NCT04666298 (ORION-15) is a Phase 2 clinical trial of Inclisiran sodium in Hypercholesterolemia, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT04666298?

NCT04666298 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT04666298?

Interventions in NCT04666298: Inclisiran sodium, Placebo.

What condition does NCT04666298 study?

NCT04666298 studies Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia.

Is NCT04666298 still recruiting?

NCT04666298 is currently completed. Last updated 20 June 2024.

Are results published for NCT04666298?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-20 · How we verify

NCT04666298: ORION-15

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

Completed Phase 2 Results posted Last updated 20 June 2024

What this trial tests

Phase 2 trial testing Inclisiran sodium in Hypercholesterolemia in 312 participants. Completed in 19 October 2022.

Timeline

29 January 2021

Primary endpoint
18 April 2022

19 October 2022

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	312
Start date	29 January 2021
Primary completion	18 April 2022
Estimated completion	19 October 2022
Sites	42 locations across Japan

Drugs / interventions tested

Inclisiran sodium — full drug profile →
Placebo

Conditions studied

Hypercholesterolemia — all drugs for Hypercholesterolemia →
Heterozygous Familial Hypercholesterolemia — all drugs for Heterozygous Familial Hypercholesterolemia →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

20 and older, any sex, with Hypercholesterolemia or Heterozygous Familial Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180 Primary · Baseline, Day 180

Percent change from baseline in LDL-C was calculated to evaluate the effect of inclisiran at Day 180. Difference between different inclisiran dose groups and the placebo group in percentage change in LDL-C levels from baseline to Day 180 were calculated to capture both, the effect of the study drug and the effect of additional medications, mirroring the conditions in clinical practice. An MMRM (Mixed-effect Model with Repeated Measurement) was used as the primary analysis model, with treatment group, visits, interaction between visits and treatment groups, current use of statins or other lip

Group	Value	95% CI
Placebo	9.0	3.5 – 14.5
100 mg Inclisiran Sodium	-47.6	-53.4 – -41.8
200 mg Inclisiran Sodium	-51.9	-56.8 – -47.0
300 mg Inclisiran Sodium	-56.3	-61.1 – -51.4

Percent Change From Baseline in PCSK9 by Visit Secondary · Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180

Percent change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) was calculated to evaluate the effect of inclisiran over time.

Day 14

Group	Value	95% CI
Placebo	4.79	± 21.623
100 mg Inclisiran Sodium	-55.42	± 19.980
200 mg Inclisiran Sodium	-65.64	± 13.677
300 mg Inclisiran Sodium	-69.56	± 11.387

Day 30

Group	Value	95% CI
Placebo	1.92	± 22.427
100 mg Inclisiran Sodium	-66.45	± 12.341
200 mg Inclisiran Sodium	-72.94	± 8.809
300 mg Inclisiran Sodium	-76.46	± 8.561

Day 60

Group	Value	95% CI
Placebo	-0.16	± 22.656
100 mg Inclisiran Sodium	-62.56	± 15.356
200 mg Inclisiran Sodium	-73.23	± 10.692
300 mg Inclisiran Sodium	-76.52	± 9.953

Day 90

Group	Value	95% CI
Placebo	2.12	± 21.447
100 mg Inclisiran Sodium	-59.76	± 14.503
200 mg Inclisiran Sodium	-70.49	± 10.806
300 mg Inclisiran Sodium	-73.09	± 11.525

Day 104

Group	Value	95% CI
Placebo	2.65	± 28.624
100 mg Inclisiran Sodium	-69.05	± 11.109
200 mg Inclisiran Sodium	-76.23	± 9.017
300 mg Inclisiran Sodium	-78.55	± 8.052

Day 120

Group	Value	95% CI
Placebo	0.99	± 21.572
100 mg Inclisiran Sodium	-70.29	± 11.543
200 mg Inclisiran Sodium	-77.03	± 8.206
300 mg Inclisiran Sodium	-79.80	± 6.994

