Non-familial HypercholesterolemiaPhase 3NCT04885218

Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia

A Phase 3 study of Non-familial Hypercholesterolemia and Mixed Hyperlipidemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SHR-1209 subcutaneous administration in patients with non-familial hypercholesterolemia and mixed hyperlipidemia after lipid-lowering therapy Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Non-familial Hypercholesterolemia, Mixed Hyperlipidemia
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 692 participants
Where: 1 siteChina
Study dates: 30 Jul 2021to 23 May 2023
Phase: Phase 3
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

Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
The report of LDL-C should be higher than the ideal lipid-lowering target according to ASCVD history;
Fasting triglycerides less than equal to 5.6 mmol/L；
Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Who cannot join

Have the following diseases or treatment history : (1) Have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of familial hypercholesterolemia according to Simon Broome Criteria;(3) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization or latest detected LVEF<30%;(4) CVD events within 3 months; (5) uncontrolled hypertension; (6) prior exposure to recaticimab or other PCSK9 inhibitors; (7) inadequate organ functions.
Any of the laboratory indicators met the following criteria at screening or at randomization :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
General conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) Fertile female subjects who did not use contraception within 4 weeks before screening; Or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) Women who are pregnant or lactating.
The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Anzhen hospital
Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in the Stable Treatment of Patients With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia .

Conditions: Non-familial Hypercholesterolemia, Mixed Hyperlipidemia
Being tested: SHR-1209 ;placebo
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-1209 ;placeboDrug
SHR-1209 and placebo 150 mg subcutaneous injection once every 4 weeks for 48 weeks
SHR-1209 ;placeboDrug
SHR-1209 and placebo 300 mg subcutaneous injection once every 8 weeks for 48 weeks
SHR-1209 ;placeboDrug
SHR-1209 and placebo 450 mg subcutaneous injection once every 12 weeks for 48 weeks

Study groups in NCT04885218
Study group	Role	What they receive
Cohort 1：SHR-1209 / placebo	Experimental	Not described Receives: Drug: SHR-1209 ;placebo
Cohort 2：SHR-1209 /placebo	Experimental	Not described Receives: Drug: SHR-1209 ;placebo
Cohort 3：SHR-1209 / placebo	Experimental	Not described Receives: Drug: SHR-1209 ;placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage change in LDL-C relative to baseline
Measured: at 24 weeks of treatment

Secondary outcomes (17)

The value of change in LDL-C relative to baseline
Measured: at 24 weeks of treatment
Percentage change in LDL-C relative to baseline
Measured: at 48 weeks of treatment;
The value of change in LDL-C relative to baseline ,
Measured: at 48 weeks of treatment;
Percentage change in non-HDL-C relative to baseline
Measured: at 24 weeks of treatment;
Percentage change in non-HDL-C relative to baseline
Measured: at 48 weeks of treatment;
Percentage change in ApoB relative to baseline
Measured: at 24 weeks of treatment;
Percentage change in ApoB relative to baseline
Measured: at 48 weeks of treatment;
Percentage change in TC/HDL-C relative to baseline
Measured: at 24 weeks of treatment;
Percentage change in TC/HDL-C relative to baseline,
Measured: at 48 weeks of treatment
Percentage change in ApoB/ApoA1 relative to baseline,
Measured: at 24 weeks of treatment;
Percentage change in ApoB/ApoA1 relative to baseline,
Measured: at 48 weeks of treatment;
Percentage change in LP (a) relative to baseline,
Measured: at 24 weeks of treatment;
Percentage change in LP (a) relative to baseline,
Measured: at 48 weeks of treatment;
Percentage change in TG relative to baseline
Measured: at 24 weeks of treatment
Percentage change in TG relative to baseline
Measured: at 48 weeks of treatment;
Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,
Measured: at 48 weeks of treatment;
Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,
Measured: at 48 weeks of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202123 May 2023

First posted13 May 2021
Study start30 Jul 2021
Primary completion23 May 2023
Study completion23 May 2023

