Trial Outcomes & Findings for Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia (NCT NCT05192941)

This study had a screening period of approximately 14 days for all participants. Participants must have been on a stable dose of statin for ≥ 30 days prior to the screening visit.

Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

Number of participants achieving individual Low-density Lipoprotein Cholesterol (LDL-C) target (\< 55 mg/dL or \< 70 mg/dL) at Day 90. The individual LDL-C target of the participants was determined according to their most recent individual cardiovascular risk category. A larger proportion of participants indicates a superior outcome.

Relative (percentage) change from baseline in Low-density Lipoprotein Cholesterol (LDL-C) level averaged over the double-blind treatment period

The number of participants who experienced at least one muscle-related adverse event, defined as Standardized MedDRA Queries (SMQ) rhabdomyolysis / myopathy from Day 1 to Day 360. All muscle-related adverse events occurring between first dose of double-blind treatment and earliest date out of visit Day 360, death date and last contact date are considered.

Self-reported pain is reported at its worst in the last 24 h on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). Days with a score of 0 are considered as days without pain. The percentage of days with pain for each participant is calculated as number of days with pain divided by the total number of days where diary was completed, multiplied by 100. Diary data between the first dose of double-blind treatment up to the minimum of last contact date and Day 360 visit are considered.

Annualized rate refers to the estimated number of days with pain per year. Self-reported pain is reported at its worst in the last 24 h on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). Days with a score of 0 are considered as days without pain.

The Short-Form Brief Pain Inventory (SF-BPI) is a self-administered standardized fifteen items questionnaire that assesses how pain interferes with or influences a participant's life. The query period covers the past 24 hours and takes 5 minutes for the participant to complete. The pain severity score was derived for each visit between screening and EOT/EOS (Day 360) as the average over the 4 items in the pain severity domain (questionnaire items number 3, 4, 5, 6). The derived pain severity score ranged between 0 (no pain) and 10 (pain as bad as you can imagine), with larger values indicating a higher level of pain severity (worse outcome). If there was missing data for a participant and the available data was more than 50% for the corresponding domain (3 of 4 \[pain severity\] ), the missing items were imputed using the mean score of the non-missing item scores.

The Short-Form Brief Pain Inventory (SF-BPI) is a self-administered standardized fifteen items questionnaire that assesses how pain interferes with or influences a participant's life. The query period covers the past 24 hours and takes 5 minutes for the participant to complete. The pain interference score was derived for each visit between screening and EOT/EOS (Day 360) as the average over the 7 items in the pain interference domain (questionnaire items number 9A through 9G). The derived pain interference score ranged between 0 (does not interfere) and 10 (completely interferes), with larger values indicating a higher level of pain interference (worse outcome). If there was missing data for a participant and the available data was more than 50% for the corresponding domain (4 of 7 \[pain interference\] ), the missing items were imputed using the mean score of the non-missing item scores.

The Short-Form Brief Pain Inventory (SF-BPI) is a self-administered standardized fifteen items questionnaire that assesses how pain interferes with or influences a participant's life. The query period covers the past 24 hours and takes 5 minutes for the participant to complete. The pain severity score was derived for each visit between screening and EOT/EOS (Day 360) as the average over the 4 items in the pain severity domain (questionnaire items number 3, 4, 5, 6). The derived pain severity score ranged between 0 (no pain) and 10 (pain as bad as you can imagine), with larger values indicating a higher level of pain severity (worse outcome). A clinically relevant change is defined by a reduction from baseline in SF-BPI pain severity score by at least 2 points. If there was missing data for a participant and the available data was more than 50% for the corresponding domain (3 of 4 \[pain severity\] ), the missing items were imputed using the mean score of the non-missing item scores.

The SF-BPI is a self-administered standardized fifteen items questionnaire that assesses how pain interferes with or influences a participant's life. The query period covers the past 24 hours and takes 5 minutes for the participant to complete. The pain interference score was derived for each visit between screening and EOT/EOS (Day 360) as the average over the 7 items in the pain interference domain (questionnaire items number 9A through 9G). The derived pain interference score ranged between 0 (does not interfere) and 10 (completely interferes), with larger values indicating a higher level of pain interference (worse outcome). A clinically relevant change is defined by a reduction from baseline in SF-BPI pain interference score by at least 2 points. If there was missing data for a participant and the available data was more than 50% for the corresponding domain (4 of 7 \[pain interference\] ), the missing items were imputed using the mean score of the non-missing item scores.