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
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 4 Dec 2024
- Start date
- 13 Feb 2025
- Primary completion date
- 25 Aug 2025
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06723652
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 55
- From 13 Feb 2025 to the primary completion date, 25 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening
Lab values
- 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
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Xiangya Hospital of Central South University Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.