Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06009393
Collaborator
(none)
20
1
10.8
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Anticipated Study Start Date
:
Sep 24, 2023
Anticipated Primary Completion Date
:
Jun 23, 2024
Anticipated Study Completion Date
:
Aug 18, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SHR-1918
|
Drug: SHR-1918
Three administration
|
Outcome Measures
Primary Outcome Measures
- Percent change in calculated LDL-C from baseline to week 12 [from baseline to week 12]
Secondary Outcome Measures
- Change in calculated LDL-C from baseline to week 12 [from baseline to week 12]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Beijing Suncadia Pharmaceuticals Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Beijing Suncadia Pharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier:
NCT06009393
Other Study ID Numbers:
- SHR-1918-202
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: