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Clinical Trials/NCT06723652
NCT06723652CompletedPhase 3

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

Beijing Suncadia Pharmaceuticals Co., Ltd1 site in 1 country55 target enrollmentStarted: February 13, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
55
Locations
1
Primary Endpoint
Percent change in calculated LDL-C from baseline to week 12

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening
  • 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

Arms & Interventions

SHR-1918

Experimental

Intervention: SHR-1918 (Drug)

SHR-1918 placebo

Placebo Comparator

Intervention: SHR-1918 placebo (Drug)

Outcomes

Primary Outcomes

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

Time Frame: week 12

Secondary Outcomes

  • Change in calculated LDL-C from baseline to week 12(week 12)
  • Percent change and changer in calculated LDL-C from baseline to week 24(week 24)

Investigators

Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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