Primary HypercholesterolemiaPhase 3NCT04844125
SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research
A Phase 3 study testing SHR-1209 in people with Primary Hypercholesterolemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- SHR-1209
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2021to 12 Aug 2022
- 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
- Any male or female aged between 18 and 80 on the date of signing the informed consent;
- Diagnosed as hypercholesterolemia ;
- Fasting triglyceride was less than 5.6 mmol/L during screening:
- Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Who cannot join
- A history of the following diseases or treatments during the screening period:
- Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past;
- Participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer);
- Any of the laboratory test indicators meets the following criteria:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 3 times the upper limit of normal value (ULN), and total bilirubin was more than 2 times ULN during the screening period or at random;
- The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random;
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- Have used the following drugs:
- PCSK9 inhibitors had been used in the previous 6 months;
- Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened.
- Other circumstances:
- Women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;Women who are pregnant or breastfeeding;Not agreed during the trial or at 24 weeks after the last dose
- Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentric, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 in Patients With Hypercholesterolemia
This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.
- Conditions
- Primary Hypercholesterolemia
- Being tested
- SHR-1209, SHR-1209 Placebo
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 Percentage change in serum LDL-C levels from baseline.
Measured: 12 weeks
Secondary outcomes (2)
12 weeks Absolute Changes in serum LDL-C levels from baseline；
Measured: 12 weeks
12 weeks Percentage change of non-HDL-C relative to baseline；
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start14 Apr 2021
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Background Lipolowering therapy in combination with SHR-1209/ placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 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
- NCT04844125
- Sponsor's protocol ID
- SHR-1209-303
- Status last verified
- May 2022
- First submitted
- 2 Apr 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li L, Zhou Y, Deng C, Sheng J, Peng D, Ling Z, Wang L, Dai C, Huang K, Lian Q, Yu Z, Yang H, Hu Y, Dong Y, Wang N, Wang Z, Zhang W, Han X, Yao Z, Liu Q, Liang Y, Xu B, Wang Y, Zhong T, Chen J. Recaticimab in adult heterozygous familial hypercholesterolaemia (REMAIN-3): a multicentre, randomized, double-blind, placebo-controlled Phase 3 study. Cardiovasc Res. 2025 Oct 24;121(12):1856-1864. doi: 10.1093/cvr/cvaf155.
PubMed 40911402Shu 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04844125
- Acronym / sponsor ID
- SHR-1209-303
- Conditions
- Primary Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 14 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.
This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.
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
- Background Lipolowering therapy in combination with SHR-1209/ placebo
| 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 (4 listed)
- Any male or female aged between 18 and 80 on the date of signing the informed consent;
- Diagnosed as hypercholesterolemia ;
- Fasting triglyceride was less than 5.6 mmol/L during screening:
- Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Key exclusion criteria (12 listed)
- A history of the following diseases or treatments during the screening period:
- Any of the laboratory test indicators meets the following criteria:
- Have used the following drugs:
- Other circumstances:
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 Percentage change in serum LDL-C levels from baseline.
Time frame: 12 weeks
2 secondary outcomes
12 weeks Absolute Changes in serum LDL-C levels from baseline；
Time frame: 12 weeks
12 weeks Percentage change of non-HDL-C relative to baseline；
Time frame: 12 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 25 Apr 2023.
- Derived from this study: PubMed 40911402Li L, Zhou Y, Deng C, Sheng J, Peng D, Ling Z, Wang L, Dai C, Huang K, Lian Q, Yu Z, Yang H, Hu Y, Dong Y, Wang N, Wang Z, Zhang W, Han X, Yao Z, Liu Q, Liang Y, Xu B, Wang Y, Zhong T, Chen J. Recaticimab in adult heterozygous familial hypercholesterolaemia (REMAIN-3): a multicentre, randomized, double-blind, placebo-controlled Phase 3 study. Cardiovasc Res. 2025 Oct 24;121(12):1856-1864. doi: 10.1093/cvr/cvaf155.
- 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, 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 12 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 25 Apr 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 Percentage change in serum LDL-C levels from baseline. (time frame: 12 weeks). 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 NCT04844125, which also lists 2 linked publications.
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 25 Apr 2023.