Trial · NCT02597127

Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)

NCT02597127, Phase 2, Completed, The Medicines Company; results first posted 2019-05-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C). Trials, record NCT02597127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02597127

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Trial

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

Title: Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)
NCT number: NCT02597127
Status: Completed
Phases: Phase 2
Enrollment: 501 participants, actual
Lead sponsor: The Medicines Company
Conditions: Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia, Diabetes
Interventions: ALN-PCSSC, Normal Saline
First posted: 2015-11-05
Last updated: 2019-05-17
Results first posted: 2019-05-17

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Percentage Change in LDL-C From Baseline to Day 180	Baseline to 180 days	Percent Change in LDL-C (beta-quantification) from Baseline to Day 180 in MITT Population
Secondary	Percentage Change in LDL-C From Baseline to Day 90	Baseline to 90 days	Percent Change in LDL-C (beta-quantification) from Baseline to Day 90 in MITT Population
Secondary	Percent Change From Baseline In LDL-C Levels At Day 60, Day 120, and Day 210	Baseline, Day 60, Day 120, and Day 210	This outcome measure evaluated the effects of both single- and double-dose inclisiran on LDL-C levels in the mITT population from baseline to Day 60, Day 120, and Day 210.
Secondary	Number of Participants With an LDL-C Greater Than 80% of the Baseline Value at Day 180 and Day 210	Baseline, Day 180, Day 210	This outcome measure evaluated the number of participants (single and double dose) in the mITT population with an LDL-C greater than 80% of the baseline value at Day 180 and Day 210.
Secondary	Number of Participants With Individual Responsiveness as Measured By LDL-C Levels at Day 90 and Day 180	Day 90, Day 180	This outcome measure evaluated the individual responsiveness of participants to inclisiran (single and double dose) in the mITT population as defined by an LDL-C level of \<25 mg/deciliter \[dL\] at Day 90 and Day 180.
Secondary	Number of Participants With Greater Or Equal To 50% LDL-C Reduction From Baseline At Day 180	Baseline, Day 180	This outcome measure evaluated the number of participants (single and double dose) in the mITT population with an LDL-C reduction greater than 50% of the baseline value at Day 180.
Secondary	Percentage Change in PCSK9 Levels From Baseline at Day 180	Baseline, Day 180	This outcome measure evaluated the percent change in proprotein convertase subtilisin/kexin type 9 (PCSK9) from baseline to Day 180 in participants (single and double dose) in the mITT population.
Secondary	Percentage Change in Other Lipids and Apolipoproteins From Baseline to Day 180	Baseline, Day 180	This outcome measure evaluated the percent change from baseline to Day 180 in cholesterol (total, high-density lipoprotein \[HDL\], non-HDL) and apolipoproteins (B, A1) in participants (single and double dose) in the mITT population.
Secondary	Number of Participants Who Attained Global Lipid Modification Targets for Level of Atherosclerotic Cardiovascular Disease Risk	Baseline, Day 180	This outcome measure evaluated the proportion of participants (single and double dose) in the mITT population who attained a global lipid modification target by baseline cardiovascular risk group, looking specifically at LDL-C levels (mg/dL) in the category of cardiovascular disease (CVD). CVD was defined as a participant who had at least 1 of the following: prior myocardial infarction, prior percutaneous coronary intervention, prior coronary artery bypass graft, prior stroke, prior transient ischemic attack, peripheral artery disease.
Secondary	Percentage Change in Other Lipids and Inflammatory Markers From Baseline to Day 180	Baseline, Day 180	This outcome measure evaluated the percent change from baseline to Day 180 in triglycerides, very-low-density lipoprotein (VLDL) cholesterol, lipoprotein(a), and high sensitivity C-reactive protein (hsCRP) in participants (single and double dose) in the mITT population.

Source ClinicalTrials.gov

Outcomes10

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 180	Baseline to 180 days	Modified intent-to-treat (MITT) population	Percent change	LEAST_SQUARES_MEAN
SECONDARY	Percentage Change in LDL-C From Baseline to Day 90	Baseline to 90 days	In this analysis, the single and double-dose 200mg arms were combined, as were the single and double-dose 300mg arms. The second dose for patients in double-dose arms was given on Day 90. Therefore, up to day 90, those patients in double-dose arms received the same treatment as patients in the single dose arms within the same dose amount.	Percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline In LDL-C Levels At Day 60, Day 120, and Day 210	Baseline, Day 60, Day 120, and Day 210		Percent change	MEAN
SECONDARY	Number of Participants With an LDL-C Greater Than 80% of the Baseline Value at Day 180 and Day 210	Baseline, Day 180, Day 210		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Individual Responsiveness as Measured By LDL-C Levels at Day 90 and Day 180	Day 90, Day 180		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Greater Or Equal To 50% LDL-C Reduction From Baseline At Day 180	Baseline, Day 180		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage Change in PCSK9 Levels From Baseline at Day 180	Baseline, Day 180		percent change	MEAN
SECONDARY	Percentage Change in Other Lipids and Apolipoproteins From Baseline to Day 180	Baseline, Day 180		percent change	MEAN
SECONDARY	Number of Participants Who Attained Global Lipid Modification Targets for Level of Atherosclerotic Cardiovascular Disease Risk	Baseline, Day 180		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage Change in Other Lipids and Inflammatory Markers From Baseline to Day 180	Baseline, Day 180		percent change	MEDIAN

