HypercholesterolemiaPhase 2/3NCT07404553
A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors
A Phase 2/3 study testing SHR-1918 Injection in people with Hypercholesterolemia, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- SHR-1918 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to Aug 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to provide a written informed consent.
- TG ≤ 5.6 mmol/L.
- LDL-C ≥ 2.6 mmol/L for moderate to high ASCVD risk, LDL-C ≥ 1.8 mmol/L for very high ASCVD risk, LDL-C ≥ 1.4 mmol/L for ultra-high ASCVD risk.
- Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol.
Who cannot join
- History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
- Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
- Acute ischemic ASCVD events within 3 months prior to screening or randomization.
- Have severe cardiac arrhythmia within 3 months prior to screening or randomization.
- Echocardiography indicates a left ventricular ejection fraction (LVEF) of less than 30% within 3 months prior to screening.
- History of percutaneous coronary intervention, history of coronary artery bypass grafting (CABG), history of peripheral arterial revascularisation within 1 month prior to screening or randomization.
Show all 15Show fewer
- Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
- Have a history of diseases that significantly affect blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or have severe arrhythmia prior to screening or randomization.
- Malignant tumors within 5 years.
- It's planned to research transcutaneous coronary intervention, coronary artery bypass grafting, carotid or peripheral artery reconstruction, pacemaker implantation, cardiac resynchronisation therapy (CRT), implantable cardioverter defibrillator (ICD) implantation and other implantations during the study.
- Received plasma exchange therapy within 2 months prior to screening, or plans to receive plasma exchange therapy during the study period, or has received LDL receptor gene therapy prior to screening.
- Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.
- History of drug use, substance abuse, and alcohol abuse.
- Participated in or is participating in other clinical studies and has received study interventions within the past month prior to screening.
- Researchers determine that the subject has poor compliance or any factors that make them unsuitable for participation in this trial, including but not limited to participation in the study placing the subject at unacceptable risk or potentially interfering with the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Shaoliang Chen, +86-13605157029, chmengx@126.com
Shaoliang Chen
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors
The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.
- Conditions
- Hypercholesterolemia
- Being tested
- SHR-1918 Injection, SHR-1918 Injection Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1918 InjectionDrug
SHR-1918 injection.
SHR-1918 Injection PlaceboDrug
SHR-1918 injection placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1918 Injection Group | Experimental | SHR-1918 injection. Receives: Drug: SHR-1918 Injection |
| SHR-1918 Injection Placebo Group | Placebo comparator | SHR-1918 injection placebo. Receives: Drug: SHR-1918 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 12 relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 24 relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Secondary outcomes (40)
Percentage change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Percentage change in triglyceride (TG) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Percentage change in total cholesterol (TC) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Percentage change in apolipoprotein B (ApoB) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Percentage change in Apolipoprotein A1 (ApoA1) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Change in triglyceride (TG) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Change in total cholesterol (TC) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Change in apolipoprotein B (ApoB) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Change in Apolipoprotein A1 (ApoA1) relative to baseline.
Phase 2.
Measured: AT 12 weeks of treatment.
Change in Lipoprotein(a) (Lp(a)) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Percentage change in Lipoprotein(a) (Lp(a)) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Change in high-density lipoprotein cholesterol (HDL-C) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Percentage change in high-density lipoprotein cholesterol (HDL-C) relative to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Proportion of subjects with the overall LDL-C achievement rate.
Phase 2.
Measured: At 12 weeks of treatment.
Proportion of subjects with the LDL-C achievement rates in different risk groups.
Phase 2.
Measured: At 12 weeks of treatment.
Change in LDL-C decreased by ≥ 50% to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Percentage change in LDL-C decreased by ≥ 50% to baseline.
Phase 2.
Measured: At 12 weeks of treatment.
Incidence and severity of adverse events (AEs).
Phase 2.
Measured: Approximately 12 weeks.
Incidence and severity of injection site reactions.
Phase 2.
Measured: Approximately 12 weeks.
Percentage change in non-HDL-C relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Percentage change in TG relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Percentage change in TC relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Percentage change in ApoB relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Percentage change in ApoA1 relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Change in TG relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Change in non-HDL-C relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Change in TC relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Change in ApoB relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Change in ApoA1 relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Change in Lp(a) relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Percentage change in Lp(a) relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Change in HDL-C relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Percentage change in HDL-C relative to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Proportion of subjects with the overall LDL-C achievement rate.
Phase 3.
Measured: At 24 weeks of treatment.
Proportion of subjects with the LDL-C achievement rates in different risk groups.
Phase 3.
Measured: At 24 weeks of treatment.
Change in LDL-C decreased by ≥ 50% to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Percentage change in LDL-C decreased by ≥ 50% to baseline.
Phase 3.
Measured: At 24 weeks of treatment.
Incidence and severity of adverse events (AEs).
Phase 3.
Measured: Approximately 24 weeks.
Incidence and severity of injection site reactions.
Phase 3.
Measured: Approximately 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start30 Apr 2026
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals Co., LtdThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404553
- Sponsor's protocol ID
- SHR-1918-303
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors
- ClinicalTrials.gov ID
- NCT07404553
- Acronym / sponsor ID
- SHR-1918-303
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 11 Feb 2026 (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 purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1918 Injection Group | Experimental | Drug: SHR-1918 InjectionSHR-1918 injection. |
| SHR-1918 Injection Placebo Group | Placebo comparator | Drug: SHR-1918 Injection PlaceboSHR-1918 injection placebo. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to provide a written informed consent.