Day 150

Group	Value	95% CI
Placebo	2.34	± 23.353
100 mg Inclisiran Sodium	-66.02	± 12.724
200 mg Inclisiran Sodium	-73.94	± 17.139
300 mg Inclisiran Sodium	-77.12	± 8.770

Day 180

Group	Value	95% CI
Placebo	2.78	± 21.226
100 mg Inclisiran Sodium	-63.62	± 14.012
200 mg Inclisiran Sodium	-70.99	± 10.495
300 mg Inclisiran Sodium	-75.97	± 9.885

Percent Change From Baseline in LDL-C by Visit Secondary · Baseline, day 14, day 30, day 60, day 90, day 104, day 120 and day 150

Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran over time.

Day 14

Group	Value	95% CI
Placebo	1.68	± 18.099
100 mg Inclisiran Sodium	-37.15	± 21.855
200 mg Inclisiran Sodium	-42.08	± 20.503
300 mg Inclisiran Sodium	-47.60	± 19.889

Day 30

Group	Value	95% CI
Placebo	1.29	± 13.068
100 mg Inclisiran Sodium	-52.20	± 18.389
200 mg Inclisiran Sodium	-55.54	± 17.501
300 mg Inclisiran Sodium	-62.77	± 15.097

Day 60

Group	Value	95% CI
Placebo	0.24	± 15.314
100 mg Inclisiran Sodium	-50.06	± 19.173
200 mg Inclisiran Sodium	-55.61	± 17.570
300 mg Inclisiran Sodium	-62.35	± 13.976

Day 90

Group	Value	95% CI
Placebo	2.69	± 14.332
100 mg Inclisiran Sodium	-46.39	± 17.872
200 mg Inclisiran Sodium	-53.92	± 17.186
300 mg Inclisiran Sodium	-61.51	± 15.480

Day 104

Group	Value	95% CI
Placebo	1.20	± 13.519
100 mg Inclisiran Sodium	-53.00	± 19.001
200 mg Inclisiran Sodium	-60.33	± 15.912
300 mg Inclisiran Sodium	-65.68	± 15.321

Day 120

Group	Value	95% CI
Placebo	2.26	± 14.854
100 mg Inclisiran Sodium	-54.91	± 19.410
200 mg Inclisiran Sodium	-62.04	± 16.742
300 mg Inclisiran Sodium	-67.23	± 16.017

Day 150

Group	Value	95% CI
Placebo	4.27	± 16.983
100 mg Inclisiran Sodium	-55.46	± 18.817
200 mg Inclisiran Sodium	-60.55	± 16.502
300 mg Inclisiran Sodium	-66.15	± 15.197

Absolute Change in LDL-C From Baseline at Day 180 Secondary · Baseline, Day 180

Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran until Day 180.

Group	Value	95% CI
Placebo	13.2	6.6 – 19.8
100 mg Inclisiran Sodium	-49.3	-56.2 – -42.3
200 mg Inclisiran Sodium	-53.9	-59.8 – -48.0
300 mg Inclisiran Sodium	-57.7	-63.5 – -51.8

Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180 Secondary · Baseline, Day 180

Proportion of participants with LDL-C greater than 80% of baseline value at Day 180 was calculated to evaluate the effect of inclisiran until Day 180. Subjects are counted if the LDL-C value is greater than '0.8\*(LDL-C at Baseline - LDL-C at Day180) + LDL-C at Day180', or the LDL-C value is greater than or equal to the LDL-C at Baseline.

Group	Value	95% CI
Placebo	35
100 mg Inclisiran Sodium	0
200 mg Inclisiran Sodium	0
300 mg Inclisiran Sodium	0

Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit Secondary · Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180

Proportion of participants with greater or equal to 50% LDL-C reduction from baseline was calculated to evaluate the effect of inclisiran over time.

