A Phase 3 interventional study of SHR-1918 and SHR-1918 placebo in Hyperlipidemia, sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment
The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.
861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.
This study's planned enrollment of 900 is above the median of 88 across 735 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →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.
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.
Exclusion Criteria:
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SHR-1918
Drug: SHR-1918 placebo
Drug: SHR-1918
Drug: SHR-1918 placebo
SHR-1918
SHR-1918 placebo
The percentage change of serum LDL-C from baseline
Time frame: Baseline and Week 24
The percentage change in serum TG from baseline
Time frame: Baseline and Week 24
Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline
Time frame: Baseline and Week 24
The percentage change in serum total cholesterol (TC) from baseline
Time frame: Baseline and Week 24
The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24
Time frame: Baseline and Week 24
The percentage change of serum apolipoprotein A1 (ApoA1) from baseline
Time frame: Baseline and Week 24
The change from baseline in serum LDL-C
Time frame: Baseline and Week 24
The change from baseline in serum TG
Time frame: Baseline and Week 24
The change from baseline in serum non-HDL-C
Time frame: Baseline and Week 24
The change from baseline in serum TC
Time frame: Baseline and Week 24
The change from baseline in serum ApoB
Time frame: Baseline and Week 24
The change from baseline in serum ApoA1
Time frame: Baseline and Week 24
Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a))
Time frame: Baseline and Week 24
Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C)
Time frame: Baseline and Week 24
LDL-C goal attainment rates at Week 24, overall and by risk subgroup
Time frame: Baseline and Week 24
Absolute and percentage change from baseline in serum non-HDL-C at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum ApoB at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum Lp(a) at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum TC at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum TG at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum HDL-C at Week 48
Time frame: Baseline and Week 48
Absolute and percentage change from baseline in serum ApoA1 at Week 48
Time frame: Baseline and Week 48
LDL-C goal attainment rates at Week 48, overall and by risk subgroup
Time frame: Baseline and Week 48
The incidence and severity of adverse events (AEs) throughout the study
Time frame: up to week 52
Injection site reactions (pain, pruritus, erythema, swelling, induration, and rash) throughout the study
Time frame: up to week 52
Major adverse cardiovascular events (Cardiovascular death, Non-fatal myocardial infarction, Non-fatal stroke and Coronary revascularization) throughout the study
Time frame: up to week 52
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Oct 2027, 21 months after the start.
Of 51 industry-sponsored phase 3 interventional studies under Hyperlipidemias, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 21 months is above that.
Counting every sponsor, half of 57 studies reached it within 18 months; a quarter within 11 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: SHR-1918
Beijing Suncadia Pharmaceuticals Co., Ltd →