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NCT07421284
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy
Phase 3 trial testing SYH2053/placebo injection in Non-familial Hypercholesterolemia and Mixed Hyperlipidemia in 900 participants. Not yet recruiting.
31 December 2027
Quick facts
| Lead sponsor | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 900 |
| Start date | 31 March 2026 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 January 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- SYH2053/placebo injection — full drug profile →
Conditions studied
- Non-familial Hypercholesterolemia and Mixed Hyperlipidemia — all drugs for Non-familial Hypercholesterolemia and Mixed Hyperlipidemia →
Sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Non-familial Hypercholesterolemia and Mixed Hyperlipidemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy. This trial plans to enroll 900 Participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07421284
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SYH2053/placebo injection
Trials testing the same drug.
- NCT07421232 — A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and M · Phase 2 · completed
Other recruiting trials for Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
Currently open trials in the same condition.
- NCT07421297 — A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholes · Phase 3 · recruiting
Other CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. trials
Trials by the same sponsor.
- NCT07465263 — A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) · Phase 3 · not yet recruiting
- NCT07421297 — A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholes · Phase 3 · recruiting
- NCT07241910 — A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2061 · Phase 1 · not yet recruiting
- NCT07241923 — A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2070 Inj · Phase 1 · recruiting
- NCT07096869 — Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Pa · Phase 1 · recruiting
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 NCT07421284 (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 CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Last refreshed: 19 February 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/NCT07421284.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing