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Tobevibart plus elebsiran for adults with chronic Hepatitis D not controlled by bulevirtide

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)

Phase 3 Interventional Vir Biotechnology, Inc. · NCT07128550

This test tries whether adding tobevibart plus elebsiran can lower Hepatitis D virus levels in adults whose infection isn't suppressed by bulevirtide.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorVir Biotechnology, Inc. Industry-sponsored
Locations38 sites (Innsbruck and 37 other locations)
Trial IDNCT07128550 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label, randomized Phase 3 study enrolling adults with chronic HDV infection who remain viremic despite at least 24 weeks of bulevirtide (BLV) therapy. Eligible participants must have HDV RNA ≥ 500 IU/mL, be 18–70 years old, have noncirrhotic or compensated cirrhotic liver disease, and be on HBV NRTI therapy or have HBV DNA < 10 IU/mL. Participants will be randomized to receive tobevibart plus elebsiran in the context of ongoing BLV to determine whether the combination achieves greater viral suppression than current management. Safety monitoring will include liver enzyme checks and review of immune-related exclusion criteria such as autoimmune disease or prior severe hypersensitivity.

Who should consider this trial

Good fit: Adults 18–70 with chronic HDV infection who have HDV RNA ≥ 500 IU/mL and have been on bulevirtide 2 mg SC daily for at least 24 weeks, with noncirrhotic or compensated cirrhotic liver disease and appropriate HBV control, are ideal candidates.

Not a fit: Patients with marked liver enzyme elevation (ALT ≥ 5× ULN), decompensated liver disease, significant non-HBV/non-HDV liver disease, autoimmune or immune complex disorders, history of anaphylaxis, or recent immunosuppressive therapy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could reduce HDV RNA levels and increase the chance of sustained viral suppression, which may slow liver disease progression.

How similar studies have performed: Early-phase trials combining entry inhibitors or novel antivirals for HDV have shown promise at reducing HDV RNA, but the specific tobevibart plus elebsiran combination is novel and not yet established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Innsbruck and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Viral HepatitisHDVHepatitis D VirusHepatitisChronic Hepatitis D VirusHepatitis DHepatitis D, ChronicHepatitis Delta Virus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.