A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection (ECLIPSE 1)

Chronic Hepatitis D Virus (HDV) Infection

HDV RNA < LLOQ (lower limit of quantification), TND (target not detected) and ALT (alanine aminotransferase) normalization (ALT ≤ ULN) at Week 48 for Arm 1 vs at Week 12 for Arm 2., Primary safety Incidence of TEAEs and SAEs through Week 12.

• HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs at Week 12 for Arm 2 (key secondary endpoint). • HDV RNA < LLOQ at Week 48 for Arm 1 vs at Week 12 for Arm 2. • Change from baseline in HDV RNA at Week 48 for Arm 1 vs at Week 12 for Arm 2, • ALT ≤ ULN at Week 48 for Arm 1 vs at Week 12 for Arm 2 • ALT < 1.25 × ULN at Week 48 for Arm 1 vs at Week 12 for Arm 2 • Change from baseline in ALT at Week 48 for Arm 1 vs at Week 12 for Arm 2, • HDV RNA < LLOQ, TND and ALT < 1.25 × ULN at Week 48 for Arm 1 vs at Week 12 for Arm 2, • HDV RNA < LLOQ, TND and ALT ≤ ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • HDV RNA < LLOQ and ALT ≤ ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • HDV RNA < LLOQ, TND and ALT < 1.25 × ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment, • HDV RNA < LLOQ, TND at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • HDV RNA < LLOQ at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • Change from baseline in HDV RNA at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment, • ALT ≤ ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • ALT < 1.25 × ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • Change from baseline in ALT at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment, Change from baseline in liver stiffness as measured by liver elastography at 48, 96,144, 192 and 240 weeks of tobevibart + elebsiran treatment, • Incidence of decompensated cirrhosis (clinical event or CPT score ≥ 7) by 48, 96, 144, 192and 240 weeks of tobevibart + elebsiran treatment • Incidence of HCC and progression to liver failure requiring transplantation or resulting in death by 48, 96. 144, 192 and 240 weeks of tobevibart + elebsiran treatment., Secondary safety: Incidence of TEAEs and SAEs through 48, 96, 144, 192and 240 weeks of treatment

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