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 Non-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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: SHR-1209 combined with lipid-lowering agents
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 692 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04885218
Sponsor's protocol ID: SHR-1209-302
Status last verified: Jan 2024
First submitted: 30 Apr 2021
Last updated: 31 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
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RecruitingPhase 3
Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
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Active, not recruiting
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All Non-familial Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in the Stable Treatment of Patients With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia .
ClinicalTrials.gov ID: NCT04885218
Acronym / sponsor ID: SHR-1209-302
Conditions: Non-familial Hypercholesterolemia, Mixed Hyperlipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 692 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Jul 2021 (actual)
Primary completion: 23 May 2023 (actual)
Study completion: 23 May 2023 (actual)
First posted: 13 May 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: SHR-1209 combined with lipid-lowering agents

Arm	Type	Receives
Cohort 1：SHR-1209 / placebo	Experimental	Drug: SHR-1209 ;placebo
Cohort 2：SHR-1209 /placebo	Experimental	Drug: SHR-1209 ;placebo
Cohort 3：SHR-1209 / placebo	Experimental	Drug: SHR-1209 ;placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
The report of LDL-C should be higher than the ideal lipid-lowering target according to ASCVD history;
Fasting triglycerides less than equal to 5.6 mmol/L；
Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Key exclusion criteria (4 listed)

Have the following diseases or treatment history : (1) Have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of familial hypercholesterolemia according to Simon Broome Criteria;(3) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization or latest detected LVEF<30%;(4) CVD events within 3 months; (5) uncontrolled hypertension; (6) prior exposure to recaticimab or other PCSK9 inhibitors; (7) inadequate organ functions.
Any of the laboratory indicators met the following criteria at screening or at randomization :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
General conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) Fertile female subjects who did not use contraception within 4 weeks before screening; Or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) Women who are pregnant or lactating.
The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.

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-1209 ;placeboSHR-1209 and placebo 150 mg subcutaneous injection once every 4 weeks for 48 weeks	Drug	Cohort 1：SHR-1209 / placebo
SHR-1209 ;placeboSHR-1209 and placebo 300 mg subcutaneous injection once every 8 weeks for 48 weeks	Drug	Cohort 2：SHR-1209 /placebo
SHR-1209 ;placeboSHR-1209 and placebo 450 mg subcutaneous injection once every 12 weeks for 48 weeks	Drug	Cohort 3：SHR-1209 / placebo

Primary outcome

Percentage change in LDL-C relative to baseline
Time frame: at 24 weeks of treatment

17 secondary outcomes

The value of change in LDL-C relative to baseline
Time frame: at 24 weeks of treatment
Percentage change in LDL-C relative to baseline
Time frame: at 48 weeks of treatment;
The value of change in LDL-C relative to baseline ,
Time frame: at 48 weeks of treatment;
Percentage change in non-HDL-C relative to baseline
Time frame: at 24 weeks of treatment;
Percentage change in non-HDL-C relative to baseline
Time frame: at 48 weeks of treatment;
Percentage change in ApoB relative to baseline
Time frame: at 24 weeks of treatment;
Percentage change in ApoB relative to baseline
Time frame: at 48 weeks of treatment;
Percentage change in TC/HDL-C relative to baseline
Time frame: at 24 weeks of treatment;
Percentage change in TC/HDL-C relative to baseline,
Time frame: at 48 weeks of treatment
Percentage change in ApoB/ApoA1 relative to baseline,
Time frame: at 24 weeks of treatment;
Percentage change in ApoB/ApoA1 relative to baseline,
Time frame: at 48 weeks of treatment;
Percentage change in LP (a) relative to baseline,
Time frame: at 24 weeks of treatment;
Percentage change in LP (a) relative to baseline,
Time frame: at 48 weeks of treatment;
Percentage change in TG relative to baseline
Time frame: at 24 weeks of treatment
Percentage change in TG relative to baseline
Time frame: at 48 weeks of treatment;
Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,
Time frame: at 48 weeks of treatment;
Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,
Time frame: at 48 weeks of treatment.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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.

Related trials for Non-familial Hypercholesterolemia

Not yet recruitingPhase 3
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
Coronary Atherosclerosis, Mixed Dyslipidemia
Active, not recruitingPhase 3
IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
Recruiting
"Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)"
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingPhase 3
Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
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Active, not recruiting
An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Non-familial Hypercholesterolemia and Mixed Hyperlipidemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in LDL-C relative to baseline (time frame: at 24 weeks of treatment). 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 NCT04885218, 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 31 Jan 2024.