Familial HypercholesterolemiaPhase 2NCT04455581
A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia
A Phase 2 study testing SHR-1209 in people with Familial Hypercholesterolemia, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for at least 28 days, to receive subcutaneous… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- SHR-1209
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age
- Diagnosis of homozygous familial hypercholesterolemia
- Stable lipid-lowering therapies for at least 28 days
- LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
- Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
- Bodyweight of ≥ 40 kg at screening.
Who cannot join
- LDL or plasma apheresis within 8 weeks prior to randomization
- New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
- Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months of randomization, Planned cardiac surgery or revascularization, Uncontrolled cardiac arrhythmia
- Liver transplant history.
- Uncontrolled hypertension.
- Moderate to severe renal dysfunction.
- Active liver disease or hepatic dysfunction.
- Known sensitivity to any of the products to be administered during dosing
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Open-label, Single-arm, Multicentre Study to Evaluate Efficacy and Safety of SHR-1209 in Subjects With Homozygous Familial Hypercholesterolemia
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for at least 28 days, to receive subcutaneous SHR-1209, follow up 8 weeks. The primary endpoint was percentage change in LDL cholesterol from baseline at week 12 .
- Conditions
- Familial Hypercholesterolemia
- Being tested
- SHR-1209
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1209Drug
SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral Receives: Drug: SHR-1209 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in LDL-C at Week 12
Measured: Week 12
Secondary outcomes (19)
Change From Baseline in LDL-C at Week 12
Measured: Week 12
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Measured: Weeks 10 and 12
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Measured: Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol at the Mean of Weeks 10 and 12
Measured: Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol at Week 12
Measured: Week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Measured: Weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Measured: Week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Measured: Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Measured: Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Measured: Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Measured: Week 12
Percent Change From Baseline in Apo B at the Mean of Weeks 10 and 12
Measured: Weeks 10 and 12
Percent Change From Baseline in ApoB at Week 12
Measured: Week 12
Percent Change From Baseline in Apo A1 at the Mean of Weeks 10 and 12
Measured: Weeks 10 and 12
Percent Change From Baseline in Apo A1 at Week 12
Measured: Week 12
Percent Change From Baseline in Lipo(a) at the Mean of Weeks 10 and 12
Measured: Weeks 10 and 12
Percent Change From Baseline in Lipo(a) at Week 12
Measured: Week 12
Number of investigational product-related adverse events
Measured: Weeks 12 and 20
Number of ADA and Nab
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455581
- Sponsor's protocol ID
- SHR-1209-201
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.
PubMed 40587053
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-arm, Multicentre Study to Evaluate Efficacy and Safety of SHR-1209 in Subjects With Homozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04455581
- Acronym / sponsor ID
- SHR-1209-201
- Conditions
- Familial Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for at least 28 days, to receive subcutaneous SHR-1209, follow up 8 weeks. The primary endpoint was percentage change in LDL cholesterol from baseline at week 12 .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR-1209SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females ≥ 18 years of age
- Diagnosis of homozygous familial hypercholesterolemia
- Stable lipid-lowering therapies for at least 28 days
- LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
- Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
Key exclusion criteria (8 listed)
- LDL or plasma apheresis within 8 weeks prior to randomization
- New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
- Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months of randomization, Planned cardiac surgery or revascularization, Uncontrolled cardiac arrhythmia
- Liver transplant history.
- Uncontrolled hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1209SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral | Drug | Treatment group |
Primary outcome
Percent Change from Baseline in LDL-C at Week 12
Time frame: Week 12
19 secondary outcomes
Change From Baseline in LDL-C at Week 12
Time frame: Week 12
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol at Week 12
Time frame: Week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Time frame: Week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Time frame: Week 12
Percent Change From Baseline in Apo B at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in ApoB at Week 12
Time frame: Week 12
Percent Change From Baseline in Apo A1 at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in Apo A1 at Week 12
Time frame: Week 12
Percent Change From Baseline in Lipo(a) at the Mean of Weeks 10 and 12
Time frame: Weeks 10 and 12
Percent Change From Baseline in Lipo(a) at Week 12
Time frame: Week 12
Number of investigational product-related adverse events
Time frame: Weeks 12 and 20
Number of ADA and Nab
Time frame: Week 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Derived from this study: PubMed 40587053Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1209 in people with Familial Hypercholesterolemia, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Zhang, Medial Manager (+86 13671548369, zhangbin@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in LDL-C at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04455581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.