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Can a single pill tackle both fatty liver and diabetes?

NCT ID NCT05623189

Disease control Sponsor: HighTide Therapeutics (Hong Kong) Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests an experimental oral drug called HTD1801 in adults with nonalcoholic steatohepatitis (NASH), a serious liver condition, along with liver fibrosis and type 2 diabetes or prediabetes. Participants receive either HTD1801 or a placebo to see if the drug can improve liver health, such as reducing liver fat and inflammation without worsening scarring. The study aims to find out whether this treatment could offer a new option for managing both liver and metabolic problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HTD1801, an experimental oral drug taken as capsules
What this could lead to
If successful, this could point toward a new treatment that slows or reverses liver damage in people with NASH and diabetes.
What could go wrong
This is an early-stage trial, so the drug may not work as hoped or could cause side effects. Results need confirmation in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

218 people

The number who actually took part.

Started

Dec 2022

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nonalcoholic steatohepatitis (NASH) Type 2 diabetes

Contacts and locations

Locations

  • Adobe Clinical Research LLC

    Tucson, Arizona, 85712, United States

  • Aizona Liver Health

    Tucson, Arizona, 85712, United States

  • Arizona Liver Health - Glendae

    Peoria, Arizona, 85381, United States

  • California Liver Institute

    Pasadena, California, 91105, United States

  • Catalina Research Institute

    Montclair, California, 91763, United States

  • Chinese University of Hong Kong Prince of Wales Hospital

    Shatin, Hong Kong

  • ClinCloud LLC Maitland

    Maitland, Florida, 32751, United States

  • ClinCloud LLC Melbourn

    Viera, Florida, 32940, United States

  • ClinSearch LLC

    Chattanooga, Tennessee, 37421, United States

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida, 33014, United States

  • Clinical Research Institute of Ohio

    Westlake, Ohio, 44145, United States

  • Clinnova Research Solutions

    Garden Grove, California, 92845, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Covenant Metabolic Specialists - Fort Meyers

    Fort Myers, Florida, 33912, United States

  • Covenant Metabolic Specialists - Sarasota

    Sarasota, Florida, 34240, United States

  • EPIC Medical Research

    DeSoto, Texas, 75154, United States

  • Evolution Clinical Trials, Inc.

    Hialeah Gardens, Florida, 33016, United States

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida, 33434, United States

  • FDI Clinical Research

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

  • Floridain Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Impact Research Institute

    Waco, Texas, 76710, United States

  • Inland Empire Liver Foundation

    Rialto, California, 92377, United States

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada, 89106, United States

  • Liver Institute NW

    Seattle, Washington, 98105, United States

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

    Louisville, Kentucky, 40213, United States

  • Lucas Research - Diabetes and Endocrinology

    Morehead City, North Carolina, 28557, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401, United States

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485, United States

  • Panax Clinical Research

    Miami Lakes, Florida, 33014, United States

  • Pinnacle Clinical Research

    Austin, Texas, 78757, United States

  • Pinnacle Clinical Research San Antonio

    San Antonio, Texas, 78229, United States

  • Pinnacle Research, Georgetown TX

    Georgetown, Texas, 78229, United States

  • Premier Research

    Clarksville, Tennessee, 37043, United States

  • Quality Research, Inc.

    San Antonio, Texas, 78209, United States

  • San Fernando Valley Health Institute

    Canoga Park, California, 91302, United States

  • South Texas Research Institute

    Brownsville, Texas, 78539, United States

  • Sun Research Institute

    San Antonio, Texas, 78215, United States

  • Tampa Bay Medical Research, Inc.

    Clearwater, Florida, 33761, United States

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • Tandem Clinical Research GI - New York

    New York, New York, 10033, United States

  • Texas Clinical Research Institute

    Arlington, Texas, 76012, United States

  • The Institute for Liver Health (Arizona Liver Health)

    Chandler, Arizona, 85224, United States

  • Theia Clinical Research LLC

    Temple Terrace, Florida, 34211, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.