Primary HypercholesterolemiaPhase 3NCT04849000
Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage
A Phase 3 study testing SHR-1209 in people with Primary Hypercholesterolemia and Mixed Hyperlipemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia and hyperlipemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Hypercholesterolemia, Mixed Hyperlipemia
- What is being tested?
- SHR-1209
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 709 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2021to 13 Jan 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;
- Fasting LDL-C was ≥2.6mmol/L and <4.9mmol/L at screening and randomization；
- Those who understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent in person.
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 cardiac function as defined by the New York Heart Association (NYHA) grade III-IV;
- Any of the laboratory indicators met the following criteria at screening or at random :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 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
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, 510120
About this study
Official title: Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of SHR-1209 Monotherapy in Patients With Primary Hypercholesterolemia and Mixed Hyperlipemia
The study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia and hyperlipemia.
- Conditions
- Primary Hypercholesterolemia, Mixed Hyperlipemia
- Being tested
- SHR-1209, SHR-1209 Placebo
- Medical subject headings
- Hyperlipoproteinemia Type V
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1209Drug
SHR-1209
SHR-1209 PlaceboDrug
SHR-1209 Placebo
| Study group | Role | What they receive |
|---|---|---|
| SHR-1209 | Experimental | Not described Receives: Drug: SHR-1209 |
| SHR-1209 Placebo | Placebo comparator | Not described Receives: Drug: SHR-1209 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-weeks or 16weeks Percentage change in LDL-C relative to baseline
Measured: 12-weeks or 16weeks
Secondary outcomes (2)
12-weeks or 16weeks change in LDL-C relative to baseline；
Measured: 12-weeks or 16weeks
Percentage of changes in non-HDL-C, ApoB, TC/HDL-C, ApoB/ApoA1, LP (a) and TG relative to baseline and relative to baseline after 12 weeks or 16 weeks of treatment
Measured: 12 weeks or 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start23 Apr 2021
- Primary completion21 Jun 2022
- Study completion13 Jan 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 Primary 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 monotherapy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 709 participants (actual)
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
- NCT04849000
- Sponsor's protocol ID
- SHR-1209-301
- Status last verified
- Jun 2022
- First submitted
- 31 Mar 2021
- Last updated
- 19 May 2023
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of SHR-1209 Monotherapy in Patients With Primary Hypercholesterolemia and Mixed Hyperlipemia
- ClinicalTrials.gov ID
- NCT04849000
- Acronym / sponsor ID
- SHR-1209-301
- Conditions
- Primary Hypercholesterolemia, Mixed Hyperlipemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 709 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 19 Apr 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.
The study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia and hyperlipemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SHR-1209 monotherapy
| Arm | Type | Receives |
|---|---|---|
| SHR-1209 | Experimental | Drug: SHR-1209 |
| SHR-1209 Placebo | Placebo comparator | 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 (3 listed)
- Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
- Fasting LDL-C was ≥2.6mmol/L and <4.9mmol/L at screening and randomization；
- Those who understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent in person.
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 cardiac function as defined by the New York Heart Association (NYHA) grade III-IV;
- Any of the laboratory indicators met the following criteria at screening or at random :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 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-1209SHR-1209 | Drug | SHR-1209 |
| SHR-1209 PlaceboSHR-1209 Placebo | Drug | SHR-1209 Placebo |
Primary outcome
12-weeks or 16weeks Percentage change in LDL-C relative to baseline
Time frame: 12-weeks or 16weeks
2 secondary outcomes
12-weeks or 16weeks change in LDL-C relative to baseline；
Time frame: 12-weeks or 16weeks
Percentage of changes in non-HDL-C, ApoB, TC/HDL-C, ApoB/ApoA1, LP (a) and TG relative to baseline and relative to baseline after 12 weeks or 16 weeks of treatment
Time frame: 12 weeks or 16 weeks
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 19 May 2023.
- 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.
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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 testing SHR-1209 in people with Primary Hypercholesterolemia and Mixed Hyperlipemia, 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 3 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 19 May 2023. 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. Some participants in this study may receive a placebo. 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?
12-weeks or 16weeks Percentage change in LDL-C relative to baseline (time frame: 12-weeks or 16weeks). 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 NCT04849000, 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 19 May 2023.