NCT05399992

Brief Summary

This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
847

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
8 countries

40 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2022Oct 2026

First Submitted

Initial submission to the registry

May 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2026

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

May 27, 2022

Last Update Submit

January 30, 2026

Conditions

Primary HypercholesterolemiaMixed Dyslipidemia

Keywords

primary hypercholesterolemiamixed dyslipidemiareal-world studyinclisiranlipid-lowering therapyLLTASCVD

Outcome Measures

Primary Outcomes (1)

  • Percentage change in LDL-C from baseline to 10 months

    Percentage change in Low density lipoprotein - Cholesterol (LDL-C)

    Baseline, 10 months

Secondary Outcomes (18)

  • Percentage change in LDL-C from baseline

    Baseline, month 4, month 16, month 22

  • Percentage change in LDL-C from baseline by ≥50%

    Month 4, month 10, month 16, month 22

  • Percentage change in LDL-C from baseline by ≥30%

    Month 4, month 10, month 16, month 22

  • Proportion of participants achieving LDL-C<55 mg/dL

    Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22

  • Proportion of participants achieving LDL-C<70 mg/dL

    Month 4, month 10, month 16 and month 22

  • +13 more secondary outcomes

Study Arms (1)

Inclisiran cohort

Participants prescribed inclisiran alone or with other LLTs as per approved label

Other: Inclisiran

Interventions

InclisiranOTHER

Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study.

Inclisiran cohort

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult participants with an underlying diagnosis of Atherosclerotic Cardiovascular Disease (ASCVD), ASCVD risk equivalent (ASCVD RE), or Heterozygous familial hypercholesterolemia (HeFH) and elevated levels of Low density lipoprotein - Cholesterol (LDL-C)

You may qualify if:

  • Participants who are 18 years or older
  • Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
  • Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
  • Participants who per physician's criteria need to optimize their LLT
  • Participants who provide written informed consent to participate in the study
  • Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.

You may not qualify if:

  • Participants that have received inclisiran previously
  • Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Novartis Investigative Site

Feldkirch, 6807, Austria

Location

Novartis Investigative Site

Graz, 8036, Austria

Location

Novartis Investigative Site

Linz, 4021, Austria

Location

Novartis Investigative Site

Sankt Veit im Pongau, 5621, Austria

Location

Novartis Investigative Site

Vienna, 1090, Austria

Location

Novartis Investigative Site

Vienna, 1180, Austria

Location

Novartis Investigative Site

Shenzhen, Guangdong, 518000, China

Location

Novartis Investigative Site

Holon, Gush Dan, 5845997, Israel

Location

Novartis Investigative Site

Petah Tikva, 4941492, Israel

Location

Novartis Investigative Site

Tel Aviv, 6801296, Israel

Location

Novartis Investigative Site

Kuala Lumpur, Kuala Lumpur, 50470, Malaysia

Location

Novartis Investigative Site

Kuala Lumpur, 50400, Malaysia

Location

Novartis Investigative Site

Riyadh, Saudi, 11643, Saudi Arabia

Location

Novartis Investigative Site

Jeddah, 23311, Saudi Arabia

Location

Novartis Investigative Site

Tabuk, 47512, Saudi Arabia

Location

Novartis Investigative Site

Fribourg, CH, 1708, Switzerland

Location

Novartis Investigative Site

Basel, 4031, Switzerland

Location

Novartis Investigative Site

Geneva, 1211, Switzerland

Location

Novartis Investigative Site

Lausanne, 1011, Switzerland

Location

Novartis Investigative Site

Olten, 4600, Switzerland

Location

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

Location

Novartis Investigative Site

Zurich, 8032, Switzerland

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Abu Dhabi, Abu Dhabi Emirate, 00000, United Arab Emirates

Location

Novartis Investigative Site

Dubai, United Arab Emirates, 7272, United Arab Emirates

Location

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

Location

Novartis Investigative Site

Al Ain City, United Arab Emirates

Location

Novartis Investigative Site

Dubai, United Arab Emirates

Location

Novartis Investigative Site

High Wycombe, Buckinghamshire, HP11 2TR, United Kingdom

Location

Novartis Investigative Site

Louth, Lincolnshire, LN11 7QU, United Kingdom

Location

Novartis Investigative Site

Sunderland, Tyne and Wear, SR4 7TP, United Kingdom

Location

Novartis Investigative Site

Belfast, BT16 1RH, United Kingdom

Location

Novartis Investigative Site

Bromwich, B71 4HJ, United Kingdom

Location

Novartis Investigative Site

Burton-on-Trent, DE13 0RB, United Kingdom

Location

Novartis Investigative Site

Cardiff, CF14 4XW, United Kingdom

Location

Novartis Investigative Site

Hull, HU3 2RW, United Kingdom

Location

Novartis Investigative Site

Lancaster, LA1 4RP, United Kingdom

Location

Novartis Investigative Site

Liverpool, L7 8XP, United Kingdom

Location

Novartis Investigative Site

London, NW3 2QG, United Kingdom

Location

Novartis Investigative Site

Middlesex, UB9 6JH, United Kingdom

Location

MeSH Terms

Interventions

ALN-PCS

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 1, 2022

Study Start

September 12, 2022

Primary Completion (Estimated)

October 5, 2026

Study Completion (Estimated)

October 5, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

MY(2)CN(1)GB(12)CH(8)SA(3)AU(6)IL(3)AE(5)