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Active, not recruitingNCT07349615Updated Oct 20, 2026

A Study of SHR-1918 In Participants With Hypertriglyceridemia

A Phase 3 interventional study of SHR-1918/ SHR-1918 placebo and SHR-1918/ SHR-1918 placebo in Hypertriglyceridemia, sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

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

Updated Oct 20, 2026Now Active, not recruitingStart date moved+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
367
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-weeks treatment.

02

Conditions studied

  • Hypertriglyceridemia

Browse trials for

03

In context

Hypertriglyceridemia

324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.

This study's enrollment of 367 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

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

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

04

Who can participate

Ages eligible
18 Years and older
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, who is able and willing to provide a written .
  2. 1.7 ≤ TG ≤ 5.6 mmol/L.
  3. LDL-C \< 3.4 mmol/L.
  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. Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
  3. Have a history of pancreatitis prior to screening or randomization.
  4. Acute ischemic ASCVD events within 3 months prior to screening or randomization.
  5. Heart failure with (NYHA) Class III-IV prior to screening or randomization.
  6. Malignant tumors within 5 years.
  7. 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.
  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. Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
  10. Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.
Terms in these criteria, in plain language(6)

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.

05

Study design

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

Study arms

  • Experimental
    SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection;

    Drug: SHR-1918/ SHR-1918 placebo

  • Experimental
    SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection;

    Drug: SHR-1918/ SHR-1918 placebo

Interventions

  • DrugSHR-1918/ SHR-1918 placebo

    SHR-1918/ SHR-1918 placebo Dose 1

  • DrugSHR-1918/ SHR-1918 placebo

    SHR-1918/ SHR-1918 placebo Dose 2

06

What researchers measure

Primary outcomes

  1. Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline

    Time frame: at 20 weeks and 24 weeks of treatment

Secondary outcomes

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

    Time frame: at 24 weeks of treatment

  2. Percentage change in LDL-C relative to baseline

    Time frame: at 24 weeks of treatment

  3. Percentage change in TC relative to baseline

    Time frame: at 24 weeks of treatment

  4. Percentage change in ApoB relative to baseline

    Time frame: at 24 weeks of treatment

  5. Percentage change in ApoA1 relative to baseline

    Time frame: at 24 weeks of treatment

  6. Change in TG relative to baseline

    Time frame: at 24 weeks of treatment

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

    Time frame: at 24 weeks of treatment

  8. Change in LDL-C relative to baseline

    Time frame: at 24 weeks of treatment

  9. Change in TC relative to baseline

    Time frame: at 24 weeks of treatment

  10. Change in ApoB relative to baseline

    Time frame: at 24 weeks of treatment

  11. Change in ApoA1 relative to baseline

    Time frame: at 24 weeks of treatment

  12. Change and percentage change in Lp(a) relative to baseline

    Time frame: at 24 weeks of treatment

  13. Change and percentage change in HDL-C relative to baseline

    Time frame: at 24 weeks of treatment

  14. Proportion of subjects with TG < 1.7 mmol/L

    Time frame: at 24 weeks and 48 weeks of treatment

  15. Change and percentage change in non-HDL-C relative to baseline

    Time frame: at 48 weeks of treatment

  16. Change and percentage change in LDL-C relative to baseline

    Time frame: at 48 weeks of treatment

  17. Change and percentage change in TC relative to baseline

    Time frame: at 48 weeks of treatment

  18. Change and percentage change in ApoB relative to baseline

    Time frame: at 48 weeks of treatment

  19. Change and percentage change in ApoA1 relative to baseline

    Time frame: at 48 weeks of treatment

  20. Change and percentage change in Lp(a) relative to baseline

    Time frame: at 48 weeks of treatment

  21. Change and percentage change in HDL-C relative to baseline

    Time frame: at 48 weeks of treatment

  22. Change and percentage change in TG relative to baseline

    Time frame: at 48 weeks of treatment

  23. Proportion of subjects who received rescue treatment

    Time frame: Approximately a year

  24. Incidence and severity of adverse events and injection site reactions

    Time frame: Approximately a year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 20, 2026
Start date
Apr 1, 2026→Mar 31, 2026
Oct 20, 2026
Primary completion
Nov 2027→Mar 2027
Oct 20, 2026
Study completion
Nov 2027→Oct 2027
Oct 20, 2026
Enrollment
360 (estimated)→367 (actual)
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Recruiting→Active, not recruiting
    Start date Apr 1, 2026→Mar 31, 2026
    Primary completion Nov 2027→Mar 2027
    Study completion Nov 2027→Oct 2027
    Enrollment 360 (estimated)→367 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07349615
Responsible party
Sponsor
First posted
Jan 20, 2026
Start date
Mar 31, 2026
Primary completion
Mar 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Oct 20, 2026

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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