Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies

Last updated: March 18, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Hypercholesterolemia

Familial Hypercholesterolemia

Treatment

Inclisiran

Clinical Study ID

NCT05682378
CKJX839C12001B
2022-002316-23
  • Ages 12-100
  • All Genders

Study Summary

The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies.

Eligibility Criteria

Inclusion

Key inclusion:

  • Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16 or ORION-13 studies

  • Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies

Key exclusion:

  • Participants who in the feeder inclisiran ORION-16 and ORION-13 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment

  • Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk

Study Design

Total Participants: 154
Treatment Group(s): 1
Primary Treatment: Inclisiran
Phase: 3
Study Start date:
February 10, 2023
Estimated Completion Date:
March 02, 2028

Study Description

This is an open-label, single arm, multicenter study designed to evaluate long-term safety and tolerability of inclisiran. In addition, the study will provide participants the opportunity to have continued access to treatment with inclisiran.

Connect with a study center

  • Novartis Investigative Site

    Ciudad de Formosa, Formosa P3600
    Argentina

    Completed

  • Novartis Investigative Site

    Fortaleza, Ceara 60430275
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Paulo, SP 05403 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Quebec, G1V 4W2
    Canada

    Site Not Available

  • Novartis Investigative Site

    Praha, 12808
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Praha 5, 150 06
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Besancon Cedex, 25030
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse Cedex, 31059
    France

    Site Not Available

  • Novartis Investigative Site

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Freiburg, 79100
    Germany

    Site Not Available

  • Novartis Investigative Site

    Athens, 115 27
    Greece

    Site Not Available

  • Novartis Investigative Site

    Pecs, 7623
    Hungary

    Completed

  • Novartis Investigative Site

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Milano, MI 20162
    Italy

    Completed

  • Novartis Investigative Site

    Modena, MO 41124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma, RM 00165
    Italy

    Site Not Available

  • Novartis Investigative Site

    Irbid, 22110
    Jordan

    Active - Recruiting

  • Novartis Investigative Site

    Ashrafieh, 166830
    Lebanon

    Active - Recruiting

  • Novartis Investigative Site

    Sungai Buloh, Selangor Darul Ehsan 47000
    Malaysia

    Site Not Available

  • Novartis Investigative Site

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Novartis Investigative Site

    Rotterdam, Zuid Holland 3015 GD
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Oslo, 0514
    Norway

    Active - Recruiting

  • Novartis Investigative Site

    Gdansk, 80 952
    Poland

    Site Not Available

  • Novartis Investigative Site

    Lodz, 93-338
    Poland

    Site Not Available

  • Novartis Investigative Site

    Kemerovo, 650002
    Russian Federation

    Completed

  • Novartis Investigative Site

    Moscow, 127412
    Russian Federation

    Completed

  • Novartis Investigative Site

    Poprad, 058 01
    Slovakia

    Active - Recruiting

  • Novartis Investigative Site

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

  • Novartis Investigative Site

    Bloemfontein, Free State 9301
    South Africa

    Active - Recruiting

  • Novartis Investigative Site

    Cape Town, Western Cape 7130
    South Africa

    Active - Recruiting

  • Novartis Investigative Site

    Cordoba, Andalucia 14004
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Novartis Investigative Site

    A Coruna, 15001
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Geneve 14, 1211
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Taipei, 103616
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Istanbul, TUR 34098
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Adana, 01330
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Ankara, 06500
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Izmir, 35100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Middlesex, UB9 6JH
    United Kingdom

    Site Not Available

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Icahn School of Med at Mt Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Icahn School of Med at Mt Sinai .

    New York, New York 10029
    United States

    Site Not Available

  • Novartis Investigative Site

    New York, New York 10029
    United States

    Active - Recruiting

  • Cincinnati Childrens Hospital MC

    Cincinnati, Ohio 45229-3039
    United States

    Active - Recruiting

  • Cincinnati Childrens Hospital MC .

    Cincinnati, Ohio 45229-3039
    United States

    Active - Recruiting

  • Childrens Hosp Pittsburgh UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Primary Childrens Medical Center

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Primary Childrens Medical Center Research

    Salt Lake City, Utah 84113
    United States

    Site Not Available

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