Can a single pill tackle both fatty liver and diabetes?
NCT ID NCT03656744
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Digestive system diseases are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new injection help tackle obesity? a trial puts MWN105 to the test
- Can when you eat change how a diabetes drug works?
- Can a new daily pill outperform semaglutide for diabetes?
- Can a new injection tackle obesity, diabetes, and liver disease?
- A smartphone app may help curb the silent march of fatty liver disease toward cirrhosis
- AI and blood biomarkers could catch hidden liver damage