NCT07295418CompletedPhase 3
A Study of SAL003 in Participants With Hypercholesterolemia and Mixed Dyslipidemia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Safety and Efficacy of SAL003 Monotherapy in Participants With Hypercholesterolemia and Mixed Dyslipidemia
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
This is a Phase 3 study to evaluate the efficacy and safety of SAL003, a fully human monoclonal antibody against PCSK9, as monotherapy in Chinese participants with hypercholesterolemia and mixed dyslipidemia. Participants who are not on lipid-lowering therapy or have washed out from previous therapy will be randomized in a 2:1 ratio to receive either SAL003 140 mg or matching placebo, administered subcutaneously every 4 weeks for 12 weeks. Following the double-blind period, all participants will enter an open-label extension period and receive SAL003 140 mg Q4W for an additional 40 weeks. The primary objective is to demonstrate the superiority of SAL003 over placebo in reducing Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 618 (actual)
- First submitted
- 7 Dec 2025
- Start date
- 23 Oct 2023
- Primary completion date
- 22 Apr 2025
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07295418
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 618
- From 23 Oct 2023 to the primary completion date, 22 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any lipid-lowering drugs (statins, ezetimibe, etc.) or traditional Chinese medicines known to affect lipid metabolism within 3 months prior to screening.
- Prior treatment with any PCSK9 inhibitor.
- Known hypersensitivity to any component of the investigational product or history of severe allergy to antibody therapies.
Other illness
- History of atherosclerotic cardiovascular disease (ASCVD).
- Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg).
- Significant hepatic or renal impairment.
- Active liver disease or positive for HIV or Syphilis.
- History of malignancy within 5 years prior to screening.
- Any other condition deemed by the investigator to be unsuitable for participation.
Lab values
- Type 1 diabetes or poorly controlled Type 2 diabetes (HbA1c \>8.0%).
Other
- Diagnosis of familial hypercholesterolemia (HoFH or HeFH).
Who the study is looking for
- Male or female, aged 18 to 75 years (inclusive).
- Fasting LDL-C ≥2.6 mmol/L and \<4.9 mmol/L at screening/randomization.
- Meets criteria based on the 2023 Chinese Lipid Management Guidelines (e.g., specific LDL-C levels with certain risk factors, or presence of diabetes).
- Fasting triglycerides (TG) ≤5.6 mmol/L at screening/randomization.
- Provides written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.