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Tobevibart

Phase 3

Viral Hepatitis | Small molecule | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: Jul 13, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedCONTROLLEDDMC
Total Trials3
Total Enrollment374
FDA Designations
FAST_TRACK
Clinical trial landscape

Tobevibart · 3 trials · 1 indication

Phase 3 2Phase 2 1
NCT07128550A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With BulevirtideViral Hepatitis
ACTIVE NOT_RECRUITING150 Analytics
NCT06903338A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV InfectionViral Hepatitis
ACTIVE NOT_RECRUITING124 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
Viral Hepatitis
NCT07128550150
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PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
Viral Hepatitis
NCT06903338124
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Study Endpoints
Primary Endpoints
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24
Week 24
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.
24 Weeks after End of Treatment
HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2
Up to 48 weeks
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
Up to 12 weeks
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48
Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment
24 Weeks after End of Treatment
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 48
Week 48
Secondary Endpoints
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240
Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALParticipants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Arm 2EXPERIMENTALParticipants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
Arm 1 (Tobevibart + Elebsiran)EXPERIMENTALParticipants will receive treatment with tobevibart + elebsiran for 240 weeks.
Arm 2 (Tobevibart + Elebsiran)EXPERIMENTALParticipants will receive tobevibart + elebsiran after an observational period for 240 weeks.
Interventions
NameTypeDescription
TobevibartDRUGTobevibart administered by subcutaneous injection
ElebsiranDRUGElebsiran administered by subcutaneous injection
BulevirtideDRUGBulevirtide administered by subcutaneous injection
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Eligibility Criteria
Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: 1. Male or female ages 18 to 70 years at screening 2. HDV RNA ≥ 500 IU/mL at screening 3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1 4. Noncirrhotic or compensated cirrhotic liver disease at screening 5. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or h...

Countries:AustriaFranceGermanyItalyRomaniaSpainUnited KingdomUnited StatesCanadaGeorgiaMoldovaNew ZealandPakistanUkraineBelgiumBulgariaNetherlands
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Recent Changes (Last 90 Days)
MEDIUMJul 13, 2026NCT07128550Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 13, 2026NCT07128550Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT07128550primaryCompletionDate: changed
LOWMay 26, 2026NCT06903338primaryCompletionDate: changed
LOWMay 26, 2026NCT07142811primaryCompletionDate: changed
LOWMay 24, 2026NCT07128550studyFirstPostDate: changed
LOWMay 24, 2026NCT06903338studyFirstPostDate: changed
LOWMay 24, 2026NCT07142811studyFirstPostDate: changed