NCT07230730 A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
| NCT ID | NCT07230730 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Suncadia Pharmaceuticals Co., Ltd |
| Condition | Hyperlipidemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 900 participants in total. It began in 2026-01-13 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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≥ 1.7 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07230730 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hyperlipidemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07230730 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 900 participants.
Is NCT07230730 currently recruiting?
Yes, NCT07230730 is actively recruiting participants. Contact the research team at Sheng.qi@hengrui.com for enrollment information.
Where is the NCT07230730 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07230730 clinical trial?
NCT07230730 is sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. The trial plans to enroll 900 participants.