HypertriglyceridemiaPhase 3NCT07349615
A Study of SHR-1918 In Participants With Hypertriglyceridemia
A Phase 3 study of Hypertriglyceridemia, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 367 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to Oct 2027
- Phase
- Phase 3
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
- Male and female ≥ 18 years old, who is able and willing to provide a written informed consent.
- 1.7 ≤ TG ≤ 5.6 mmol/L.
- LDL-C < 3.4 mmol/L.
- Male and female subjects of childbearing potential 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 contraceptive methods as specified in the protocol.
Who cannot join
- History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
- Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
- Have a history of pancreatitis prior to screening or randomization.
- Acute ischemic ASCVD events within 3 months prior to screening or randomization.
- Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
- Malignant tumors within 5 years.
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- 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.
- 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.
- Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
- Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypertriglyceridemia
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.
- Conditions
- Hypertriglyceridemia
- Being tested
- SHR-1918/ SHR-1918 placebo
- Medical subject headings
- Hypertriglyceridemia
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 Dose 1
SHR-1918/ SHR-1918 placeboDrug
SHR-1918/ SHR-1918 placebo Dose 2
| Study group | Role | What they receive |
|---|---|---|
| SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection； | Experimental | Not described Receives: Drug: SHR-1918/ SHR-1918 placebo |
| SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection； | 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.
Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline
Measured: at 20 weeks and 24 weeks of treatment
Secondary outcomes (24)
Percentage change in non-HDL-C relative to baseline
Measured: at 24 weeks of treatment
Percentage change in LDL-C relative to baseline
Measured: at 24 weeks of treatment
Percentage change in TC relative to baseline
Measured: at 24 weeks of treatment
Percentage change in ApoB relative to baseline
Measured: at 24 weeks of treatment
Percentage change in ApoA1 relative to baseline
Measured: at 24 weeks of treatment
Change in TG relative to baseline
Measured: at 24 weeks of treatment
Change in non-HDL-C relative to baseline
Measured: at 24 weeks of treatment
Change in LDL-C relative to baseline
Measured: at 24 weeks of treatment
Change in TC relative to baseline
Measured: at 24 weeks of treatment
Change in ApoB relative to baseline
Measured: at 24 weeks of treatment
Change in ApoA1 relative to baseline
Measured: at 24 weeks of treatment
Change and percentage change in Lp(a) relative to baseline
Measured: at 24 weeks of treatment
Change and percentage change in HDL-C relative to baseline
Measured: at 24 weeks of treatment
Proportion of subjects with TG < 1.7 mmol/L
Measured: at 24 weeks and 48 weeks of treatment
Change and percentage change in non-HDL-C relative to baseline
Measured: at 48 weeks of treatment
Change and percentage change in LDL-C relative to baseline
Measured: at 48 weeks of treatment
Change and percentage change in TC relative to baseline
Measured: at 48 weeks of treatment
Change and percentage change in ApoB relative to baseline
Measured: at 48 weeks of treatment
Change and percentage change in ApoA1 relative to baseline
Measured: at 48 weeks of treatment
Change and percentage change in Lp(a) relative to baseline
Measured: at 48 weeks of treatment
Change and percentage change in HDL-C relative to baseline
Measured: at 48 weeks of treatment
Change and percentage change in TG relative to baseline
Measured: at 48 weeks of treatment
Proportion of subjects who received rescue treatment
Measured: Approximately a year
Incidence and severity of adverse events and injection site reactions
Measured: Approximately a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start31 Mar 2026
- Primary completionMar 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 HypertriglyceridemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 367 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
- NCT07349615
- Sponsor's protocol ID
- SHR-1918-305
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided