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NCT04948008
Evaluate the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia
Phase 2, PHASE3 trial testing IBI306 in Familial Hypercholesterolemia - Homozygous in 8 participants. Status unknown.
15 July 2020
Quick facts
| Lead sponsor | Shenzhen People's Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 5 November 2019 |
| Primary completion | 15 July 2020 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- IBI306 — full drug profile →
Conditions studied
- Familial Hypercholesterolemia - Homozygous — all drugs for Familial Hypercholesterolemia - Homozygous →
- Lipid Metabolism Disorders — all drugs for Lipid Metabolism Disorders →
- Proprotein Convertase Subtilisin/Kexin 9 — all drugs for Proprotein Convertase Subtilisin/Kexin 9 →
Sponsor
Shenzhen People's Hospital
Who can join
Adults 18 to 80, any sex, with Familial Hypercholesterolemia - Homozygous or Lipid Metabolism Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
IBI306 is a bio-innovative drug against proprotein convertase subtilisin 9 (PCSK-9) monoclonal antibody. Currently, cholesterol-lowering drugs with multiple mechanisms of action are on the market or under development. Among them, anti-PCSK-9 monoclonal antibodies have received widespread attention due to their good safety and efficacy. The results of existing preclinical studies show that IBI306 has a clear structure, good stability, and is not inferior to other drugs of its kind in terms of drug activity, animal pharmacokinetics (PK)/pharmacodynamics (PD) and safety. This study is divided into two phases: the dose exploration phase (the first phase) and the confirmatory phase (the second phase). Each stage is divided into screening period, treatment period, and safety follow-up period. The first phase of this research is the randomized design of open labels. The second stage is an open, single-arm design. The main purpose of the first phase of the study: to evaluate the tolerability and safety of multiple-dose repeated administration of IBI306 in the Chinese population with hypercholesterolemia, and to recommend the dose for the second phase. The main purpose of the second phase of the study: to evaluate the effectiveness of IBI306 in the Chinese homozygous familial hypercholesterolemia population. Secondary research purpose: To evaluate the safety and immunogenicity of IBI306 in Chinese homozygous familial hypercholesterolemia population.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting proprotein convertase subtilisin/kexin type 9 (PCSK9): from bench to bedside.
Bao X, Liang Y, Chang H, Cai T, et al · · 2024 · cited 101× · PMID 38185721 · DOI 10.1038/s41392-023-01690-3 -
Application of next generation sequencing in cardiology: current and future precision medicine implications.
Papadopoulou E, Bouzarelou D, Tsaousis G, Papathanasiou A, et al · · 2023 · cited 6× · PMID 37424920 · DOI 10.3389/fcvm.2023.1202381
Verify or expand the search:
- PubMed search for NCT04948008
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IBI306
Trials testing the same drug.
- NCT07473960 — IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia · Phase 3 · recruiting
- NCT04709536 — A Study of IBI306 in Participants With Hypercholesterolemia · Phase 3 · completed
- NCT04179669 — Safety and Efficacy of IBI306 in HeFH Patients · Phase 3 · completed
- NCT04031742 — A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Famil · Phase 2, PHASE3 · completed
- NCT03815812 — Multiple Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Chinese Patients With Hypercholesterolemia · Phase 2 · completed
Other recruiting trials for Familial Hypercholesterolemia - Homozygous
Currently open trials in the same condition.
- NCT06597006 — Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterole · Phase 3 · recruiting
- NCT04370899 — Early Detection of Familial Hypercholesterolemia in Children · recruiting
Other Shenzhen People's Hospital trials
Trials by the same sponsor.
- NCT07512050 — Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity · NA · not yet recruiting
- NCT07366255 — Safety and Efficacy of Tripalmitoleoylglycerol in the Treatment of Dermatitis · NA · completed
- NCT07366229 — Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne · Phase 2 · recruiting
- NCT07266532 — Topical Lactobacillus Crispatus for Skin Barrier Dysfunction in Obesity · NA · completed
- NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · 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 NCT04948008 (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 Shenzhen People's Hospital
- Last refreshed: 1 July 2021
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/NCT04948008.
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