A Study of SRSD216 in Patients With Elevated Lipoprotein (a)

January 3, 2026 updated by: Sirius Therapeutics Co., Ltd.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SRSD216 injection (Part 1)
SRSD216 administered SC. in subjects of Part 1
Drug: SRSD216 injection
Administered SC.
Experimental: SRSD216 injection (Part 2)
SRSD216 administered SC. in subjects of Part 2
Drug: Placebo
Administered SC.
Drug: SRSD216 injection
Administered SC.
Experimental: 0.9% Sodium Chloride (Part 1)
Placbo administered SC. in subjects of Part 1
Drug: Placebo
Administered SC.
Placebo Comparator: 0.9% Sodium Chloride (Part 2)
Placbo administered SC. in subjects of Part 2
Drug: Placebo
Administered SC.
Drug: SRSD216 injection
Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: 1 year
A summary of TEAE to evaluate the safety and tolerability of SRSD216
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sirius Therapeutics Co., Ltd.

Investigators

  • Study Director: Medical Director, MD, Sirius Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

August 21, 2025

First Submitted That Met QC Criteria

September 10, 2025

First Posted (Estimated)

September 15, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRSD216-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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