Day 14

Group	Value	95% CI
Placebo	1
100 mg Inclisiran Sodium	17
200 mg Inclisiran Sodium	40
300 mg Inclisiran Sodium	45

Day 30

Group	Value	95% CI
Placebo	0
100 mg Inclisiran Sodium	31
200 mg Inclisiran Sodium	63
300 mg Inclisiran Sodium	83

Day 60

Group	Value	95% CI
Placebo	0
100 mg Inclisiran Sodium	26
200 mg Inclisiran Sodium	64
300 mg Inclisiran Sodium	75

Day 90

Group	Value	95% CI
Placebo	0
100 mg Inclisiran Sodium	22
200 mg Inclisiran Sodium	58
300 mg Inclisiran Sodium	76

Day 104

Group	Value	95% CI
Placebo	0
100 mg Inclisiran Sodium	32
200 mg Inclisiran Sodium	77
300 mg Inclisiran Sodium	82

Day 120

Group	Value	95% CI
Placebo	0
100 mg Inclisiran Sodium	37
200 mg Inclisiran Sodium	72
300 mg Inclisiran Sodium	82

Day 150

Group	Value	95% CI
Placebo	0
100 mg Inclisiran Sodium	35
200 mg Inclisiran Sodium	73
300 mg Inclisiran Sodium	78

Day 180

Group	Value	95% CI
Placebo	0
100 mg Inclisiran Sodium	33
200 mg Inclisiran Sodium	68
300 mg Inclisiran Sodium	73

Percent Change From Baseline in Cholesterol by Visit Secondary · Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180

Percent change from baseline in cholesterol by visit was calculated to evaluate the effect of inclisiran over time

Day 14

Group	Value	95% CI
Placebo	0.87	± 10.399
100 mg Inclisiran Sodium	-21.94	± 14.034
200 mg Inclisiran Sodium	-24.71	± 12.917
300 mg Inclisiran Sodium	-28.60	± 12.476

Day 30

Group	Value	95% CI
Placebo	0.89	± 9.003
100 mg Inclisiran Sodium	-30.92	± 12.558
200 mg Inclisiran Sodium	-32.90	± 11.739
300 mg Inclisiran Sodium	-37.09	± 10.227

Day 60

Group	Value	95% CI
Placebo	0.31	± 8.885
100 mg Inclisiran Sodium	-29.47	± 13.426
200 mg Inclisiran Sodium	-33.71	± 12.291
300 mg Inclisiran Sodium	-37.01	± 9.948

Day 90

Group	Value	95% CI
Placebo	1.03	± 8.952
100 mg Inclisiran Sodium	-27.30	± 13.127
200 mg Inclisiran Sodium	-32.26	± 12.103
300 mg Inclisiran Sodium	-36.34	± 10.655

Day 104

Group	Value	95% CI
Placebo	1.62	± 10.178
100 mg Inclisiran Sodium	-30.72	± 13.239
200 mg Inclisiran Sodium	-35.63	± 11.875
300 mg Inclisiran Sodium	-39.53	± 10.468

Day 120

Group	Value	95% CI
Placebo	1.11	± 10.860
100 mg Inclisiran Sodium	-32.24	± 13.575
200 mg Inclisiran Sodium	-36.24	± 12.995
300 mg Inclisiran Sodium	-39.38	± 10.165

Day 150

Group	Value	95% CI
Placebo	2.41	± 10.801
100 mg Inclisiran Sodium	-32.20	± 14.246
200 mg Inclisiran Sodium	-35.70	± 11.980
300 mg Inclisiran Sodium	-38.12	± 10.850

Day 180

Group	Value	95% CI
Placebo	2.78	± 10.272
100 mg Inclisiran Sodium	-30.22	± 12.468
200 mg Inclisiran Sodium	-32.95	± 12.540
300 mg Inclisiran Sodium	-35.46	± 11.941

Percent Change From Baseline in Triglycerides by Visit Secondary · Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180

Percent change from baseline in triglycerides by visit was calculated to evaluate the effect of inclisiran over time

