NCT07172646 A Study of SRSD216 in Patients With Elevated Lipoprotein (a)
| NCT ID | NCT07172646 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sirius Therapeutics Co., Ltd. |
| Condition | Hyperlipoproteinemia (a) |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 84 participants in total. It began in 2025-04-07 with a primary completion date of 2026-05.
⚠ 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
This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD216 and to identify a dose range for further studies in subjects with elevated Lp(a) level with or without ASCVD history.
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.
Contact & Investigator
Medical Director, MD
STUDY DIRECTOR
Sirius Therapeutics
Frequently Asked Questions
Who can join the NCT07172646 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hyperlipoproteinemia (a). 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 NCT07172646 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07172646 currently recruiting?
Yes, NCT07172646 is actively recruiting participants. Contact the research team at medical@siriusrna.com for enrollment information.
Where is the NCT07172646 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07172646 clinical trial?
NCT07172646 is sponsored by Sirius Therapeutics Co., Ltd.. The principal investigator is Medical Director, MD at Sirius Therapeutics. The trial plans to enroll 84 participants.