Can a single pill tackle both fatty liver and diabetes?

NCT ID NCT03656744

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether an experimental drug called HTD1801 can reduce liver fat and improve blood sugar control in adults who have both nonalcoholic steatohepatitis (NASH) and type 2 diabetes. Participants receive either HTD1801 or a placebo for 18 weeks, and researchers measure changes in liver fat using MRI scans, along with fasting glucose and HbA1c levels. The study aims to see if this drug could offer a dual benefit for these two linked conditions.

What this could mean

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

Active substance
HTD1801 tablets
What this could lead to
If successful, this could point toward a new treatment that reduces liver fat and improves blood sugar control in people with NASH and type 2 diabetes.
What could go wrong
This is an early-stage proof-of-concept trial with a small number of participants, so results may not hold up in larger studies. The drug may also have side effects not yet fully known.

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

101 people

The number who actually took part.

Started

Nov 2018

Finished

Mar 2020

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.

Inclusion Criteria: * Clinical diagnosis of NASH as assessed by MRI * Clinically documented diagnosis of T2DM * Body mass index (BMI) \>25 kg/m2 Exclusion Criteria: * Liver disease unrelated to NASH * Poorly controlled T2DM or Type 1 Diabetes Mellitus * History of alcohol or substance abuse or dependence * Inability to undergo MRI for any reason * History of significant cardiovascular disease

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Adobe Clinical Research

    Tucson, Arizona, 85712, United States

  • Compass Research

    Orlando, Florida, 32806, United States

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304, United States

  • Digestive Health Research

    Hermitage, Tennessee, 37076, United States

  • Doctors Hospital at Renaissance

    Edinburg, Texas, 78539, United States

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434, United States

  • Florida Research Institute

    Lakewood Rch, Florida, 34211, United States

  • Gastro One

    Germantown, Tennessee, 38138, United States

  • Harborview Medical Center

    Seattle, Washington, 98195, United States

  • Institute for Liver Health

    Chandler, Arizona, 85224, United States

  • Institute for Liver Health

    Tucson, Arizona, 85711, United States

  • Kansas City Research Institute

    Kansas City, Missouri, 64131, United States

  • National Research Institute

    Panorama City, California, 91402, United States

  • Pinnacle Clinical Research

    Austin, Texas, 78746, United States

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229, United States

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

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