A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral SAL0137 in Adults With Elevated Lp(a) and Increased Risk of Cardiovascular Events

NCT07729475 | Not Yet Recruiting Phase 2

• 1 other identifier: SAL0137A201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled Phase II trial evaluating the efficacy and safety of oral SAL0137 in adults with elevated Lp(a) and high cardiovascular risk. Participants will be randomized 1:1:1:1 to receive low-dose SAL0137, medium-dose SAL0137, high-dose SAL0137, or placebo for a treatment period of 12 weeks. The study assesses changes in Lp(a) levels and safety parameters.

Conditions

Elevated Lipoprotein(a)

Keywords

SAL0137; Elevated Lipoprotein(a); Phase II; Atherosclerotic Cardiovascular Disease (ASCVD)

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Lipoprotein (a) Lp(a)

  Baseline to Week 12

Study Arms (4)

Test Group 1

EXPERIMENTAL

Drug: SAL0137 Dose 1

Test Group 2

EXPERIMENTAL

Drug: SAL0137 Dose 2

Test Group 3

EXPERIMENTAL

Drug: SAL0137 Dose 3

Reference Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SAL0137 Dose 1 DRUG

SAL0137 Tablets

Test Group 1

SAL0137 Dose 2 DRUG

SAL0137 Tablets

Test Group 2

SAL0137 Dose 3 DRUG

SAL0137 Tablets

Test Group 3

Placebo DRUG

Placebo

Reference Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years on the date of signing the informed consent form, male or female;
• Body mass index (BMI) within the range of 18.5 to 40.0 kg/m² (inclusive);
• Participants must be at elevated risk for cardiovascular events;
• Lp(a) ≥ 150 nmol/L (or ≥ 60 mg/dL) at screening or prior to randomization;
• Participants receiving the following medications at screening must have been on a stable regimen for the specified duration prior to screening and prior to randomization, and are expected to remain on a stable regimen throughout the study
• Compliance with study drug administration during the run-in period prior to randomization must be between 80% and 120%;
• Participants (including their partners) must be willing to voluntarily adopt highly effective contraceptive measures from the time of signing the informed consent form until 3 months after the last dose of study drug (see Appendix 2); female participants of childbearing potential must have a negative pregnancy test (serum) and must not be breastfeeding;
• Fully understand the objectives and requirements of this study, voluntarily participate in the clinical trial and sign the written informed consent form, and be willing and able to comply with the visit, treatment, and examination procedures specified in the protocol.

You may not qualify if:

• Experienced any of the following within 3 months prior to screening or prior to randomization: myocardial infarction or unstable angina, stroke or transient ischemic attack, acute limb ischemia, hemorrhagic stroke or other major bleeding history, major cardiac or non-cardiac surgery, coronary, carotid, or peripheral artery revascularization; or other events that, in the investigator's opinion, indicate clinical instability;
• Planned cardiac, cerebrovascular, or peripheral artery surgery, or coronary revascularization, or other major surgery after randomization;
• Active malignancy, or history of malignancy within 5 years prior to screening (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that have been radically resected);
• Previous history of diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.;
• History of acute kidney injury within 12 months prior to screening;
• Uncontrolled hyperthyroidism or hypothyroidism;
• Uncontrolled type 1 or type 2 diabetes mellitus within 6 months prior to screening (including diabetic ketoacidosis or hyperglycemic hyperosmolar state, or HbA1c \> 8.5% at screening);
• Active infection requiring systemic anti-infective therapy (oral or intravenous) prior to randomization, and the infection has not clinically resolved or still requires continued anti-infective treatment prior to randomization;
• New York Heart Association (NYHA) Class III or IV cardiac function prior to screening;
• Lipoprotein apheresis within 3 months prior to screening, or planned during the study period;
• Use of weight-loss medications (see Appendix 3) or undergone surgery causing weight instability within 2 months prior to screening;
• Long-term continuous or repeated use of systemic glucocorticoids within 3 months prior to screening;
• Known allergy to the active ingredient or any excipients of SAL0137;
• Uncontrolled hypertension at screening or prior to randomization (office sitting systolic blood pressure ≥ 160 mmHg and/or office sitting diastolic blood pressure ≥ 100 mmHg);
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² at screening or prior to randomization (calculated using the CKD-EPI 2021 formula, see Appendix 4), or undergoing dialysis;

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Li

CONTACT

13521531013; 13521531013@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

CN (1)