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

Launched by BEIJING SUNCADIA PHARMACEUTICALS CO., LTD · Dec 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-1918 for patients with a rare genetic condition known as homozygous familial hypercholesterolemia (HoFH), which causes very high levels of bad cholesterol (LDL-C) in the blood. The goal of the study is to see if SHR-1918 can effectively lower these cholesterol levels. This is a Phase III trial, meaning it’s one of the final steps before the treatment can be approved for general use.

To be eligible for this trial, participants must have a confirmed diagnosis of HoFH, with cholesterol levels above a certain point, and must weigh at least 40 kilograms. They should also have been on stable cholesterol-lowering medications for at least 28 days before joining. Participants will be randomly assigned to receive either SHR-1918 or a placebo (a harmless look-alike treatment with no active medicine) without knowing which one they are getting. Throughout the trial, they will be monitored for any side effects and how well the treatment works. This study is currently recruiting patients of all genders aged 18 and older, and it’s an important step in finding new ways to help those with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the 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 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 at screening (HbA1c \> 8.5%)
• • 3. eGFR \<30ml/min/1.73m2 at the screening visit
• • 4. CK \>5times ULN at the screening visit