Will the Phase 2 Trials of Lepodisiran be a Success?

Resolves as YES if the Phase 2 trials of Lepodisiran demonstrate:

  1. Efficacy: The trials must show a statistically significant reduction in lipoprotein(a) [Lp(a)] levels in participants compared to baseline, achieving at least a 50% reduction in median Lp(a) levels. The specific criteria include:

    • A high percentage of participants achieving Lp(a) levels below 125 nmol/L and 75 nmol/L.

    • Consistent reduction of Lp(a) levels maintained over the trial period.

  2. Safety: The trials must confirm that Lepodisiran is safe for participants, with no significant adverse events that would outweigh the benefits. This includes:

    • Minimal and manageable side effects.

    • Few serious adverse events linked to the drug's administration.

  3. Regulatory Progress: The trial results must be sufficient to warrant progression to Phase 3 trials as determined by the relevant regulatory bodies or the sponsoring company (Eli Lilly).

Background: Lepodisiran is a small interfering RNA (siRNA) therapeutic designed to reduce the production of Lp(a) in the liver by targeting the mRNA that encodes apolipoprotein(a). Elevated Lp(a) levels are a known risk factor for atherosclerotic cardiovascular disease (ASCVD), and effective reduction of these levels could significantly impact patient outcomes.

The ongoing Phase 2 trial (NCT05565742), which started in October 2022, is crucial for determining the drug's efficacy and safety profile. Results are expected to be published by 2025​ (American Heart Association)​​ (Cleveland Clinic)​​ (Home - ClinicalTrials.gov)​.

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