New drug combo aims to tackle stubborn hepatitis d
NCT ID NCT07128550
First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This Phase 3 trial tests whether a combination of two drugs, tobevibart and elebsiran, can suppress hepatitis D virus in adults who are still infected despite taking bulevirtide. About 150 participants will receive the combo as injections. The main goal is to see if the virus becomes undetectable in the blood after 24 weeks of treatment and stays undetectable 24 weeks after treatment ends.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tobevibart and Elebsiran (two drugs given as injections)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with chronic hepatitis D who are not responding to current therapy.
- What could go wrong
- This is an early Phase 3 trial with only 150 participants, so results may not apply to everyone. The drugs could cause side effects, and the virus might not be fully cleared.
Why investors are watching
Vir Biotechnology is running a phase 3 trial of a two-drug combination, tobevibart and elebsiran, for people with chronic hepatitis D who did not get their virus under control with the current drug bulevirtide. For a small company, this late-stage readout is a major test of whether its experimental therapy can help a difficult-to-treat group. The result will shape Vir's pipeline value and its ability to compete in a niche market.
If it works: If the combination shows strong viral suppression and a good safety profile, Vir could gain a new treatment option for hepatitis D, a disease with few approved therapies. That success could strengthen the company's position and support further development.
If it fails: Phase 3 trials often fail, and this one enrolls only 150 participants, so the results may not be conclusive. A failure or delay could hurt Vir's prospects, since the company's value depends heavily on this experimental therapy succeeding.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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. HDV RNA ≥ 500 IU/mL at screening 3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1 4. Noncirrhotic or compensated cirrhotic liver disease at screening 5. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Investigative Site
Innsbruck, 6020, Austria
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Investigative Site
Vienna, 1090, Austria
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Investigative Site
Bobigny, 93009, France
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Investigative Site
Clichy, 92110, France
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Investigative Site
Créteil, 94000, France
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Investigative Site
Le Chesnay, 78150, France
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Investigative Site
Limoges, 87000, France
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Investigative Site
Lyon, 69004, France
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Investigative Site
Montpellier, 34295, France
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Investigative Site
Pessac, 33604, France
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Investigative Site
Rennes, 35033, France
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Investigative Site
Toulouse, 31059, France
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Investigative Site
Villejuif, 94804, France
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Investigative Site
Berlin, 13353, Germany
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Investigative Site
Essen, 45147, Germany
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Investigative Site
Frankfurt am Main, 60590, Germany
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Investigative Site
Hanover, 30625, Germany
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Investigative Site
Bergamo, 24127, Italy
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Investigative Site
Foggia, 71122, Italy
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Investigative Site
Milan, 20089, Italy
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Investigative Site
Milan, 20122, Italy
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Investigative Site
Pisa, 56124, Italy
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Investigative Site
Torino, 10122, Italy
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Investigative Site
Torino, 10126, Italy
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Investigative Site
Bucharest, 021105, Romania
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Investigative Site
Bucharest, 022328, Romania
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Investigative Site
Bucharest, 030303, Romania
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Investigative Site
Craiova, 200073, Romania
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Investigative Site
Barcelona, 08035, Spain
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Investigative Site
Barcelona, 08036, Spain
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Investigative Site
Madrid, 28007, Spain
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Investigative Site
Madrid, 28046, Spain
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Investigative Site
Santander, 39008, Spain
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Investigative Site
London, E1 1FR, United Kingdom
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Investigative Site
London, SE5 9NU, United Kingdom
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Investigative Site
London, W2 1NY, United Kingdom
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Investigative Site
Manchester, M8 5RB, United Kingdom
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Investigative Site
Nottingham, NG7 2UH, United Kingdom
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