HyperlipidemiaPhase 2NCT06471218
Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
A Phase 2 study of Hyperlipidemia, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipidemia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2024to 16 May 2025
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible;
- Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the relevant conditions;
- TG≤5.6mmol/L.
Who cannot join
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;
- Human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), any of the above test results are positive; Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA ≥ 1000 copies/ml (or ≥ 200 IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200 IU/ml, HBV-DNA ≥ the lower limit of the detection value);
- Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
- Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);
- Glomerular filtration rate (eGFR)<30 ml/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/L).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1918 in Patients With Hyperlipidemia in Poor Control: a Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trials
Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials
- 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-1918; SHR-1918 PlaceboDrug
SHR-1918/SHR-1918 Placebo,two administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment A:SHR-1918/SHR-1918 Placebo | Experimental | Not described Receives: Drug: SHR-1918; SHR-1918 Placebo |
| Treatment B:SHR-1918/SHR-1918 Placebo | Experimental | Not described Receives: Drug: SHR-1918; SHR-1918 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in calculated LDL-C from baseline to week 24
Measured: from baseline to week 24
Secondary outcomes (1)
Percent change in calculated TG from baseline to week 24
Measured: from baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start2 Jul 2024
- Primary completion16 May 2025
- Study completion16 May 2025
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 HyperlipidemiaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
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
- NCT06471218
- Sponsor's protocol ID
- SHR-1918-203
- Status last verified
- Feb 2026
- First submitted
- 18 Jun 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhong W, Zhang J, Zhu D, Pei H, Wu W, Huang R, Yin D, Gao X, Li B, Lv C, Zhu M, Zhu Y, Zhong Z. Efficacy and Safety of Quarterly Dosing SHR-1918 in Patients With Suboptimally Controlled Hyperlipidemia. JACC Asia. 2026 Sep 3:S2772-3747(26)00608-3. doi: 10.1016/j.jacasi.2026.07.017. Online ahead of print.
PubMed 42714362
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1918 in Patients With Hyperlipidemia in Poor Control: a Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trials
- ClinicalTrials.gov ID
- NCT06471218
- Acronym / sponsor ID
- SHR-1918-203
- Conditions
- Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 24 Jun 2024 (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.
Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials
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 |
|---|---|---|
| Treatment A:SHR-1918/SHR-1918 Placebo | Experimental | Drug: SHR-1918; SHR-1918 Placebo |
| Treatment B:SHR-1918/SHR-1918 Placebo | Experimental | Drug: SHR-1918; SHR-1918 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible;
- Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the relevant conditions;
- TG≤5.6mmol/L.
Key exclusion criteria (5 listed)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;
- Human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), any of the above test results are positive; Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA ≥ 1000 copies/ml (or ≥ 200 IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200 IU/ml, HBV-DNA ≥ the lower limit of the detection value);
- Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
- Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);
- Glomerular filtration rate (eGFR)<30 ml/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/L).
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; SHR-1918 PlaceboSHR-1918/SHR-1918 Placebo,two administration | Drug | Treatment A:SHR-1918/SHR-1918 Placebo, Treatment B:SHR-1918/SHR-1918 Placebo |
Primary outcome
Percent change in calculated LDL-C from baseline to week 24
Time frame: from baseline to week 24
1 secondary outcome
Percent change in calculated TG from baseline to week 24
Time frame: from baseline to week 24
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 5 Feb 2026.
- Derived from this study: PubMed 42714362Zhong W, Zhang J, Zhu D, Pei H, Wu W, Huang R, Yin D, Gao X, Li B, Lv C, Zhu M, Zhu Y, Zhong Z. Efficacy and Safety of Quarterly Dosing SHR-1918 in Patients With Suboptimally Controlled Hyperlipidemia. JACC Asia. 2026 Sep 3:S2772-3747(26)00608-3. doi: 10.1016/j.jacasi.2026.07.017. Online ahead of print.
- 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. 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 2 study of 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 3 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: finished, as of the sponsor's last update on 5 Feb 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent change in calculated LDL-C from baseline to week 24 (time frame: from baseline to week 24). 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 NCT06471218, 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 5 Feb 2026.