This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
Male or female ages 18 to 70 years at screening
HDV RNA ≥ 500 IU/mL at screening
Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
Noncirrhotic or compensated cirrhotic liver disease at screening
Serum ALT ≥ 5 × ULN
Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
History of significant liver disease from non-HBV or non-HDV etiology
History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
Parallel
Tobevibart
DrugTobevibart administered by subcutaneous injection
Elebsiran
DrugElebsiran administered by subcutaneous injection
Bulevirtide
DrugBulevirtide administered by subcutaneous injection
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.
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
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
Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
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