Day 14

Group	Value	95% CI
Placebo	5.49	± 28.803
100 mg Inclisiran Sodium	1.24	± 29.630
200 mg Inclisiran Sodium	-1.16	± 51.241
300 mg Inclisiran Sodium	-7.19	± 23.817

Day 30

Group	Value	95% CI
Placebo	7.76	± 35.248
100 mg Inclisiran Sodium	-4.72	± 25.843
200 mg Inclisiran Sodium	-8.69	± 25.450
300 mg Inclisiran Sodium	-8.37	± 28.240

Day 60

Group	Value	95% CI
Placebo	9.68	± 37.000
100 mg Inclisiran Sodium	-7.17	± 28.427
200 mg Inclisiran Sodium	-9.26	± 27.598
300 mg Inclisiran Sodium	-9.93	± 26.405

Day 90

Group	Value	95% CI
Placebo	6.83	± 33.204
100 mg Inclisiran Sodium	-1.87	± 40.499
200 mg Inclisiran Sodium	-12.17	± 26.204
300 mg Inclisiran Sodium	-9.99	± 29.230

Day 104

Group	Value	95% CI
Placebo	11.86	± 37.365
100 mg Inclisiran Sodium	-7.12	± 26.145
200 mg Inclisiran Sodium	-5.81	± 55.419
300 mg Inclisiran Sodium	-13.51	± 26.915

Day 120

Group	Value	95% CI
Placebo	3.57	± 33.870
100 mg Inclisiran Sodium	-9.40	± 27.192
200 mg Inclisiran Sodium	-9.32	± 33.471
300 mg Inclisiran Sodium	-12.33	± 26.280

Day 150

Group	Value	95% CI
Placebo	3.33	± 32.023
100 mg Inclisiran Sodium	-5.60	± 42.988
200 mg Inclisiran Sodium	-12.65	± 24.766
300 mg Inclisiran Sodium	-11.81	± 28.623

Day 180

Group	Value	95% CI
Placebo	-0.19	± 32.161
100 mg Inclisiran Sodium	-2.34	± 33.783
200 mg Inclisiran Sodium	-12.11	± 39.414
300 mg Inclisiran Sodium	-13.67	± 27.307

Percent Change From Baseline in HDL Cholesterol by Visit Secondary · Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180

Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) by visit was calculated to evaluate the effect of inclisiran over time

Day 14

Group	Value	95% CI
Placebo	1.73	± 8.765
100 mg Inclisiran Sodium	3.00	± 10.745
200 mg Inclisiran Sodium	5.93	± 12.164
300 mg Inclisiran Sodium	4.38	± 10.727

Day 30

Group	Value	95% CI
Placebo	1.94	± 11.259
100 mg Inclisiran Sodium	4.86	± 10.450
200 mg Inclisiran Sodium	9.89	± 13.656
300 mg Inclisiran Sodium	8.43	± 12.740

Day 60

Group	Value	95% CI
Placebo	0.57	± 10.677
100 mg Inclisiran Sodium	6.80	± 15.222
200 mg Inclisiran Sodium	8.02	± 15.411
300 mg Inclisiran Sodium	9.15	± 14.984

Day 90

Group	Value	95% CI
Placebo	0.56	± 11.543
100 mg Inclisiran Sodium	6.51	± 16.297
200 mg Inclisiran Sodium	10.86	± 16.359
300 mg Inclisiran Sodium	8.59	± 16.546

Day 104

Group	Value	95% CI
Placebo	1.35	± 14.817
100 mg Inclisiran Sodium	8.69	± 15.303
200 mg Inclisiran Sodium	11.04	± 16.443
300 mg Inclisiran Sodium	8.99	± 17.280

Day 120

Group	Value	95% CI
Placebo	4.20	± 13.747
100 mg Inclisiran Sodium	8.84	± 13.432
200 mg Inclisiran Sodium	12.65	± 16.777
300 mg Inclisiran Sodium	11.97	± 18.300

Day 150

Group	Value	95% CI
Placebo	5.12	± 13.587
100 mg Inclisiran Sodium	7.51	± 17.455
200 mg Inclisiran Sodium	12.80	± 16.337
300 mg Inclisiran Sodium	11.68	± 18.486

Day 180

Group	Value	95% CI
Placebo	8.25	± 12.940
100 mg Inclisiran Sodium	6.89	± 17.051
200 mg Inclisiran Sodium	15.95	± 17.025
300 mg Inclisiran Sodium	14.26	± 20.158

Percent Change From Baseline in Non-HDL Cholesterol by Visit Secondary · Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180

Percent change from baseline in non-HDL Cholesterol by visit was calculated to evaluate the effect of inclisiran over time

Day 14

Group	Value	95% CI
Placebo	1.13	± 13.511
100 mg Inclisiran Sodium	-31.37	± 19.592
200 mg Inclisiran Sodium	-35.68	± 18.056
300 mg Inclisiran Sodium	-41.16	± 17.005

Day 30

Group	Value	95% CI
Placebo	1.03	± 11.483
100 mg Inclisiran Sodium	-44.72	± 16.270
200 mg Inclisiran Sodium	-47.99	± 15.318
300 mg Inclisiran Sodium	-54.17	± 12.815

Day 60

Group	Value	95% CI
Placebo	0.62	± 11.841
100 mg Inclisiran Sodium	-43.39	± 16.505
200 mg Inclisiran Sodium	-48.18	± 15.146
300 mg Inclisiran Sodium	-54.10	± 12.034

Day 90

Group	Value	95% CI
Placebo	1.75	± 11.931
100 mg Inclisiran Sodium	-39.83	± 16.485
200 mg Inclisiran Sodium	-47.20	± 15.002
300 mg Inclisiran Sodium	-53.18	± 13.236

Day 104

Group	Value	95% CI
Placebo	1.96	± 12.067
100 mg Inclisiran Sodium	-46.10	± 17.006
200 mg Inclisiran Sodium	-51.98	± 14.344
300 mg Inclisiran Sodium	-57.74	± 12.513

Day 120

Group	Value	95% CI
Placebo	0.82	± 14.045
100 mg Inclisiran Sodium	-48.22	± 17.301
200 mg Inclisiran Sodium	-53.52	± 15.425
300 mg Inclisiran Sodium	-58.67	± 12.175

Day 150

Group	Value	95% CI
Placebo	1.96	± 13.519
100 mg Inclisiran Sodium	-47.90	± 17.495
200 mg Inclisiran Sodium	-52.85	± 14.254
300 mg Inclisiran Sodium	-56.82	± 12.997

Day 180

Group	Value	95% CI
Placebo	1.29	± 13.455
100 mg Inclisiran Sodium	-44.83	± 15.558
200 mg Inclisiran Sodium	-50.15	± 16.446
300 mg Inclisiran Sodium	-54.04	± 14.230

Percent Change From Baseline in VLDL-C by Visit Secondary · Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180

Percent change from baseline in very low-density lipoprotein cholesterol (VLDL - C) by visit was calculated to evaluate the effect of inclisiran over time

Day 14

Group	Value	95% CI
Placebo	5.55	± 28.428
100 mg Inclisiran Sodium	-2.96	± 31.885
200 mg Inclisiran Sodium	-5.56	± 43.055
300 mg Inclisiran Sodium	-12.41	± 25.589

Day 30

Group	Value	95% CI
Placebo	6.69	± 33.655
100 mg Inclisiran Sodium	-9.01	± 28.560
200 mg Inclisiran Sodium	-13.39	± 28.081
300 mg Inclisiran Sodium	-14.74	± 30.582

Day 60

Group	Value	95% CI
Placebo	9.40	± 36.824
100 mg Inclisiran Sodium	-10.27	± 32.555
200 mg Inclisiran Sodium	-14.02	± 28.944
300 mg Inclisiran Sodium	-17.94	± 25.358

Day 90

Group	Value	95% CI
Placebo	6.53	± 33.387
100 mg Inclisiran Sodium	-5.39	± 41.490
200 mg Inclisiran Sodium	-16.70	± 26.127
300 mg Inclisiran Sodium	-15.76	± 27.957

Day 104

Group	Value	95% CI
Placebo	11.56	± 37.588
100 mg Inclisiran Sodium	-12.10	± 28.575
200 mg Inclisiran Sodium	-12.54	± 45.978
300 mg Inclisiran Sodium	-24.05	± 26.076

Day 120

Group	Value	95% CI
Placebo	3.10	± 33.707
100 mg Inclisiran Sodium	-15.90	± 30.271
200 mg Inclisiran Sodium	-14.05	± 36.083
300 mg Inclisiran Sodium	-22.29	± 24.030

Day 150

Group	Value	95% CI
Placebo	3.41	± 31.791
100 mg Inclisiran Sodium	-10.91	± 45.835
200 mg Inclisiran Sodium	-17.49	± 27.270
300 mg Inclisiran Sodium	-18.39	± 30.321

Day 180

Group	Value	95% CI
Placebo	-0.30	± 31.345
100 mg Inclisiran Sodium	-7.30	± 33.946
200 mg Inclisiran Sodium	-17.89	± 33.050
300 mg Inclisiran Sodium	-21.74	± 27.746

Percent Change From Baseline in Apo- A1 by Visit Secondary · Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180

Percent change from baseline in Apolipoprotein A1 (Apo-A1) by visit was calculated to evaluate the effect of inclisiran over time

Day 14

Group	Value	95% CI
Placebo	0.04	± 8.872
100 mg Inclisiran Sodium	3.64	± 9.293
200 mg Inclisiran Sodium	2.29	± 7.659
300 mg Inclisiran Sodium	3.98	± 7.952

Day 30

Group	Value	95% CI
Placebo	0.90	± 9.713
100 mg Inclisiran Sodium	2.70	± 10.553
200 mg Inclisiran Sodium	4.52	± 9.302
300 mg Inclisiran Sodium	4.35	± 9.012

Day 60

Group	Value	95% CI
Placebo	0.00	± 8.501
100 mg Inclisiran Sodium	4.71	± 11.785
200 mg Inclisiran Sodium	3.89	± 10.196
300 mg Inclisiran Sodium	5.18	± 10.023

Day 90

Group	Value	95% CI
Placebo	-0.35	± 9.888
100 mg Inclisiran Sodium	3.86	± 11.353
200 mg Inclisiran Sodium	5.71	± 10.609
300 mg Inclisiran Sodium	5.21	± 10.383

Day 104

Group	Value	95% CI
Placebo	0.14	± 10.780
100 mg Inclisiran Sodium	5.89	± 13.922
200 mg Inclisiran Sodium	5.66	± 11.007
300 mg Inclisiran Sodium	4.99	± 10.061

Day 120

Group	Value	95% CI
Placebo	1.79	± 10.707
100 mg Inclisiran Sodium	5.33	± 12.293
200 mg Inclisiran Sodium	6.49	± 11.334
300 mg Inclisiran Sodium	6.60	± 11.152

Day 150

Group	Value	95% CI
Placebo	3.70	± 11.571
100 mg Inclisiran Sodium	4.85	± 14.330
200 mg Inclisiran Sodium	7.46	± 11.582
300 mg Inclisiran Sodium	8.35	± 12.564

Day 180

Group	Value	95% CI
Placebo	6.09	± 11.862
100 mg Inclisiran Sodium	4.99	± 14.170
200 mg Inclisiran Sodium	10.26	± 12.250
300 mg Inclisiran Sodium	9.09	± 13.871

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 6/57 (11%)

Deaths: 1/57

Inclisiran 100 mg

Serious: 2/55 (4%)

Deaths: 0/55

Inclisiran 200 mg

Serious: 7/101 (7%)

Deaths: 0/101

Inclisiran 300 mg

Serious: 7/99 (7%)

