Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Brelovitug vs Delayed Treatment for Chronic Hepatitis Delta Infection (AZURE-4)
NCT07298330Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jan 2026
- Primary completion
- Aug 2026
- Countries
- 10
- Sponsor
- Mirum Pharmaceuticals, Inc.
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- brelovitug
- Conditions
- chronic hepatitis D
01
Overview
Phase 3, randomised, open-label trial of brelovitug in chronic hepatitis D (3 arms), sponsored by Mirum Pharmaceuticals, Inc. Primary endpoint: Composite endpoint of virologic response and ALT normalization at 24 weeks. Started Jan 2026; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Brelovitug 300 mg
Brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Brelovitug 900 mg
Brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks.
Delayed treatment with brelovitug 300 mg
12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks.
03
Who it enrols
Participants must have chronic HDV infection with HDV RNA >500 IU/mL and ALT >ULN, and be willing to take or already taking HBV nucleos(t)ide therapy. Pregnant/nursing females, those with clinical hepatic decompensation, solid organ/bone marrow transplant, or other liver diseases are excluded.
04
Endpoints
Primary
Composite endpoint of virologic response and ALT normalization
Secondary
Treatment-emergent adverse events
Discontinuation of treatment due to an adverse event
HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND
HDV RNA below lower limit of quantification
HDV RNA below lower limit of quantification, Target Not Detected
Alanine aminotransferase normalization
ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or <LLOQ, TND
ALT normalization in combination with HDV RNA <LLOQ
Beyond the preview
Go deeper on NCT07298330.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT07298330.