SHR-1918 to lower LDL cholesterol and triglycerides in adults with hyperlipidemia

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

This trial tests whether SHR-1918 can further lower LDL cholesterol and triglycerides in adults with hyperlipidemia who are already on a stable statin dose.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07230730 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized, placebo-controlled trial compares SHR-1918 with matching placebo in adults with hyperlipidemia on stable statin therapy. Eligible participants meet LDL-C thresholds based on ASCVD risk category and have fasting triglycerides between 2.3 and 5.6 mmol/L; they receive study drug or placebo and undergo regular lipid measurements. Safety monitoring includes liver enzymes and thyroid function, and participants with poorly controlled hypertension or significant liver enzyme elevations are excluded. The trial is being conducted at The Second Affiliated Hospital Zhejiang University School of Medicine in Hangzhou and requires informed consent and on-site visits.

Who should consider this trial

Good fit: Adults aged 18 or older with hyperlipidemia who are on a stable statin dose, have LDL-C above risk-specific thresholds, and fasting triglycerides between 2.3 and 5.6 mmol/L are the intended participants.

Not a fit: Patients with poorly controlled hypertension, marked liver enzyme elevations, low TSH, triglycerides outside the required range, or those unable to attend the single trial site are unlikely to be eligible or benefit from participation.

Why it matters

Potential benefit: If successful, SHR-1918 could offer an additional option to lower both LDL cholesterol and triglycerides for patients already taking statins.

How similar studies have performed: Other lipid-lowering drug classes have demonstrated reductions in LDL-C and triglycerides in prior trials, but SHR-1918 represents a distinct investigational agent and large-scale phase 3 data are still limited.

Eligibility criteria

Inclusion Criteria:

1. the age must be at least 18 years old, and both men and women are eligible;
2. the patient was receiving a stable dose of statins at the time of screening,, and the fasting LDL-C met: For individuals with extremely high risk of ASCVD, LDL-C≥1.4 mmol/L; for those with very high risk of ASCVD, LDL-C≥1.8 mmol/L; and for those with medium and high risk of ASCVD, ≥2.6 mol/L;
3. Fasting TG≥2.3，and ≤5.6 mmol/L;
4. Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person；

Exclusion Criteria:

1. poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization；
2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) \> 3× upper limit of normal (ULN), or total bilirubin \> 2×ULN；
3. Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN；
4. The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m2；
5. Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Sheng Qi

Conditions Hyperlipidemia