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NCT Number: NCT07200908

A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.

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Key information

Conditions

Chronic Hepatitis D Infection Digestive System Diseases Hepatitis Hepatitis D Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Graz, Graz, Austria

Loading trial locations.

About this study

Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 to one of the following treatment arms:

Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.

Arm 2: Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Pregnant or nursing females
  • Unwilling to comply with contraception requirements during the study
  • Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
  • Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
  • Solid organ or bone marrow transplantation
  • 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.

Treatment and study plan

Brelovitug 300 mg

Drug

Route of administration- Subcutaneous Injection

Other names: BJT-778, BTG

Bulevirtide 2 mg and Brelovitug - 300 mg

Drug

Route of Administration- Subcutaneous Injection

Other names: Hepcludex

Primary outcomes

  1. Percentage of participants with a composite endpoint of virologic response and ALT normalization

    Time frame: Week 48

    The composite endpoint is defined as virologic response (undetectable HDV RNA, < the lower limit of quantification [LLOQ], target not detected [TND]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal [ULN])

Secondary outcomes

  1. Percentage of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to 96 weeks

    An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.

  2. Percentage of participants who discontinue treatment due to an adverse event (AE)

    Time frame: Up to 96 weeks

    An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.

  3. Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND

    Time frame: Up 96 Weeks

  4. Percentage of participants with HDV RNA <LLOQ

    Time frame: Up to 96 Weeks

  5. Percentage of participants with HDV RNA <LLOQ, TND

    Time frame: Up to 96 Weeks

  6. Percentage of participants with ALT normalization

    Time frame: Up to 96 Weeks

    ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN

  7. Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND

    Time frame: Up to 96 Weeks

    The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND.

  8. Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ

    Time frame: Up to 96 Weeks

    The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA <LLOQ.

  9. Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND

    Time frame: Up to 96 Weeks

    The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA <LLOQ, TND.

  10. Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan)

    Time frame: Up to 96 Weeks

  11. Change from baseline in APRI (AST-to-platelet ratio index)

    Time frame: Up to 96 Weeks

  12. Change from baseline in CTP score in participants with cirrhosis

    Time frame: Up to 96 Weeks

  13. Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis

    Time frame: Up to 96 Weeks

  14. Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease.

    Time frame: Up to 96 Weeks

    Liver disease progression will be determined by the Independent Data Monitoring Committee (IDMC).

  15. Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up.

    Time frame: Post-Treatment Weeks 24 and 48

  16. Change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Chronic Liver Disease Questionnaire-HBV (CLDQ-HBV)

    Time frame: Up to 96 Weeks

  17. Change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Time frame: Up to 96 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Clinical Trials Mirum

CONTACT

[email protected]

+16506674085

Mirum Pharmaceuticals, Inc., Clinical Trials

CONTACT

Sponsors and collaborators

Lead sponsor

Mirum Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Oct 1, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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