- TG ≤ 5.6 mmol/L.
- LDL-C ≥ 2.6 mmol/L for moderate to high ASCVD risk, LDL-C ≥ 1.8 mmol/L for very high ASCVD risk, LDL-C ≥ 1.4 mmol/L for ultra-high ASCVD risk.
- Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol.
Key exclusion criteria (15 listed)
- History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
- Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
- Acute ischemic ASCVD events within 3 months prior to screening or randomization.
- Have severe cardiac arrhythmia within 3 months prior to screening or randomization.
- Echocardiography indicates a left ventricular ejection fraction (LVEF) of less than 30% within 3 months prior to screening.
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-1918 InjectionSHR-1918 injection. | Drug | SHR-1918 Injection Group |
| SHR-1918 Injection PlaceboSHR-1918 injection placebo. | Drug | SHR-1918 Injection Placebo Group |
Primary outcome
Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 12 relative to baseline.
Time frame: At 12 weeks of treatment.
Phase 2.
Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 24 relative to baseline.
Time frame: At 24 weeks of treatment.
Phase 3.
40 secondary outcomes
Percentage change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline.
Time frame: At 12 weeks of treatment.
Percentage change in triglyceride (TG) relative to baseline.
Time frame: At 12 weeks of treatment.
Percentage change in total cholesterol (TC) relative to baseline.
Time frame: At 12 weeks of treatment.
Percentage change in apolipoprotein B (ApoB) relative to baseline.
Time frame: At 12 weeks of treatment.
Percentage change in Apolipoprotein A1 (ApoA1) relative to baseline.
Time frame: At 12 weeks of treatment.
Change in triglyceride (TG) relative to baseline.
Time frame: At 12 weeks of treatment.
Change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline.
Time frame: At 12 weeks of treatment.
Change in total cholesterol (TC) relative to baseline.
Time frame: At 12 weeks of treatment.
Change in apolipoprotein B (ApoB) relative to baseline.
Time frame: At 12 weeks of treatment.
Change in Apolipoprotein A1 (ApoA1) relative to baseline.
Time frame: AT 12 weeks of treatment.
Change in Lipoprotein(a) (Lp(a)) relative to baseline.
Time frame: At 12 weeks of treatment.
Percentage change in Lipoprotein(a) (Lp(a)) relative to baseline.
Time frame: At 12 weeks of treatment.
Change in high-density lipoprotein cholesterol (HDL-C) relative to baseline.
Time frame: At 12 weeks of treatment.
Percentage change in high-density lipoprotein cholesterol (HDL-C) relative to baseline.
Time frame: At 12 weeks of treatment.
Proportion of subjects with the overall LDL-C achievement rate.
Time frame: At 12 weeks of treatment.
Proportion of subjects with the LDL-C achievement rates in different risk groups.
Time frame: At 12 weeks of treatment.
Change in LDL-C decreased by ≥ 50% to baseline.
Time frame: At 12 weeks of treatment.
Percentage change in LDL-C decreased by ≥ 50% to baseline.
Time frame: At 12 weeks of treatment.
Incidence and severity of adverse events (AEs).
Time frame: Approximately 12 weeks.
Incidence and severity of injection site reactions.
Time frame: Approximately 12 weeks.
Percentage change in non-HDL-C relative to baseline.
Time frame: At 24 weeks of treatment.
Percentage change in TG relative to baseline.
Time frame: At 24 weeks of treatment.
Percentage change in TC relative to baseline.
Time frame: At 24 weeks of treatment.
Percentage change in ApoB relative to baseline.
Time frame: At 24 weeks of treatment.
Percentage change in ApoA1 relative to baseline.
Time frame: At 24 weeks of treatment.
Change in TG relative to baseline.
Time frame: At 24 weeks of treatment.
Change in non-HDL-C relative to baseline.
Time frame: At 24 weeks of treatment.
Change in TC relative to baseline.
Time frame: At 24 weeks of treatment.
Change in ApoB relative to baseline.
Time frame: At 24 weeks of treatment.
Change in ApoA1 relative to baseline.
Time frame: At 24 weeks of treatment.
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 24 weeks of treatment.
Change in HDL-C relative to baseline.
Time frame: At 24 weeks of treatment.
Percentage change in HDL-C relative to baseline.
Time frame: At 24 weeks of treatment.
Proportion of subjects with the overall LDL-C achievement rate.
Time frame: At 24 weeks of treatment.
Proportion of subjects with the LDL-C achievement rates in different risk groups.
Time frame: At 24 weeks of treatment.
Change in LDL-C decreased by ≥ 50% to baseline.
Time frame: At 24 weeks of treatment.
Percentage change in LDL-C decreased by ≥ 50% to baseline.
Time frame: At 24 weeks of treatment.
Incidence and severity of adverse events (AEs).
Time frame: Approximately 24 weeks.
Incidence and severity of injection site reactions.
Time frame: Approximately 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SHR-1918 Injection in people with Hypercholesterolemia, run by Beijing Suncadia Pharmaceuticals 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 15 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miaomiao Shi (+86-0518-82342973, miaomiao.shi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 12 relative to baseline. (time frame: At 12 weeks of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2026.