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New drug duo takes on rare liver virus in head-to-head trial

NCT ID NCT07142811

Disease control Sponsor: Vir Biotechnology, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a combination of two experimental drugs (Tobevibart and Elebsiran) works better than the current treatment Bulevirtide for people with chronic hepatitis D, a serious liver infection. About 100 adults with stable liver disease will receive either the combo or the standard drug. The main goal is to see if the combo can make the virus undetectable in the blood and keep it that way for 24 weeks after treatment ends.

Why investors are watching

Vir Biotechnology is running a phase 2b trial testing a combination of two drugs, Tobevibart and Elebsiran, against an existing treatment called bulevirtide in 100 people with chronic hepatitis D. For a small company like Vir, this readout matters because it could show whether their combination works better than the current option, which would give them a stronger position in a niche market with few treatments.

If it works: If the combination shows better efficacy or safety than bulevirtide, Vir could advance the drugs toward approval and capture a meaningful share of the hepatitis D treatment market. A positive result would also validate the company's research approach and potentially attract partnership interest.

If it fails: If the trial fails or shows no advantage over bulevirtide, Vir would likely abandon the program, losing years of investment and a key pipeline asset. Trials fail often, and a negative result could hurt the company's credibility and financial outlook.

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 100 people

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

Started

Aug 2025

Expected to finish

Jul 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 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: 1. Male or female ages 18 to 70 years at screening 2. Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening 3. Noncirrhotic or compensated cirrhotic liver disease at screening 4. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 10 IU/ml at screening, currently on locally approved NRTI therapy Exclusion Criteria: 1. Serum ALT ≥ 5 × ULN 2. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. 3. History of significant liver disease from non-HBV or non-HDV etiology 4. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. 5. History of anaphylaxis 6. History of immune complex disease 7. History of autoimmune disorder 8. Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids. 9. Any previous treatment with Bulivertide

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases hepatitis hepatitis D virus infection Hepatitis D, Chronic liver disorder viral hepatitis

As listed by the trial registrant

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

Viral hepatitis

Contacts and locations

Locations

  • Investigative

    Valencia, 46014, Spain

  • Investigative Site

    Brussels, 1020, Belgium

  • Investigative Site

    Brussels, 1070, Belgium

  • Investigative Site

    Edegem, 2650, Belgium

  • Investigative Site

    Sofia, 1407, Bulgaria

  • Investigative Site

    Sofia, 1431, Bulgaria

  • Investigative Site

    Stara Zagora, 6003, Bulgaria

  • Investigative Site

    Clichy, 92110, France

  • Investigative Site

    Créteil, 94000, France

  • Investigative Site

    Limoges, 87042, France

  • Investigative Site

    Rennes, 35000, France

  • Investigative Site

    Toulouse, 31059, France

  • Investigative Site

    Hanover, 30625, Germany

  • Investigative Site

    Chisinau, 2025, Moldova

  • Investigative Site

    Amsterdam, 1081 HV, Netherlands

  • Investigative Site

    Nijmegen, 6525 GA, Netherlands

  • Investigative Site

    Rotterdam, 3015 GD, Netherlands

  • Investigative Site

    Karachi, 74800, Pakistan

  • Investigative Site

    Karachi, 75600, Pakistan

  • Investigative Site

    Lahore, 54800, Pakistan

  • Investigative Site

    Rawalpindi, 46000, Pakistan

  • Investigative Site

    Bucharest, 021105, Romania

  • Investigative Site

    Bucharest, 022328, Romania

  • Investigative Site

    Bucharest, 030303, Romania

  • Investigative Site

    Barcelona, 08028, Spain

  • Investigative Site

    Madrid, 28064, Spain

  • Investigative Site

    Kyiv, 01135, Ukraine

  • Investigative Site

    London, E1 1BB, United Kingdom

  • Investigative Site

    London, SE5 9RS, United Kingdom

  • Investigative Site

    Manchester, M8 5RB, United Kingdom

  • Investigative Site

    Nottingham, NG7 2UH, United Kingdom

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