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New hope for rare liver disease: experimental drug GS-4321 enters human trials

NCT ID NCT07096193

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests a new drug called GS-4321 for chronic hepatitis delta, a serious liver infection. First, healthy volunteers will help determine safe dosing. Then, people with the disease will receive multiple doses to see if the drug can reduce virus levels and improve liver health. The trial involves about 200 participants and is currently recruiting.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jan 2030

An estimate. End dates often move.

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 69 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Part A: * Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission. Part B: * Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history. * Must be receiving a commercially available entecavir, TAF, or TDF for the treatment of hepatitis B virus (HBV) infection at or prior to enrollment. Coformulation as part of a fixed-dose combination for the treatment of HIV is permitted. * Non-cirrhotic or compensated cirrhosis. * Hepatitis delta virus ribonucleic acid (HDV RNA ) \> 500 IU/mL at screening. * Alanine aminotransferase (ALT) level \> 1 × Upper limit of normal (ULN), but \< 10 × ULN at screening. Key Exclusion Criteria: Part A: * Positive serum or urine pregnancy test. * Participants with plans to breastfeed during the study period. Part B: * Positive serum or urine pregnancy test. * Participants with plans to breastfeed during the study period. * Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV. * Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

hepatitis D virus infection Hepatitis D, Chronic

As listed by the trial registrant

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

Chronic hepatitis delta

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ankara Bilkent City Hospital Oncology Hospital Universiteler Neighborhood

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Ankara Bilkent City Hospital Universiteler Neighborhood, 1604th Street No: 9,

    RECRUITING

    Ankara, 6800, Turkey (Türkiye)

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • Dicle University Faculty of Medicine

    RECRUITING

    Diyarbakrir, 21280, Turkey (Türkiye)

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

    RECRUITING

    Chiayi City, Taiwan

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia

    RECRUITING

    Milan, 882, Italy

  • Fundatia Dr. Victor Babes

    RECRUITING

    Bucharest, 030303, Romania

  • Gastromedica S.R.L.

    RECRUITING

    Iași, 700506, Romania

  • Hacettepe University Faculty of Medicine Hospital Hacettepe Neighborhood

    RECRUITING

    Ankara, 06430, Turkey (Türkiye)

  • IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"

    RECRUITING

    Chinsinau, 2004, Moldova

  • Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals

    RECRUITING

    Bucharest, 21105, Romania

  • Institutul National De Boli Infectioase Prof. Dr. Matei Bals

    RECRUITING

    Bucharest, 021105, Romania

  • Investigative Site

    RECRUITING

    Anaheim, California, 92801, United States

  • Istabul University-Cerrahpasa Faculty of Medicine Hospital

    RECRUITING

    Istanbul, 34000, Turkey (Türkiye)

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Koc University Medical Faculty Hospital

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Korea University Ansan Hospital

    RECRUITING

    Ansan-si, 425-707, South Korea

  • Medizinische Hochschule Hannover, Address: Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie

    RECRUITING

    Hanover, 30625, Germany

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • PMSI Clinical Republican Hospital "Timofei Mosneaga"

    RECRUITING

    Chisinau, MD-2025, Moldova

  • Samsung Medical Center

    RECRUITING

    Seoul, 135-710, South Korea

  • The Catholic University of Korea Bucheon St. Mary's Hospital

    RECRUITING

    Bucheon-si, 14647, South Korea

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    RECRUITING

    Seoul, 06591, South Korea

  • The New York-Presbyterian Hospital

    RECRUITING

    New York, New York, 10021, United States

  • University Multi-profile Hospital for Active Treatment "SofiaMed" 00D

    RECRUITING

    Sofia, 1797, Bulgaria

  • University of California, San Diego - Altman Clinical and Translational Research Institute

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Louisville, Clinical Trials Unit

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Maryland, Institute of Human Virology, Clinical Research Unit

    RECRUITING

    Baltimore, Maryland, 21201, United States