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NCT05623189CompletedPhase 2

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 Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis Who Have Type 2 Diabetes (T2DM) or Pre-Diabetes

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
218 (actual)
First submitted
11 Oct 2022
Start date
27 Dec 2022
Primary completion date
31 Mar 2025
Lead sponsor
HighTide Therapeutics (Hong Kong) Limited
NCT number
NCT05623189

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 218
  • From 27 Dec 2022 to the primary completion date, 31 Mar 2025
  • 45 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Fibrosis stage 4.
  • Inability or unwillingness to undergo 2 planned liver biopsies OR 1 planned biopsy if historical liver biopsy was used to confirm eligibility at entry.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (45)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese University of Hong Kong - Prince of Wales Hospital
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ShatinHong Kong SAR ChinaUnknown status
FDI Clinical Research
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San JuanPuerto RicoUnknown status
Texas Clinical Research Institute
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ArlingtonUnited StatesUnknown status
Pinnacle Clinical Research
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AustinUnited StatesUnknown status
Excel Medical Clinical Trials, LLC
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Boca RatonUnited StatesUnknown status
South Texas Research Institute
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BrownsvilleUnited StatesUnknown status
San Fernando Valley Health Institute
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Canoga ParkUnited StatesUnknown status
The Institute for Liver Health (Arizona Liver Health)
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ChandlerUnited StatesUnknown status
ClinSearch LLC
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ChattanoogaUnited StatesUnknown status
Premier Research
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ClarksvilleUnited StatesUnknown status
Tampa Bay Medical Research, Inc.
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ClearwaterUnited StatesUnknown status
Epic Medical Research
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DeSotoUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Covenant Metabolic Specialists - Fort Meyers
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Fort MyersUnited StatesUnknown status
Clinnova Research Solutions
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Garden GroveUnited StatesUnknown status
Pinnacle Research, Georgetown TX
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GeorgetownUnited StatesUnknown status
Evolution Clinical Trials, Inc.
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Hialeah GardensUnited StatesUnknown status
Jubilee Clinical Research, Inc.
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Las VegasUnited StatesUnknown status
Louisvill Metabolic and Atherosclerosis Research Center (L-MARC)
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LouisvilleUnited StatesUnknown status
ClinCloud LLC Maitland
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MaitlandUnited StatesUnknown status
Manassas Clinical Research Center
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ManassasUnited StatesUnknown status
Tandem Clinical Research
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MarreroUnited StatesUnknown status
Clinical Pharmacology of Miami, LLC
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MiamiUnited StatesUnknown status
Panax Clinical Research
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Miami LakesUnited StatesUnknown status
Floridain Clinical Research
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Miami LakesUnited StatesUnknown status
Catalina Research Institute
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MontclairUnited StatesUnknown status
Lucas Research - Diabetes and Endocrinology
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Morehead CityUnited StatesUnknown status
Tandem Clinical Research GI - New York
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New YorkUnited StatesUnknown status
California Liver Institute
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PasadenaUnited StatesUnknown status
Arizona Liver Health - Glendae
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PeoriaUnited StatesUnknown status
Inland Empire Liver Foundation
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RialtoUnited StatesUnknown status
Sun Research Institute
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San AntonioUnited StatesUnknown status
Quality Research Inc
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San AntonioUnited StatesUnknown status
Pinnacle Clinical Research - San Antonio
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San AntonioUnited StatesUnknown status
Covenant Metabolic Specialists - Sarasota
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SarasotaUnited StatesUnknown status
Liver Institute NW
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SeattleUnited StatesUnknown status
Palmetto Clinical Research
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SummervilleUnited StatesUnknown status
Theia Clinical Research LLC
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Temple TerraceUnited StatesUnknown status
Adobe Clinical Research LLC
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TucsonUnited StatesUnknown status
Aizona Liver Health
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TucsonUnited StatesUnknown status
ClinCloud, LLC Melbourn
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VieraUnited StatesUnknown status
Impact Research Institute
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WacoUnited StatesUnknown status
Clinical Research Institute of Ohio
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WestlakeUnited StatesUnknown status
Metabolic Research Institute, Inc
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West Palm BeachUnited StatesUnknown status
Conquest Research
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Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.