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New drug HPG1860 shows promise in reducing liver fat in NASH patients

NCT ID NCT05338034

Disease control Sponsor: Hepagene (Shanghai) Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested three different doses of HPG1860, an experimental oral drug, against a placebo in 89 adults with nonalcoholic steatohepatitis (NASH), a type of fatty liver disease. The main goals were to check safety and see if the drug could lower liver fat content measured by MRI. Results will help determine if larger studies are warranted.

What this could mean

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

Active substance
HPG1860
What this could lead to
If successful, this could point toward a treatment that reduces liver fat in people with NASH, potentially slowing disease progression.
What could go wrong
This is an early Phase 2a trial with only 89 participants. The main focus is safety, and it may not show enough benefit to move forward. Side effects are possible.

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

89 people

The number who actually took part.

Started

Nov 2021

Finished

Mar 2023

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: 1. Provision of written informed consent prior to any study-specific procedure. 2. Males and females between 18 and 75 years of age 3. Nonpregnant, nonlactating women. 4. Male subjects must agree to utilize a highly effective method of contraception. 5. Body mass index (BMI) of ≥25 kg/m2 at Screening. 6. Non-cirrhotic NASH subjects. 7. NASH subjects with hepatic fat assessed by a central reader 8. Willing and able to adhere to study restrictions and agree to comply with study protocol. Exclusion Criteria: 1. Pregnant or lactating females 2. Current significant alcohol consumption 3. Elevated LDL-C with stable dose of statin an or PCSK9 inhibitor 4. Renal dysfunction or nephritic syndrome or a history of nephritis 5. Recent infarction, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia 6. Uncontrolled hypertension 7. Type 1 diabetes or uncontrolled T2DM 8. Uncontrolled hypothyroidism 9. Liver transplant and/or other significant liver disease or dysfunction 10. HIV antibody positive 11. Known hypersensitivity or formulation excipient 12. Gastrointestinal conditions or procedures that may affect drug absorption 13. Hematologic or coagulation disorders 14. Unstable weight within the last 3 months 15. Active malignancy 16. Unexplained creatine kinase (CK) \>3 × ULN 17. Blood donation, blood transfusion 18. Unable to undergo or contraindication to MRI procedure 19. A medical or situational finding that in the investigator's opinion may compromise the subject's safety or ability to complete the study.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

NASH - nonalcoholic steatohepatitis

Contacts and locations

Locations

  • South Texas Research Institute (STRI)

    Texas City, Texas, 78240, United States

More trials for these conditions

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