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
- Are there results?
- Not yet: the study is under way
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.
Show all 10Show fewer
- 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.
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07349615
- Acronym / sponsor ID
- SHR-1918-305
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
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.
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 |
|---|---|---|
| SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection； | Experimental | Drug: SHR-1918/ SHR-1918 placebo |
| SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection； | Experimental | Drug: SHR-1918/ SHR-1918 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 Dose 1 | Drug | SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection； |
| SHR-1918/ SHR-1918 placeboSHR-1918/ SHR-1918 placebo Dose 2 | Drug | SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection； |
Primary outcome
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
24 secondary outcomes
Percentage change in non-HDL-C relative to baseline
Time frame: at 24 weeks of treatment
Percentage change in LDL-C relative to baseline
Time frame: at 24 weeks of treatment
Percentage change in TC relative to baseline
Time frame: at 24 weeks of treatment
Percentage change in ApoB relative to baseline
Time frame: at 24 weeks of treatment
Percentage change in ApoA1 relative to baseline
Time frame: at 24 weeks of treatment
Change in TG relative to baseline
Time frame: at 24 weeks of treatment
Change in non-HDL-C relative to baseline
Time frame: at 24 weeks of treatment
Change in LDL-C relative to baseline
Time frame: at 24 weeks of treatment
Change in TC relative to baseline
Time frame: at 24 weeks of treatment
Change in ApoB relative to baseline
Time frame: at 24 weeks of treatment
Change in ApoA1 relative to baseline
Time frame: at 24 weeks of treatment
Change and percentage change in Lp(a) relative to baseline
Time frame: at 24 weeks of treatment
Change and percentage change in HDL-C relative to baseline
Time frame: at 24 weeks of treatment
Proportion of subjects with TG < 1.7 mmol/L
Time frame: at 24 weeks and 48 weeks of treatment
Change and percentage change in non-HDL-C relative to baseline
Time frame: at 48 weeks of treatment
Change and percentage change in LDL-C relative to baseline
Time frame: at 48 weeks of treatment
Change and percentage change in TC relative to baseline
Time frame: at 48 weeks of treatment
Change and percentage change in ApoB relative to baseline
Time frame: at 48 weeks of treatment
Change and percentage change in ApoA1 relative to baseline
Time frame: at 48 weeks of treatment
Change and percentage change in Lp(a) relative to baseline
Time frame: at 48 weeks of treatment
Change and percentage change in HDL-C relative to baseline
Time frame: at 48 weeks of treatment
Change and percentage change in TG relative to baseline
Time frame: at 48 weeks of treatment
Proportion of subjects who received rescue treatment
Time frame: Approximately a year
Incidence and severity of adverse events and injection site reactions
Time frame: Approximately a year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- 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 3 study of Hypertriglyceridemia, 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 4 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.