Evaluating SHR-1918 for lowering cholesterol in patients with a genetic condition
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
This study is testing if a new drug called SHR-1918 can lower cholesterol levels in people with a genetic condition that causes very high cholesterol.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Beijing Suncadia Pharmaceuticals Co., Ltd Industry-sponsored |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06723652 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled phase III clinical study aims to evaluate the efficacy and safety of SHR-1918 in reducing low-density lipoprotein cholesterol (LDL-C) in patients diagnosed with homozygous familial hypercholesterolemia (HoFH). Participants will be randomly assigned to receive either SHR-1918 or a placebo while being on stable lipid-lowering therapy. The study will assess the changes in LDL-C levels over a specified period to determine the effectiveness of the treatment. The trial is designed to ensure rigorous scientific evaluation through its controlled methodology.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with functional homozygous familial hypercholesterolemia who have elevated LDL-C levels and are on stable lipid-lowering therapy.
Not a fit: Patients with poorly controlled diabetes, severe kidney impairment, or those who have recently used specific cholesterol-lowering treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly lower cholesterol levels in patients with a genetic predisposition to high cholesterol, improving their overall health outcomes.
How similar studies have performed: Other studies targeting similar conditions have shown promise, but the specific approach with SHR-1918 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changsha, Hunan
- The Second Xiangya Hospital of Central South University Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Sun Meng
- Email: meng.sun@hengrui.com
- Phone: +86 18036618718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.