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

Launched by BEIJING SUNCADIA PHARMACEUTICALS CO., LTD · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SHR-1918 to see how well it can lower a type of bad cholesterol known as LDL-C in patients with a condition called homozygous familial hypercholesterolemia (HoFH). HoFH is a genetic disorder that makes it very difficult for people to lower their cholesterol levels, even with medications. The trial is in its second phase and aims to understand the effectiveness and safety of SHR-1918 in helping these patients manage their cholesterol.

To participate in this trial, individuals must have a confirmed diagnosis of HoFH and have a certain level of LDL-C in their blood. They should also weigh at least 40 kg and have been on stable cholesterol-lowering medication for at least 28 days before joining. However, people with other serious health issues, like certain types of diabetes or kidney problems, may not be eligible. If someone joins the study, they will receive SHR-1918 and be monitored to see how well it works for them. It's important to note that the trial is not yet recruiting participants, so there will be more details available soon for those interested.

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. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%)
• • 2. eGFR \<30ml/min/1.73m2 at the screening visit
• • 3. CK \>5times ULN at the screening visit