A Phase 3 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection Not Virologically Suppressed with Bulevirtide (ECLIPSE 2)

Chronic Hepatitis D Virus (HDV) Infection

Part I: HDV RNA < LLOQ, TND at Week 24, Part 2: HDV RNA < LLOQ, TND 24 weeks after end of treatment

Part I: HDV RNA < LLOQ, TND at Week 48 and Week 96 Change from baseline in HDV RNA at Week 48 and Week 96, Part I: Change from baseline in ALT at Week 24, Week 48 and Week 96, Part I: Incidence of TEAEs and SAEs through Week 24, Week 48 and Week 96, Part I: • Incidence of decompensated cirrhosis (clinical event or CPT score ≥ 7) through Week 48 and Week 96 • Incidence of HCC or progression to liver failure requiring transplantation or resulting in death through Week 48 and Week 96, Part I: Change from baseline in liver stiffness as measured by liver elastography at Week 48 and Week 96, Part I: • Change from baseline in HBsAg at Week 24, Week 48 and Week 96 • Categorical summary of HBsAg at Week 24, Week 48 and Week 96, Part I: • ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 24, Week 48 and Week 96 • ALT ≤ ULN at Week 24, Week 48 and Week 96, Part I: • ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 24, Week 48 and Week 96 • ALT ≤ ULN at Week 24, Week 48 and Week 96, Part II: • HDV RNA < LLOQ, TND at Week 144, Week 192 and Week 240 • Change from baseline in HDV RNA from tobevibart+elebsiran interruption at Week 96 to Week 120, Week 144, Week 192 and Week 240, Part II: • HDV RNA < LLOQ, TND at Week 120, Week 144, Week 192 and Week 240 • Change from baseline in HDV RNA at Week 120, Week 144, Week 192 and Week 240, Part II: • Change from baseline in ALT from tobevibart+elebsiran interruption at Week 96 to Week 120, Week 144, Week 192 and Week 240, Part II: Incidence of AEs, SAEs and lab abnormalities from time of tobevibart+elebsiran interruption (Week 96) through Week 120, Week 144, Week 192 and Week 240., Part II: • Incidence of decompensation through Week 144, Week 192 and Week 240 • Incidence of HCC or progression to liver failure requiring transplantation or resulting in death through Week 144, Week 192 and Week 240, Part II: Change from baseline in liver stiffness as measured by liver elastography at Week 144, Week 192 and Week 240, Part II: Categorical summary of HBsAg at Week 120, Week 144, Week 192 and Week 240, Part II: TEAEs, SAEs through Week 120, Week 144, Week 192 and Week 240, Part II: • ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 120, Week 144, Week 192 and Week 240 • ALT ≤ ULN at Week 120, Week 144, Week 192 and Week 240, Part II: ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 120, Week 144, Week 192 and Week 240 • ALT ≤ ULN at Week 120, Week 144, Week 192 and Week 240

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