A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

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

This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis D Infection
• Intervention / Treatment: Drug: Brelovitug 300 mg; Drug: Brelovitug 900 mg; Drug: Delayed Treatment with Brelovitug 300mg

Detailed Description

The study consists of 3 study arms. Approximately 80 participants will be randomized 2:1:1 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 brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks.

Arm 3: Participants will attend study clinic visits and delay treatment with brelovitug for 12 weeks. At Week 12, participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Mirum; Phone Number: +16506674085; Email: clinicaltrials@mirumpharma.com
• Study Contact Backup: Name: Mirum Pharmaceuticals, Inc., Clinical Trials

Study Locations

• Belgium
  • Brussels, Belgium
    • Recruiting
    • Erasme Hospital
  • Edegem, Belgium
    • Recruiting
    • University Hospital Antwerp (UZA)
  • Liège, Belgium
    • Recruiting
    • University Hospital Center Sart-Tilman
• Bulgaria
  • Sofia, Bulgaria, 1407
    • Recruiting
    • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda
• Georgia
  • Kutaisi, Georgia, 4608
    • Recruiting
    • Hospital Service LTD
  • Tbilisi, Georgia, 0159
    • Recruiting
    • Diakori LLC
  • Tbilisi, Georgia, 0159
    • Recruiting
    • JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center
  • Tbilisi, Georgia, 0160
    • Recruiting
    • LTD Academician Vakhtang Bochorishvili Clinic
• Hungary
  • Budapest, Hungary, H-1097
    • Recruiting
    • Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases
  • Székesfehérvár, Hungary, H-8000
    • Recruiting
    • Fejer County St. Gyorgy University Teaching Hospital
• Israel
  • Beersheba, Israel, 8410101
    • Recruiting
    • Soroka University Medical Center
  • Haifa, Israel, 3296043
    • Recruiting
    • HaEmek Medical Center
• Pakistan
  • Karachi
    • Karachi, Karachi, Pakistan, 74800
      • Recruiting
      • Aga Khan University & Hospital
• Taiwan
  • Kaohsiung City, Taiwan, 82445
    • Recruiting
    • E-DA Hospital
  • Kaohsiung City, Taiwan, 807377
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taipei, Taiwan, 100225
    • Recruiting
    • National Taiwan University Hospital
• Ukraine
  • Poltava, Ukraine, 36000
    • Recruiting
    • Limited Liability Company "Medical Center Health and Rehabilitation "100 Percent Life"
  • Rivne, Ukraine, 33018
    • Recruiting
    • Public Non-Profit Enterprise "Central City Hospital" of Rivne City Council
• United States
  • California
    • Davis, California, United States, 95616
      • Recruiting
      • University of California, Davis
    • Sacramento, California, United States, 95661
      • Recruiting
      • Kaiser Permanente Medical Center
    • San Francisco, California, United States, 94115
      • Recruiting
      • Quest Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89019
      • Recruiting
      • Alliance Clinical, Las Vegas
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Texas
    • Mansfield, Texas, United States, 76063
      • Recruiting
      • Prime Clinical Research Inc
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah
• Uzbekistan
  • Tashkent, Uzbekistan, 100194
    • Recruiting
    • Research Institute of Virology of the Republic of Uzbekistan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brelovitug 300 mg; Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks	Drug: Brelovitug 300 mg; Route of administration- Subcutaneous Injection; Other Names: BJT-778; BTG
Experimental: Brelovitug 900 mg; Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks	Drug: Brelovitug 900 mg; Route of administration- Subcutaneous Injection; Other Names: BJT-778; BTG
Active Comparator: Delayed treatment with brelovitug 300 mg; Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks	Drug: Delayed Treatment with Brelovitug 300mg; Route of administration- Subcutaneous Injection; Other Names: BJT-778; BTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm	The composite endpoint is defined as virologic response (HDV RNA ≥2 log10 IU/mL decrease from Baseline or 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])	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with treatment-emergent adverse events (TEAEs)	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.	Up to 96 weeks
Percentage of participants who discontinue treatment due to an adverse event (AE)	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.	Up to 96 weeks
Percentage of participants with HDV RNA <LLOQ		Up to 96 Weeks
Percentage of participants with HDV RNA <LLOQ, TND		Up to 96 Weeks
Percentage of participants with ALT normalization	ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN	Up to 96 Weeks
Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND	The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA <LLOQ, TND.	Up to 96 Weeks
Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan)		Up to 96 Weeks
Change from baseline in APRI (AST-to-platelet ratio index)		Up to 96 Weeks
Change from baseline in CTP score in participants with cirrhosis		Up to 96 Weeks
Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis		Up to 96 Weeks
Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease.	Liver disease progression will be determined by the Independent Data Monitoring Committee (IDMC).	Up to 96 Weeks
Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up.		Post-Treatment Weeks 24 and 48
Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND		Up to 96 Weeks
Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or <LLOQ, TND	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.	Up to 96 Weeks
Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ	The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA <LLOQ	Up to 96 Weeks

Collaborators and Investigators

• Sponsor: Mirum Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: HDV; Hepatitis Delta virus; Hepatitis D infection; Hepatitis D virus
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepatitis; Hepatitis D; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Time-to-Treatment; Treatment Delay
• Other Study ID Numbers: BJT-778-304; 2025-522105-38-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No