A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

Last updated: March 18, 2025
Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Hypercholesterolemia

Familial Hypercholesterolemia

Treatment

SHR-1918

SHR-1918 placebo

Clinical Study ID

NCT06723652
SHR-1918-301
  • Ages > 12
  • All Genders

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined inthe protocol

  2. LDL-C ≥2.6mmol/L at the screening visit

  3. Body weight ≥40 kg

  4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment.

Exclusion

Exclusion Criteria:

  1. Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening

  2. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes atscreening (HbA1c > 8.5%)

  3. eGFR <30ml/min/1.73m2 at the screening visit

  4. CK >5times ULN at the screening visit

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: SHR-1918
Phase: 3
Study Start date:
February 13, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • The Second Xiangya Hospital of Central South University Hospital

    Changsha, Hunan 410000
    China

    Active - Recruiting

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