In the ORION-10 clinical
trial,
on top of a maximally
tolerated statin, LEQVIO®
demonstrated:

difference from placebo at month 17
(95% CI: -56%, -49%; P<0.0001)1
LDL-C reduction on top of a
maximally tolerated statin,
LEQVIO vs placebo1
% CHANGE IN LDL-C FROM BASELINE
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LEQVIO was also studied in the
ORION-11 (n=712) clinical trial
with similar results to
ORION-10 (n=781).1
ORION-1 ONSET
OF ACTION

Study Description: ORION-1 was a phase II, multicenter, double-blinded, randomized, placebo-controlled clinical trial of 345 subjects with established ASCVD who were taking a maximally tolerated statin and required additional LDL-C reduction. Of those, 91 patients received the 284-mg dose of LEQVIO. The primary efficacy end point was the percent reduction in LDL-C from baseline to day 180 and was calculated for multiple time points at days 14, 30, 60, 90, 120, 150, 180, 210, and 240.1,3

84% of patients treated with LEQVIO achieved
the guideline-recommended LDL-C target of
<70 mg/dL
compared with 18% of patients
treated with placebo alone at month 17 in the
ORION-10 clinical trial.4,5
LEQVIO demonstrated consistent and significant
reduction across predefined subgroups6
Percent change in LDL-C from baseline at month 17 in a pooled analysis of ORION-10 and ORION-116
*Patients with a history of statin intolerance.
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Study design
ORION-10 evaluated LDL-C
reduction over 18 months1
Trial design7
Phase III, multicenter, double-blind,
placebo controlled

Patient characteristics4,7
Characteristic
LEQVIO
(n=781)
Placebo
(n=780)
Age in years (mean)
66.4
65.7
≥65 years (%)
62.0
57.3
Diabetes mellitus
47.5
42.4
Race/Ethnicity (%)
White
83.6
87.8
Black
14.1
11.2
Asian
1.2
0.1
Hispanic/Latino
13.8
13.3
Concomitant statin therapy (%)
Statin
89.8
88.7
High-intensity statin
67.2
68.8
Not on statinª
10.2
11.3
Mean LDL-C (mg/dL)
104.5
104.8
ªPatients with a history of statin intolerance.
The clinical trial design for ORION-11
was identical to ORION-10.5
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ASCVD, atherosclerotic cardiovascular
disease; CI, confidence interval;
LDL-C, low-density lipoprotein cholesterol.