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NCT07172646
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)
Phase 1/Phase 2 trial testing SRSD216 injection in Hyperlipoproteinemia (a) in 84 participants. Currently enrolling.
1 May 2026
Quick facts
| Lead sponsor | Sirius Therapeutics Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 7 April 2025 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 April 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- SRSD216 injection — full drug profile →
- Placebo
Conditions studied
- Hyperlipoproteinemia (a) — all drugs for Hyperlipoproteinemia (a) →
Sponsor
Sirius Therapeutics Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Hyperlipoproteinemia (a). Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 1 year
A summary of TEAE to evaluate the safety and tolerability of SRSD216
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07172646
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hyperlipoproteinemia (a)
Currently open trials in the same condition.
- NCT05900141 — An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) · Phase 3 · active not recruiting
Other Sirius Therapeutics Co., Ltd. trials
Trials by the same sponsor.
- NCT07140523 — A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA · Phase 2 · recruiting
- NCT06116617 — A Phase 1 Study to Evaluate the Safety, Tolerability, PK/PD of SRSD107 in Healthy Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07172646 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sirius Therapeutics Co., Ltd.
- Last refreshed: 3 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07172646.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing