Trial · NCT03400800

Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol

NCT03400800, Phase 3, Completed, The Medicines Company; results first posted 2020-08-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol. Trials, record NCT03400800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03400800

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
NCT number: NCT03400800
Status: Completed
Phases: Phase 3
Enrollment: 1,617 participants, actual
Lead sponsor: The Medicines Company
Conditions: ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
Interventions: Inclisiran Sodium, Placebo
First posted: 2018-01-17
Last updated: 2020-08-21
Results first posted: 2020-08-21

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Percentage Change in LDL-C From Baseline to Day 510	Baseline, Day 510
Primary	Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540	Baseline, Day 90 to Day 540
Secondary	Absolute Change In LDL-C From Baseline To Day 510	Baseline, Day 510
Secondary	Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540	Baseline, Day 90 to Day 540
Secondary	Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510	Baseline, Day 510
Secondary	Percentage Change in Total Cholesterol From Baseline to Day 510	Baseline, Day 510
Secondary	Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510	Baseline, Day 510
Secondary	Percentage Change in Non-HDL-C From Baseline to Day 510	Baseline, Day 510

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage Change in LDL-C From Baseline to Day 510	Baseline, Day 510	ITT population	Percent change	LEAST_SQUARES_MEAN
PRIMARY	Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540	Baseline, Day 90 to Day 540	ITT population	Percent change	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change In LDL-C From Baseline To Day 510	Baseline, Day 510		mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540	Baseline, Day 90 to Day 540		mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510	Baseline, Day 510		Percent change	LEAST_SQUARES_MEAN
SECONDARY	Percentage Change in Total Cholesterol From Baseline to Day 510	Baseline, Day 510	ITT Population	Percent change	LEAST_SQUARES_MEAN
SECONDARY	Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510	Baseline, Day 510	ITT Population	Percent change	LEAST_SQUARES_MEAN
SECONDARY	Percentage Change in Non-HDL-C From Baseline to Day 510	Baseline, Day 510	ITT Population	Percent change	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage Change in LDL-C From Baseline to Day 510	Inclisiran	-49.3	95% Confidence Interval -51.22 to -47.48	Percent change
Percentage Change in LDL-C From Baseline to Day 510	Placebo	4.2	95% Confidence Interval 1.62 to 6.69	Percent change
Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540	Inclisiran	-45.82	95% Confidence Interval -47.52 to -44.13	Percent change
Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540	Placebo	3.35	95% Confidence Interval 1.65 to 5.05	Percent change
Absolute Change In LDL-C From Baseline To Day 510	Inclisiran	-50.91	95% Confidence Interval -53.14 to -48.67	mg/dL
Absolute Change In LDL-C From Baseline To Day 510	Placebo	0.96	95% Confidence Interval -1.26 to 3.18	mg/dL
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540	Inclisiran	-48.63	95% Confidence Interval -50.37 to -46.89	mg/dL
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540	Placebo	0.31	95% Confidence Interval -1.42 to 2.04	mg/dL
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510	Inclisiran	-63.64	95% Confidence Interval -65.55 to -61.74	Percent change
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510	Placebo	15.62	95% Confidence Interval 13.72 to 17.53	Percent change

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Inclisiran	810
Overall Study	STARTED	Placebo	807
Overall Study	COMPLETED	Inclisiran	772
Overall Study	COMPLETED	Placebo	770
Overall Study	NOT COMPLETED	Inclisiran	38
Overall Study	NOT COMPLETED	Placebo	37

Source ClinicalTrials.gov

Adverse events542

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Inclisiran	91	811
other	Nasopharyngitis	Infections and infestations	Placebo	90	804
other	Upper respiratory tract infection	Infections and infestations	Inclisiran	52	811
other	Upper respiratory tract infection	Infections and infestations	Placebo	49	804
other	Diabetes mellitus	Metabolism and nutrition disorders	Inclisiran	88	811
other	Diabetes mellitus	Metabolism and nutrition disorders	Placebo	94	804
other	Arthralgia	Musculoskeletal and connective tissue disorders	Inclisiran	47	811
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	32	804
other	Hypertension	Vascular disorders	Inclisiran	53	811
other	Hypertension	Vascular disorders	Placebo	54	804

1 to 10 of 542Source ClinicalTrials.gov

See all 542 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Inclisiran	14	811
Total, all-cause mortality	Placebo	15	804
Total, other adverse events	Inclisiran	331	811
Total, other adverse events	Placebo	319	804
Total, serious adverse events	Inclisiran	181	811
Total, serious adverse events	Placebo	181	804

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32187462	DERIVED	PubMed
37282500	DERIVED	PubMed
38063346	DERIVED	PubMed
38757725	DERIVED	PubMed
39093262	DERIVED	PubMed
41604274	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Inclisiran vs Placebo: deaths from any cause	Trial comparisons
Inclisiran vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03400800

GET https://conductscience.org/api/trials/v1/NCT03400800/events?page=2

API reference For AI assistants