HyperlipidemicPhase 2NCT06109831
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic
A Phase 2 study testing SHR-1918 in people with Hyperlipidemic, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with Hyperlipidemic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipidemic
- What is being tested?
- SHR-1918
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 335 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2023to 4 Jul 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
- Regularly taking any moderate-intensity or higher dose* of statin stabilization therapy for ≥4 weeks at screening:
- ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L;
- ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L;
- ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L.
- Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose* statin stabilization therapy for ≥4 weeks;
- Fasting LDL-C ≥ 2.6 mmol/L.
- Fasting triglycerides ≤ 5.6 mmol/L.
Who cannot join
- Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%).
- eGFR <30ml/min/1.73m2 at the screening visit.
- CK >5times ULN at the screening visit.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: An Efficacy, Safety Study to Evaluate Multiple Subcutaneous SHR-1918 in Combination With Lipid-Lowering Drugs for the Stable Treatment of Hyperlipidemic Patients With Poor Lipid Control-A Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Study
This is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with Hyperlipidemic.
- Conditions
- Hyperlipidemic
- Being tested
- SHR-1918, SHR-1918 placebo
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 | Experimental | Not described Receives: Drug: SHR-1918 |
| SHR-1918 placebo | 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.
Percent change in calculated LDL-C from baseline to week 16
Measured: from baseline to week 16
Secondary outcomes (1)
Change in calculated LDL-C from baseline to week 16
Measured: from baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start24 Nov 2023
- Primary completion4 Jul 2025
- Study completion4 Jul 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 HyperlipidemicStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 335 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
- NCT06109831
- Sponsor's protocol ID
- SHR-1918-201
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xie X, Shi X, Zhang Y, Su S, Jiang C, Miao L, Wang J, Peng D, Lv L, Chai X, Luo S, Zheng Y, Huang S, Zhu D, Liao S, Ren M, Gao X, Yang H, Zhou H, He Y, Han Y, Xu J, Zhang L, Du L, Yao Z, Sheng J, Peng X, Chen X, Li J, Mi J, Lu Q, Wang H, Shen Z, Zhao Z, Gao F, Lv C, Zhu M, Zhu Y, Wang J. Angiopoietin-Like 3 Antibody Therapy in Patients With Suboptimally Controlled Hyperlipidemia: A Phase 2 Study. J Am Coll Cardiol. 2025 May 20;85(19):1821-1835. doi: 10.1016/j.jacc.2025.03.008. Epub 2025 Mar 31.
PubMed 40167414
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy, Safety Study to Evaluate Multiple Subcutaneous SHR-1918 in Combination With Lipid-Lowering Drugs for the Stable Treatment of Hyperlipidemic Patients With Poor Lipid Control-A Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06109831
- Acronym / sponsor ID
- SHR-1918-201
- Conditions
- Hyperlipidemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 31 Oct 2023 (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 is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with Hyperlipidemic.
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
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
| Arm | Type | Receives |
|---|---|---|
| SHR-1918 | Experimental | Drug: SHR-1918 |
| SHR-1918 placebo | Placebo comparator | Drug: 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 (7 listed)
- Regularly taking any moderate-intensity or higher dose* of statin stabilization therapy for ≥4 weeks at screening:
- Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose* statin stabilization therapy for ≥4 weeks;
- Fasting triglycerides ≤ 5.6 mmol/L.
Key exclusion criteria (3 listed)
- Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%).
- eGFR <30ml/min/1.73m2 at the screening visit.
- CK >5times ULN at the screening visit.
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 |
| SHR-1918 placeboSHR-1918 placebo | Drug | SHR-1918 placebo |
Primary outcome
Percent change in calculated LDL-C from baseline to week 16
Time frame: from baseline to week 16
1 secondary outcome
Change in calculated LDL-C from baseline to week 16
Time frame: from baseline to week 16
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 2 Feb 2026.
- Derived from this study: PubMed 40167414Xie X, Shi X, Zhang Y, Su S, Jiang C, Miao L, Wang J, Peng D, Lv L, Chai X, Luo S, Zheng Y, Huang S, Zhu D, Liao S, Ren M, Gao X, Yang H, Zhou H, He Y, Han Y, Xu J, Zhang L, Du L, Yao Z, Sheng J, Peng X, Chen X, Li J, Mi J, Lu Q, Wang H, Shen Z, Zhao Z, Gao F, Lv C, Zhu M, Zhu Y, Wang J. Angiopoietin-Like 3 Antibody Therapy in Patients With Suboptimally Controlled Hyperlipidemia: A Phase 2 Study. J Am Coll Cardiol. 2025 May 20;85(19):1821-1835. doi: 10.1016/j.jacc.2025.03.008. Epub 2025 Mar 31.
- Individual participant dataSharing planned: Undecided
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 testing SHR-1918 in people with Hyperlipidemic, 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 7 inclusion and 3 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 2 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. 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 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 16 (time frame: from baseline to week 16). 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 NCT06109831, 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 2 Feb 2026.