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

NCT06723652 | Completed Phase 3

• 1 other identifier: SHR-1918-301
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Homozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

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

  week 12

Secondary Outcomes (2)

• 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

Study Arms (2)

SHR-1918

EXPERIMENTAL

Drug: SHR-1918

SHR-1918 placebo

PLACEBO COMPARATOR

Drug: SHR-1918 placebo

Interventions

SHR-1918 DRUG

six administration

SHR-1918

SHR-1918 placebo DRUG

SHR-1918 placebo three administration+SHR-1918 three administration

SHR-1918 placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University Hospital

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Homozygous Familial Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipoproteinemia Type II; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: February 13, 2025
• Primary Completion: August 25, 2025
• Study Completion: November 18, 2025
• Last Updated: December 15, 2025

Record last verified: 2024-12

Locations

CN (1)