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RecruitingNCT07404553Updated Jun 16, 2026

A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors

A Phase 2/3 interventional study of SHR-1918 Injection and SHR-1918 Injection Placebo in Hypercholesterolemia, sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.

This study's planned enrollment of 126 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd is the lead sponsor of 25 studies on the registry; 9 are open to participants now.

Browse Beijing Suncadia Pharmaceuticals Co., Ltd studies →All Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to provide a written .
  2. TG ≤ 5.6 mmol/L.
  3. 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.
  4. Male and female subjects of 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 methods as specified in the protocol.

Exclusion criteria

Exclusion Criteria:

  1. History of severe allergies/ reactions, or allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
  2. Heart failure with (NYHA) Class III-IV prior to screening or randomization.
  3. Acute ischemic ASCVD events within 3 months prior to screening or randomization.
  4. Have severe cardiac arrhythmia within 3 months prior to screening or randomization.
  5. Echocardiography indicates a (LVEF) of less than 30% within 3 months prior to screening.
  6. 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.
  7. Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
  8. 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.
  9. Malignant tumors within 5 years.
  10. 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.
  11. 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.
  12. Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.
  13. History of drug use, substance abuse, and alcohol abuse.
  14. Participated in or is participating in other clinical studies and has received study interventions within the past month prior to screening.
  15. 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (estimated)

Study arms

  • Experimental
    SHR-1918 Injection Group

    SHR-1918 injection.

    Drug: SHR-1918 Injection

  • Placebo comparator
    SHR-1918 Injection Placebo Group

    SHR-1918 injection placebo.

    Drug: SHR-1918 Injection Placebo

Interventions

  • DrugSHR-1918 Injection

    SHR-1918 injection.

  • DrugSHR-1918 Injection Placebo

    SHR-1918 injection placebo.

06

What researchers measure

Primary outcomes

  1. Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 12 relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  2. Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 24 relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

Secondary outcomes

  1. Percentage change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  2. Percentage change in triglyceride (TG) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  3. Percentage change in total cholesterol (TC) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  4. Percentage change in apolipoprotein B (ApoB) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  5. Percentage change in Apolipoprotein A1 (ApoA1) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  6. Change in triglyceride (TG) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  7. Change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  8. Change in total cholesterol (TC) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  9. Change in apolipoprotein B (ApoB) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  10. Change in Apolipoprotein A1 (ApoA1) relative to baseline.

    Phase 2.

    Time frame: AT 12 weeks of treatment.

  11. Change in Lipoprotein(a) (Lp(a)) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  12. Percentage change in Lipoprotein(a) (Lp(a)) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  13. Change in high-density lipoprotein cholesterol (HDL-C) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  14. Percentage change in high-density lipoprotein cholesterol (HDL-C) relative to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  15. Proportion of subjects with the overall LDL-C achievement rate.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  16. Proportion of subjects with the LDL-C achievement rates in different risk groups.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  17. Change in LDL-C decreased by ≥ 50% to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  18. Percentage change in LDL-C decreased by ≥ 50% to baseline.

    Phase 2.

    Time frame: At 12 weeks of treatment.

  19. Incidence and severity of adverse events (AEs).

    Phase 2.

    Time frame: Approximately 12 weeks.

  20. Incidence and severity of injection site reactions.

    Phase 2.

    Time frame: Approximately 12 weeks.

  21. Percentage change in non-HDL-C relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  22. Percentage change in TG relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  23. Percentage change in TC relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  24. Percentage change in ApoB relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  25. Percentage change in ApoA1 relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  26. Change in TG relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  27. Change in non-HDL-C relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  28. Change in TC relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  29. Change in ApoB relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  30. Change in ApoA1 relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  31. Change in Lp(a) relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  32. Percentage change in Lp(a) relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  33. Change in HDL-C relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  34. Percentage change in HDL-C relative to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  35. Proportion of subjects with the overall LDL-C achievement rate.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  36. Proportion of subjects with the LDL-C achievement rates in different risk groups.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  37. Change in LDL-C decreased by ≥ 50% to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  38. Percentage change in LDL-C decreased by ≥ 50% to baseline.

    Phase 3.

    Time frame: At 24 weeks of treatment.

  39. Incidence and severity of adverse events (AEs).

    Phase 3.

    Time frame: Approximately 24 weeks.

  40. Incidence and severity of injection site reactions.

    Phase 3.

    Time frame: Approximately 24 weeks.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Jul 2028, 27 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2026
First posted
Feb 11, 2026
StartActual
Apr 30, 2026
Primary completionEst.
Jul 2028
CompletionEst.
Aug 2028
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07404553
Lead sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
Responsible party
Sponsor
First posted
Feb 11, 2026
Start date
Apr 30, 2026
Primary completion
Jul 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Jun 16, 2026

Study contacts

Miaomiao Shi
Contact
miaomiao.shi@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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