HyperlipidemiaPhase 3NCT07230730
A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
A Phase 3 study testing SHR-1918 in people with Hyperlipidemia, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- SHR-1918
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2026to Oct 2027
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the age must be at least 18 years old, and both men and women are eligible;
- the patient was receiving a stable dose of statins at the time of screening,, and the fasting LDL-C met: For individuals with extremely high risk of ASCVD, LDL-C≥1.4 mmol/L; for those with very high risk of ASCVD, LDL-C≥1.8 mmol/L; and for those with medium and high risk of ASCVD, ≥2.6 mol/L;
- Fasting TG≥ 1.7 mmol/L;
- Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.
Who cannot join
- poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) > 3× upper limit of normal (ULN), or total bilirubin > 2×ULN;
- Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN；
- The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m^2;
- Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc.
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
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jianan Wang
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.
- Conditions
- Hyperlipidemia
- Being tested
- SHR-1918, SHR-1918 placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1918Drug
SHR-1918
SHR-1918 placeboDrug
SHR-1918 placebo
| Study group | Role | What they receive |
|---|---|---|
| SHR-1918 low dose | Experimental | Not described Receives: Drug: SHR-1918 |
| SHR-1918 placebo low dose | Placebo comparator | Not described Receives: Drug: SHR-1918 placebo |
| SHR-1918 high dose | Experimental | Not described Receives: Drug: SHR-1918 |
| SHR-1918 placebo high dose | Placebo comparator | Not described Receives: Drug: SHR-1918 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change of serum LDL-C from baseline
Measured: Baseline and Week 24
The percentage change in serum TG from baseline
Measured: Baseline and Week 24
Secondary outcomes (24)
Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline
Measured: Baseline and Week 24
The percentage change in serum total cholesterol (TC) from baseline
Measured: Baseline and Week 24
The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24
Measured: Baseline and Week 24
The percentage change of serum apolipoprotein A1 (ApoA1) from baseline
Measured: Baseline and Week 24
The change from baseline in serum LDL-C
Measured: Baseline and Week 24
The change from baseline in serum TG
Measured: Baseline and Week 24
The change from baseline in serum non-HDL-C
Measured: Baseline and Week 24
The change from baseline in serum TC
Measured: Baseline and Week 24
The change from baseline in serum ApoB
Measured: Baseline and Week 24
The change from baseline in serum ApoA1
Measured: Baseline and Week 24
Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a))
Measured: Baseline and Week 24
Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C)
Measured: Baseline and Week 24
LDL-C goal attainment rates at Week 24, overall and by risk subgroup
Measured: Baseline and Week 24
Absolute and percentage change from baseline in serum non-HDL-C at Week 48
Measured: Baseline and Week 48
Absolute and percentage change from baseline in serum ApoB at Week 48
Measured: Baseline and Week 48
Absolute and percentage change from baseline in serum Lp(a) at Week 48
Measured: Baseline and Week 48
Absolute and percentage change from baseline in serum TC at Week 48
Measured: Baseline and Week 48
Absolute and percentage change from baseline in serum TG at Week 48
Measured: Baseline and Week 48
Absolute and percentage change from baseline in serum HDL-C at Week 48
Measured: Baseline and Week 48
Absolute and percentage change from baseline in serum ApoA1 at Week 48
Measured: Baseline and Week 48
LDL-C goal attainment rates at Week 48, overall and by risk subgroup
Measured: Baseline and Week 48
The incidence and severity of adverse events (AEs) throughout the study
Measured: up to week 52
Injection site reactions (pain, pruritus, erythema, swelling, induration, and rash) throughout the study
Measured: up to week 52
Major adverse cardiovascular events (Cardiovascular death, Non-fatal myocardial infarction, Non-fatal stroke and Coronary revascularization) throughout the study
Measured: up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start13 Jan 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 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
- NCT07230730
- Sponsor's protocol ID
- SHR-1918-302
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2025
- Last updated
- 10 Sep 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT07230730
- Acronym / sponsor ID
- SHR-1918-302
- Conditions
- Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Nov 2025 (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, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SHR-1918 low dose | Experimental | Drug: SHR-1918 |
| SHR-1918 placebo low dose | Placebo comparator | Drug: SHR-1918 placebo |
| SHR-1918 high dose | Experimental | Drug: SHR-1918 |
| SHR-1918 placebo high dose | Placebo comparator | Drug: SHR-1918 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the age must be at least 18 years old, and both men and women are eligible;
- the patient was receiving a stable dose of statins at the time of screening,, and the fasting LDL-C met: For individuals with extremely high risk of ASCVD, LDL-C≥1.4 mmol/L; for those with very high risk of ASCVD, LDL-C≥1.8 mmol/L; and for those with medium and high risk of ASCVD, ≥2.6 mol/L;
- Fasting TG≥ 1.7 mmol/L;
- Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.
Key exclusion criteria (5 listed)
- poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) > 3× upper limit of normal (ULN), or total bilirubin > 2×ULN;
- Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN；
- The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m^2;
- Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc.
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-1918SHR-1918 | Drug | SHR-1918 high dose, SHR-1918 low dose |
| SHR-1918 placeboSHR-1918 placebo | Drug | SHR-1918 placebo high dose, SHR-1918 placebo low dose |
Primary outcome
The percentage change of serum LDL-C from baseline
Time frame: Baseline and Week 24
The percentage change in serum TG from baseline
Time frame: Baseline and Week 24
24 secondary outcomes
Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline
Time frame: Baseline and Week 24
The percentage change in serum total cholesterol (TC) from baseline
Time frame: Baseline and Week 24
The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24
Time frame: Baseline and Week 24
The percentage change of serum apolipoprotein A1 (ApoA1) from baseline
Time frame: Baseline and Week 24
The change from baseline in serum LDL-C
Time frame: Baseline and Week 24
The change from baseline in serum TG
Time frame: Baseline and Week 24
The change from baseline in serum non-HDL-C
Time frame: Baseline and Week 24
The change from baseline in serum TC
Time frame: Baseline and Week 24
The change from baseline in serum ApoB
Time frame: Baseline and Week 24
The change from baseline in serum ApoA1
Time frame: Baseline and Week 24
Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a))
Time frame: Baseline and Week 24
Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C)
Time frame: Baseline and Week 24
LDL-C goal attainment rates at Week 24, overall and by risk subgroup
Time frame: Baseline and Week 24
Absolute and percentage change from baseline in serum non-HDL-C at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum ApoB at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum Lp(a) at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum TC at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum TG at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum HDL-C at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum ApoA1 at Week 48
Time frame: Baseline and Week 48
LDL-C goal attainment rates at Week 48, overall and by risk subgroup
Time frame: Baseline and Week 48
The incidence and severity of adverse events (AEs) throughout the study
Time frame: up to week 52
Injection site reactions (pain, pruritus, erythema, swelling, induration, and rash) throughout the study
Time frame: up to week 52
Major adverse cardiovascular events (Cardiovascular death, Non-fatal myocardial infarction, Non-fatal stroke and Coronary revascularization) throughout the study
Time frame: up to week 52
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 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
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-1918 in people with Hyperlipidemia, 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 5 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 10 Sep 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 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?
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 Sheng Qi (+86-0518-82342973, sheng.qi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change of serum LDL-C from baseline (time frame: Baseline and Week 24). 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 10 Sep 2026.