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Brelovitug versus bulevirtide for treating chronic hepatitis D (AZURE-2)

A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

PHASE3 · Mirum Pharmaceuticals, Inc. · NCT07200908

This trial tests whether weekly brelovitug works better than daily bulevirtide followed by weekly brelovitug for adults with chronic hepatitis D who are on HBV nucleos(t)ide therapy.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment172 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorMirum Pharmaceuticals, Inc. (industry)
Locations44 sites (Graz and 43 other locations)
Trial IDNCT07200908 on ClinicalTrials.gov

What this trial studies

This Phase 3, global, randomized, open-label, multicenter trial will enroll about 172 adults with chronic HDV infection and randomize them 3:1 to two treatment arms. One arm receives brelovitug 300 mg subcutaneously once weekly for 96 weeks; the other receives bulevirtide 2 mg subcutaneously once daily for 48 weeks followed by brelovitug 300 mg weekly for the next 48 weeks. All participants must be on or willing to start HBV nucleos(t)ide therapy and will have regular blood testing for HDV RNA and liver function. The study compares long-term virologic and biochemical responses and safety between continuous brelovitug and the sequential bulevirtide-then-brelovitug regimen.

Who should consider this trial

Good fit: Adults with chronic HDV infection who have HDV RNA >500 IU/mL, elevated ALT, can adhere to HBV nucleos(t)ide therapy and study visits, and can meet contraception and blood-draw requirements.

Not a fit: People with clinical hepatic decompensation, other significant non-HBV liver diseases, prior organ transplant, pregnant or nursing women, or those unable to comply with blood sampling or contraception are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, brelovitug could offer a more convenient weekly treatment that better suppresses HDV and reduces liver inflammation over the long term.

How similar studies have performed: Bulevirtide has shown clinical benefit in earlier trials and is approved in some regions, while brelovitug is a newer agent currently in late-stage testing with promising but not yet definitive data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Chronic HDV infection
3. HDV RNA \>500 IU/mL at Screening
4. ALT \>ULN at Screening
5. Willing to take or already taking HBV neucleos(t)ide therapy.

Key Exclusion Criteria:

1. Pregnant or nursing females
2. Unwilling to comply with contraception requirements during the study
3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
5. Solid organ or bone marrow transplantation
6. Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.

Note - Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Graz and 43 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 →

Conditions: Chronic Hepatitis D Infection, Hepatitis Delta virus, HDV, Hepatitis D infection, Hepatitis D virus

Last reviewed 2026-05-15 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.