up to 60 Weeks
measure: Endpoint 24
timeFrame: Up to 60 Weeks
measure: Endpoint 25
timeFrame: Up to 60 Weeks
measure: Endpoint 26
timeFrame: Up to 60 Weeks
measure: Endpoint 27
timeFrame: Up to 60 Weeks
measure: Endpoint 28
timeFrame: Up to 60 Weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health (Arizona Liver Health)
state: Arizona
city: Peoria
country: United States
facility: Arizona Liver Health - Glendae
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research LLC
state: Arizona
city: Tucson
country: United States
facility: Aizona Liver Health
state: Arizona
city: Canoga Park
country: United States
facility: San Fernando Valley Health Institute
state: California
city: Garden Grove
country: United States
facility: Clinnova Research Solutions
state: California
city: Montclair
country: United States
facility: Catalina Research Institute
state: California
city: Pasadena
country: United States
facility: California Liver Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials, LLC
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Fort Myers
country: United States
facility: Covenant Metabolic Specialists - Fort Meyers
state: Florida
city: Hialeah Gardens
country: United States
facility: Evolution Clinical Trials, Inc.
state: Florida
city: Maitland
country: United States
facility: ClinCloud LLC Maitland
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Floridain Clinical Research
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Sarasota
country: United States
facility: Covenant Metabolic Specialists - Sarasota
state: Florida
city: Temple Terrace
country: United States
facility: Theia Clinical Research LLC
state: Florida
city: Viera
country: United States
facility: ClinCloud LLC Melbourn
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Louisville
country: United States
facility: Louisvill Metabolic and Atherosclerosis Research Center (L-MARC)
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc.
state: Nevada
city: New York
country: United States
facility: Tandem Clinical Research GI - New York
state: New York
city: Morehead City
country: United States
facility: Lucas Research - Diabetes and Endocrinology
state: North Carolina
city: Westlake
country: United States
facility: Clinical Research Institute of Ohio
state: Ohio
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch LLC
state: Tennessee
city: Clarksville
country: United States
facility: Premier Research
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Brownsville
country: United States
facility: South Texas Research Institute
state: Texas
city: DeSoto
country: United States
facility: EPIC Medical Research
state: Texas
city: Georgetown
country: United States
facility: Pinnacle Research, Georgetown TX
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research San Antonio
state: Texas
city: Waco
country: United States
facility: Impact Research Institute
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Seattle
country: United States
facility: Liver Institute NW
state: Washington
city: Shatin
country: Hong Kong
facility: Chinese University of Hong Kong Prince of Wales Hospital
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
Study officials:
affiliation: Hightide Therapeutics USA, LLC
name: Adrian Di Bisceglie, MD, FACP, FAASLD
role: STUDY_DIRECTOR
References: