NCT07172646

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
11mo left

Started Apr 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Apr 2025Apr 2027

Study Start

First participant enrolled

April 7, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

August 21, 2025

Last Update Submit

January 3, 2026

Conditions

Hyperlipoproteinemia (a)

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events (TEAEs)

    A summary of TEAE to evaluate the safety and tolerability of SRSD216

    1 year

Study Arms (4)

SRSD216 injection (Part 1)

EXPERIMENTAL

SRSD216 administered SC. in subjects of Part 1

Drug: SRSD216 injection

SRSD216 injection (Part 2)

EXPERIMENTAL

SRSD216 administered SC. in subjects of Part 2

Drug: SRSD216 injectionDrug: Placebo

0.9% Sodium Chloride (Part 1)

EXPERIMENTAL

Placbo administered SC. in subjects of Part 1

Drug: Placebo

0.9% Sodium Chloride (Part 2)

PLACEBO COMPARATOR

Placbo administered SC. in subjects of Part 2

Drug: SRSD216 injectionDrug: Placebo

Interventions

PlaceboDRUG

Administered SC.

0.9% Sodium Chloride (Part 1)0.9% Sodium Chloride (Part 2)SRSD216 injection (Part 2)
SRSD216 injectionDRUG

Administered SC.

0.9% Sodium Chloride (Part 2)SRSD216 injection (Part 1)SRSD216 injection (Part 2)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 01

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Hyperlipoproteinemias

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Director, MD

    Sirius Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Medical Director

CONTACT

+86 21 61207756medical@siriusrna.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2025

First Posted

September 15, 2025

Study Start

April 7, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

CN(1)