Source ClinicalTrials.gov

Results by group173

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 180	Placebo (Single Dose)	2.1	95% Confidence Interval -2.9 to 7.2	Percent change
Percentage Change in LDL-C From Baseline to Day 180	200 mg (Single Dose)	-27.9	95% Confidence Interval -33.1 to -22.7	Percent change
Percentage Change in LDL-C From Baseline to Day 180	300 mg (Single Dose)	-38.4	95% Confidence Interval -43.6 to -33.2	Percent change
Percentage Change in LDL-C From Baseline to Day 180	500 mg (Single Dose)	-41.9	95% Confidence Interval -47.2 to -36.7	Percent change
Percentage Change in LDL-C From Baseline to Day 180	Placebo (Double Dose)	1.8	95% Confidence Interval -2.6 to 6.3	Percent change
Percentage Change in LDL-C From Baseline to Day 180	100 mg (Double Dose)	-35.5	95% Confidence Interval -40.0 to -31.0	Percent change
Percentage Change in LDL-C From Baseline to Day 180	200 mg (Double Dose)	-44.9	95% Confidence Interval -49.3 to -40.4	Percent change
Percentage Change in LDL-C From Baseline to Day 180	300 mg (Double Dose)	-52.6	95% Confidence Interval -57.1 to -48.1	Percent change
Percentage Change in LDL-C From Baseline to Day 90	Single Dose 500 mg	-49	95% Confidence Interval -53.8 to -44.2	Percent change
Percentage Change in LDL-C From Baseline to Day 90	Double Dose 100 mg	-34.2	95% Confidence Interval -39.1 to -29.3	Percent change

1 to 10 of 173Source ClinicalTrials.gov

See all 173 results by group

Participant flow32

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Inclisiran 200 mg (Single-dose)	60
Overall Study	STARTED	Inclisiran 300 mg (Single-dose)	62
Overall Study	STARTED	Inclisiran 500 mg (Single-dose)	66
Overall Study	STARTED	Placebo (Single-dose)	65
Overall Study	STARTED	Inclisiran 100 mg (Double-dose)	62
Overall Study	STARTED	Inclisiran 200 mg (Double-dose)	63
Overall Study	STARTED	Inclisiran 300 mg (Double-dose)	61
Overall Study	STARTED	Placebo (Double-dose)	62
Overall Study	Treated	Inclisiran 200 mg (Single-dose)	60
Overall Study	Treated	Inclisiran 300 mg (Single-dose)	61

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events904

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	Angina pectoris	Cardiac disorders	Placebo (Single Dose)	1	65
other	Angina pectoris	Cardiac disorders	Inclisiran 200 mg (Single Dose)	2	60
other	Angina pectoris	Cardiac disorders	Inclisiran 300 mg (Single Dose)	4	61
other	Angina pectoris	Cardiac disorders	Inclisiran 500 mg (Single Dose)	1	65
other	Angina pectoris	Cardiac disorders	Placebo (Double Dose)	2	62
other	Angina pectoris	Cardiac disorders	Inclisiran 100 mg (Double Dose)	0	61
other	Angina pectoris	Cardiac disorders	Inclisiran 200 mg (Double Dose)	2	62
other	Angina pectoris	Cardiac disorders	Inclisiran 300 mg (Double Dose)	0	61
other	Abdominal pain	Gastrointestinal disorders	Placebo (Single Dose)	2	65
other	Abdominal pain	Gastrointestinal disorders	Inclisiran 200 mg (Single Dose)	3	60

1 to 10 of 904Source ClinicalTrials.gov

See all 904 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo (Single Dose)	0	65
Total, all-cause mortality	Inclisiran 200 mg (Single Dose)	0	60
Total, all-cause mortality	Inclisiran 300 mg (Single Dose)	0	61
Total, all-cause mortality	Inclisiran 500 mg (Single Dose)	1	65
Total, all-cause mortality	Placebo (Double Dose)	0	62
Total, all-cause mortality	Inclisiran 100 mg (Double Dose)	0	61
Total, all-cause mortality	Inclisiran 200 mg (Double Dose)	1	62
Total, all-cause mortality	Inclisiran 300 mg (Double Dose)	0	61
Total, other adverse events	Placebo (Single Dose)	50	65
Total, other adverse events	Inclisiran 200 mg (Single Dose)	49	60

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers39

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
4609051	BACKGROUND	PubMed
11373684	BACKGROUND	PubMed
12730697	BACKGROUND	PubMed
12842255	BACKGROUND	PubMed
15249516	BACKGROUND	PubMed
15364185	BACKGROUND	PubMed
15538359	BACKGROUND	PubMed
16041363	BACKGROUND	PubMed
16098311	BACKGROUND	PubMed
16343994	BACKGROUND	PubMed

1 to 10 of 39

See all 39 papers

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 comparisons0

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

None in this release.

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/NCT02597127

GET https://conductscience.org/api/trials/v1/NCT02597127/results?page=2

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