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Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

Primary Purpose

Homozygous Familial Hypercholesterolemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1918
Sponsored by
Beijing Suncadia Pharmaceuticals Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Homozygous Familial Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol LDL-C ≥2.6mmol/L at the screening visit Body weight ≥40 kg Receiving stable lipid-lowering therapy for at least 28 days before enrollment. Exclusion Criteria: Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%) eGFR <30ml/min/1.73m2 at the screening visit CK >5times ULN at the screening visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SHR-1918

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percent change in calculated LDL-C from baseline to week 12

    Secondary Outcome Measures

    Change in calculated LDL-C from baseline to week 12

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    August 22, 2023
    Sponsor
    Beijing Suncadia Pharmaceuticals Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06009393
    Brief Title
    Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
    Official Title
    A Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 24, 2023 (Anticipated)
    Primary Completion Date
    June 23, 2024 (Anticipated)
    Study Completion Date
    August 18, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Suncadia Pharmaceuticals Co., Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a single-arm, open-label study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Homozygous Familial Hypercholesterolemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SHR-1918
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1918
    Intervention Description
    Three administration
    Primary Outcome Measure Information:
    Title
    Percent change in calculated LDL-C from baseline to week 12
    Time Frame
    from baseline to week 12
    Secondary Outcome Measure Information:
    Title
    Change in calculated LDL-C from baseline to week 12
    Time Frame
    from baseline to week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol LDL-C ≥2.6mmol/L at the screening visit Body weight ≥40 kg Receiving stable lipid-lowering therapy for at least 28 days before enrollment. Exclusion Criteria: Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%) eGFR <30ml/min/1.73m2 at the screening visit CK >5times ULN at the screening visit
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meng Sun
    Phone
    +86 18036618718
    Email
    meng.sun@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

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