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Brelovitug versus delayed treatment for chronic Hepatitis D

A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

Phase 3 Interventional Mirum Pharmaceuticals, Inc. · NCT07298330

This test sees if weekly or monthly brelovitug reduces HDV levels and helps people with chronic Hepatitis D compared with starting treatment after 12 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorMirum Pharmaceuticals, Inc. Industry-sponsored
Locations27 sites (Davis, California and 26 other locations)
Trial IDNCT07298330 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, open-label, multicenter trial that will enroll about 80 participants and randomize them 2:1:1 into three arms. One group receives brelovitug 300 mg subcutaneously once weekly for 96 weeks, a second receives brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks, and a third delays brelovitug for 12 weeks before starting 300 mg weekly for 96 weeks. The trial will monitor safety and antiviral effect over the treatment period with regular clinic visits and blood testing. The primary comparisons focus on on-treatment HDV RNA changes and liver-related safety outcomes across dosing regimens and versus delayed start.

Who should consider this trial

Good fit: People with chronic HDV infection who have HDV RNA >500 IU/mL, elevated ALT, and who are willing to take or are already taking HBV nucleos(t)ide therapy and can attend study visits.

Not a fit: Patients with clinical hepatic decompensation, other non-HBV/HDV liver diseases, prior solid organ or bone marrow transplant, pregnancy, or those unable to undergo required blood draws are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, brelovitug could lower HDV viral load, improve liver tests, and slow progression of liver disease for people with chronic Hepatitis D.

How similar studies have performed: Early-phase studies of brelovitug have shown antiviral activity in HDV, but Phase 3 confirmation of long-term clinical benefit is still pending.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 nucleos(t)ide therapy.

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 metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.

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

Where this trial is running

Davis, California and 26 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 Chronic Hepatitis D InfectionHepatitis Delta virusHDVHepatitis D infectionHepatitis D virus
Last reviewed 2026-06-15 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.