An observational study in Familial Hypercholesterolaemia and Hypercholesterolaemia, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 107 sites in Japan. Open to participants aged 15 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Novartis Pharmaceuticals · Observational
The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice
Uncontrolled, central registration system, multicenter, special drug use-results surveillance.
This is a prospective, open-label, multicenter, single-arm observational study (non-interventional study: NIS) conducted only in Japan.
The survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with Leqvio. Patients who discontinued treatment with Leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of Leqvio plus 180 days or until 24 months after the first dose of Leqvio, whichever comes earlier.
245 studies on the registry are indexed under Hyperlipoproteinemia Type II; 52 are open to participants now.
This study's enrollment of 585 is below the median of 743 across 66 observational studies indexed under Hyperlipoproteinemia Type II.
Browse Hyperlipoproteinemia Type II studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients treated with inclisiran
Exclusion Criteria:
Patients prescribed with inclisiran
Other: inclisiran
Prospective observational study. There is no treatment allocation. Patients prescribed with inclisiran are eligible to enroll into this study.
Number of patients with adverse events
To evaluate the long-term safety profile of Leqvio
Time frame: Up to 24 months
Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions
To evaluate the long-term safety profile of Leqvio
Time frame: Up to 24 months
Number of patients with adverse events leading to discontinuation of treatment with the product
To evaluate the tolerability of Leqvio
Time frame: Up to 24 months
Percent change from baseline in LDL-C levels
To evaluate the efficacy of Leqvio based on LDL-C levels
Time frame: Month 24
Showing the first 100 of 107 sites.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals