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Can a daily pill tame hepatitis d?

NCT ID NCT07762027

Disease control Sponsor: Assembly Biosciences 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This Phase 2 trial is testing an experimental oral drug called ABI-6250 in about 80 people with chronic hepatitis D, a serious liver infection. Participants take the pill once daily for 48 weeks. The study aims to see if the drug is safe, how it moves through the body, and whether it can lower hepatitis D virus levels and improve liver function.

What this could mean

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

Active substance
ABI-6250, an oral tablet taken once daily for 48 weeks
What this could lead to
If successful, this could lead to a new oral treatment option for chronic hepatitis D, potentially reducing viral levels and improving liver health.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not be conclusive. The drug may cause side effects or may not effectively control the infection.
Why investors are watching

Assembly Biosciences is testing ABI-6250 in 80 people with chronic hepatitis D, a serious liver infection with few treatment options. For a micro-cap company, this phase 2 readout is a key test of whether the drug works and is safe, which could shape the company's future value.

If it works: If the trial shows ABI-6250 is safe and controls the infection, Assembly Biosciences could have a promising candidate for a disease with limited approved therapies. That result might attract partners or funding to move the drug into later-stage testing.

If it fails: Phase 2 trials often fail to show enough benefit or reveal safety problems. A negative or unclear result could set the program back and hurt the company's prospects, since it has few other products in late-stage development.

AI-written from the trial record. Speculative, and not investment advice.

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

About 80 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

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 70 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: * Participant has a body mass index ≥18.0 and \<35.0 kg/m2 at Screening * Other than HBV and HDV infection, the participant is in good health (as determined by the Investigator) based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory results. * Participant agrees to comply with protocol-specified contraception requirements. Exclusion Criteria: * Participant has a current coinfection with acute hepatitis A virus (HAV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * Participant has a history of any significant food or drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, or urticaria. * Participant has been treated for HDV infection in the past 6 months prior to Day 1. * Participant took part in another clinical trial of a drug or device (other than for HDV infection) whereby the last study drug/device administration is within 30 days or 5 half-lives, whichever is longer, prior to Day 1.

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Conditions

The condition(s) this trial relates to.

hepatitis D virus infection

As listed by the trial registrant

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

Chronic hepatitis D infection

How to take part

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

  1. The places running it

    22 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • AP-HP - Beaujon Hospital

    Clichy, France

  • ARENSIA Exploratory Medicine Ivano-Frankivsk

    Ivano-Frankivsk, Ukraine

  • Aga Khan University Hospital

    Karachi, Pakistan

  • Arensia Research Clinic

    Bucharest, Romania

  • Azienda Ospedaliera Universitaria

    Naples, Italy

  • CHU Lyon - Hôpital Croix-Rousse

    Lyon, France

  • Clinical Republican Hospital

    Chisinau, Moldova

  • Dr. Victor Babes Foundation

    Bucharest, Romania

  • Dr. Ziauddin Hospital

    Karachi, Pakistan

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Italy

  • Fundeni Clinical Institute

    Bucharest, Romania

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Spain

  • Hôpital Henri-Mondor

    Créteil, France

  • King's College Hospital London

    London, United Kingdom

  • LLC Neolab

    Tbilisi, Georgia

  • Medical Center of LLC ARENSIA Exploratory Medicine

    Kyiv, Ukraine

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • New Zealand Clinical Research

    Auckland, New Zealand

  • North Manchester General Hospital

    Manchester, United Kingdom

  • Prof. Dr. Matei Bals National Institute of Infectious Diseases

    Bucharest, Romania

  • The Royal London Hospital

    London, United Kingdom

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

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