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New drug duo aims to control hard-to-treat hepatitis delta

NCT ID NCT06903338

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 study tests whether a combination of two drugs, tobevibart and elebsiran, can control chronic hepatitis delta better than waiting for treatment. About 124 adults with the infection will receive either the combo therapy or delayed treatment. The goal is to see if the combo can clear the virus and normalize liver enzyme levels.

Why investors are watching

Vir Biotechnology is running a phase 3 trial of a two-drug combination, tobevibart plus elebsiran, for chronic hepatitis delta, a rare and serious liver disease. The trial compares the combination against delayed treatment in 124 participants. For a small company like Vir, this readout is a major test of whether its lead hepatitis programs can produce a marketable therapy.

If it works: A positive result could position Vir to seek regulatory approval for the first effective treatment for hepatitis delta, giving the company a commercial product in an area with few options. That outcome would validate the company's research pipeline and support its future growth.

If it fails: The trial could fail to show that the combination works better than delayed treatment, or safety problems could emerge. Clinical trials often fail, and a negative result would likely set back Vir's hepatitis program and reduce the company's prospects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

124 people

The number who actually took part.

Started

Mar 2025

Expected to finish

May 2031

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. Chronic HDV infection for \>/= 6 months 3. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 20 IU/ml at screening, currently on locally approved NRTI therapy 4. Serum ALT \> ULN and \< 5x ULN 5. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening Exclusion Criteria: 1. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. 2. History of significant liver disease from non-HBV or non-HDV etiology 3. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. 4. History of anaphylaxis 5. History of immune complex disease 6. History of autoimmune disorder 7. History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication

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Conditions

The condition(s) this trial relates to.

hepatitis hepatitis D virus infection Hepatitis D, Chronic 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 Site

    Chandler, Arizona, 85224, United States

  • Investigative Site

    Los Angeles, California, 90033, United States

  • Investigative Site

    Redwood City, California, 94063, United States

  • Investigative Site

    San Francisco, California, 94143, United States

  • Investigative Site

    DeLand, Florida, 32720, United States

  • Investigative Site

    Chicago, Illinois, 60612, United States

  • Investigative Site

    Baltimore, Maryland, 21287, United States

  • Investigative Site

    Hillsborough, New Jersey, 08844, United States

  • Investigative Site

    New York, New York, 10016, United States

  • Investigative Site

    New York, New York, 10021, United States

  • Investigative Site

    New York, New York, 10029, United States

  • Investigative Site

    Murray, Utah, 84107, United States

  • Investigative Site

    Seattle, Washington, 98105, United States

  • Investigative Site

    Calgary, Alberta, T2N 4Z6, Canada

  • Investigative Site

    Montreal, Quebec, H2L 4E9, Canada

  • Investigative Site

    Montreal, H2X 1R9, Canada

  • Investigative Site

    Ottawa, K1H8L6, Canada

  • Investigative Site

    Québec, G1V 4G2, Canada

  • Investigative Site

    Vancouver, V6Z 2C7, Canada

  • Investigative Site

    Tbilisi, 0102, Georgia

  • Investigative Site

    Tbilisi, 0114, Georgia

  • Investigative Site

    Tbilisi, 0159, Georgia

  • Investigative Site

    Frankfurt, 60590, Germany

  • Investigative Site

    Hanover, 30625, Germany

  • Investigative Site

    Heidelberg, 69120, Germany

  • Investigative Site

    Chisinau, 2025, Moldova

  • Investigative Site

    Auckland, 1010, New Zealand

  • 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

    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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