Deaths: 0/99

Serious adverse events (24 terms)

Reaction	System	Placebo	Inclisiran 100 mg	Inclisiran 200 mg	Inclisiran 300 mg
Angina pectoris	Cardiac disorders	—	—	—	—
Angina unstable	Cardiac disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Ventricular extrasystoles	Cardiac disorders	—	—	—	—
Epiretinal membrane	Eye disorders	—	—	—	—
Vitreous haemorrhage	Eye disorders	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—
Death	General disorders	—	—	—	—
Vascular stent stenosis	General disorders	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—	—
Infection	Infections and infestations	—	—	—	—
Radius fracture	Injury, poisoning and procedural complications	—	—	—	—
Toxicity to various agents	Injury, poisoning and procedural complications	—	—	—	—
Wound dehiscence	Injury, poisoning and procedural complications	—	—	—	—
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	—	—	—	—
Electrolyte imbalance	Metabolism and nutrition disorders	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—
Fracture pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Embolic cerebral infarction	Nervous system disorders	—	—	—	—
Peripheral artery occlusion	Vascular disorders	—	—	—	—

Other adverse events (18 terms — click to expand)

Reaction	System	Placebo	Inclisiran 100 mg	Inclisiran 200 mg	Inclisiran 300 mg
Pyrexia	General disorders	—	—	—	—
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	—	—	—	—
Injection site reaction	General disorders	—	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—
Vaccination site pain	General disorders	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Malaise	General disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—
C-reactive protein increased	Investigations	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—

Most-reported serious reactions: Angina pectoris, Angina unstable, Cardiac failure congestive, Ventricular extrasystoles, Epiretinal membrane, Vitreous haemorrhage, Pancreatitis acute, Death.

Data from ClinicalTrials.gov NCT04666298 adverse events section.

Sponsor's own description

This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Inclisiran: First Approval.
Lamb YN. · · 2021 · cited 257× · PMID 33620677 · DOI 10.1007/s40265-021-01473-6
Therapeutic siRNA: State-of-the-Art and Future Perspectives.
Friedrich M, Aigner A. · · 2022 · cited 256× · PMID 35997897 · DOI 10.1007/s40259-022-00549-3
Targeting proprotein convertase subtilisin/kexin type 9 (PCSK9): from bench to bedside.
Bao X, Liang Y, Chang H, Cai T, et al · · 2024 · cited 101× · PMID 38185721 · DOI 10.1038/s41392-023-01690-3
RNA therapeutics in the clinic.
Curreri A, Sankholkar D, Mitragotri S, Zhao Z. · · 2023 · cited 62× · PMID 36684099 · DOI 10.1002/btm2.10374
Clinical potential of inclisiran for patients with a high risk of atherosclerotic cardiovascular disease.
Nishikido T. · · 2023 · cited 28× · PMID 36717882 · DOI 10.1186/s12933-023-01752-4
RNA Silencing in the Management of Dyslipidemias.
Henney NC, Banach M, Penson PE. · · 2021 · cited 23× · PMID 34468873 · DOI 10.1007/s11883-021-00968-7
Nucleic acid therapeutics: Past, present, and future.
Naeem S, Zhang J, Zhang Y, Wang Y. · · 2025 · cited 21× · PMID 39897578 · DOI 10.1016/j.omtn.2024.102440
Development of Novel siRNA Therapeutics: A Review with a Focus on Inclisiran for the Treatment of Hypercholesterolemia.
Ebenezer O, Comoglio P, Wong GK, Tuszynski JA. · · 2023 · cited 21× · PMID 36835426 · DOI 10.3390/ijms24044019

Verify or expand the search:

Other trials of Inclisiran sodium

Trials testing the same drug.

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Currently open trials in the same condition.

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Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04666298 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 20 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04666298.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04666298: ORION-15

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (24 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Inclisiran sodium

Other recruiting trials for Hypercholesterolemia

Other Novartis Pharmaceuticals trials

Verify against primary sources