Last reviewed · How we verify
NCT06816264
A Study of HRS-5346 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
Phase 2 trial testing HRS-5346 in Treatment of Lipoprotein Disorder in 120 participants. Completed in 29 September 2025.
29 September 2025
Quick facts
| Lead sponsor | Shandong Suncadia Medicine Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 18 February 2025 |
| Primary completion | 29 September 2025 |
| Estimated completion | 29 September 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- HRS-5346 — full drug profile →
- Placebo
Conditions studied
- Treatment of Lipoprotein Disorder — all drugs for Treatment of Lipoprotein Disorder →
Sponsor
Shandong Suncadia Medicine Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Treatment of Lipoprotein Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main purpose of this study is to evaluate the efficacy and safety of HRS-5346 in adult participants with elevated Lp(a) at high risk for cardiovascular events.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Emerging pharmacological strategies in lipoprotein(a) reduction.
Mansoor T, Ismayl M, Parikh S, Nambi V, et al · · 2025 · PMID 40821459 · DOI 10.1080/08998280.2025.2524791
Verify or expand the search:
- PubMed search for NCT06816264
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Shandong Suncadia Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07272330 — A Phase I Trial on the Relative Bioavailability and Food Effect of HRS-1893 Tablets in Healthy Subjects · Phase 1 · completed
- NCT07269756 — A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese · Phase 1 · completed
- NCT07229560 — A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants · Phase 1 · completed
- NCT07097831 — A Clinical Trial of HRS-1301 on the Pharmacokinetics of Rosuvastatin Calcium Tablets in Healthy Subjects · Phase 1 · completed
- NCT06961643 — Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function · 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 NCT06816264 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shandong Suncadia Medicine Co., Ltd.
- Last refreshed: 17 November 2025
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/NCT06816264.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing