SRSD216 for people with high lipoprotein(a)

A Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose-Escalation and -Expansion Study to Evaluate the Safety, Tolerability, PK, and PD of Subcutaneously Administered SRSD216 in Patients With Elevated Lipoprotein(a)

This study will test a single subcutaneous injection of SRSD216 versus placebo in adults with elevated lipoprotein(a) to see if it's safe, tolerated, and how the body processes it.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sirius Therapeutics Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07172646 on ClinicalTrials.gov

What this trial studies

This is a two-part, randomized, placebo-controlled Phase 1/2 study that gives a single subcutaneous dose of SRSD216 to adults with elevated Lp(a). It will monitor safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after dosing and identify dose ranges for later studies. The study may enroll participants with or without a history of atherosclerotic cardiovascular disease. All dosing and follow-up visits are conducted at the listed study site in Beijing.

Who should consider this trial

Good fit: Adults with elevated Lp(a) (with or without prior ASCVD), BMI 18–40 kg/m2, who meet safety criteria (no active cancer or bleeding disorders), can consent, and can attend the Beijing study site.

Not a fit: People with active or recent cancer, known bleeding or clotting disorders, or those who cannot travel to or attend the Beijing site are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, SRSD216 could become a new option to lower elevated Lp(a) and potentially reduce associated cardiovascular risk.

How similar studies have performed: Other investigational Lp(a)-lowering agents, including antisense oligonucleotides and siRNA therapies, have produced large reductions in Lp(a) in early trials, though definitive outcome benefits remain unproven.

Eligibility criteria

Inclusion Criteria:

* Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions;
* Males or females, of any race;
* Body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive;
* Male subjects are not allowed to donate sperm, and female subjects are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up.

Exclusion Criteria:

* Any history or evidence of abnormal bleeding or coagulopathy; or evidence of prolonged or unexplained, clinically significant bleeding, or frequent unexplained bruising or thrombosis; or history of spontaneous bleeding;
* Evidence of active or suspected cancer within 3 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative intent, or other in situ carcinoma that does not require systemic therapy and is considered cured for at least 1 years is allowed);
* Acute febrile illness within 7 days prior to dose administration or evidence of active infection;
* Any major surgery within 3 months prior to screening or plan to have any major surgery during the study;
* History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator;
* Fasting TG≥ 500 mg/dL (5.6 mmol/L) during screening;
* Receipt of an investigational drug within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study;
* Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.

Where this trial is running

Beijing, Beijing Municipality

• Site 01 — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Medical Director

Conditions Hyperlipoproteinemia