NCT06009393CompletedPhase 2
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
A Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
This is a single-arm, open-label 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 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 15 Aug 2023
- Start date
- 22 Dec 2023
- Primary completion date
- 29 Jun 2024
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06009393
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 26
- From 22 Dec 2023 to the primary completion date, 29 Jun 2024
- 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.
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: 18 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 |
Related publications
- Anti-ANGPTL3 Antibody SHR-1918 for Homozygous Familial Hypercholesterolemia: A Nonrandomized Clinical Trial.JAMA Cardiol · 2026 · PMID 41499141
This page is information, not medical advice. Discuss any trial with your doctor.