Early-phase Study of ART002g1 Injection in HeFH: Safety, Tolerability and Preliminary Efficacy
Starting soon · Early Phase 1
Conditions studied: Heterozygous Familial Hypercholesterolemia
In brief
This study is an open-label, single ascending dose (SAD) study designed to evaluate the safety and tolerability of ART002g1 in patients with heterozygous familial hypercholesterolemia (HeFH) who require further reduction in low-density lipoprotein cholesterol (LDL-C). ART002g1 uses base editing technology, which is designed to interfere with the expression of the PCSK9 gene in the liver, thereby reducing the circulating levels of PCSK9 and LDL-C. The primary objectives of this study are to determine the safety and pharmacodynamic (PD) profiles of ART002g1 in this patient population.
Key facts
- Study ID
- NCT07353398
- Run by
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- People needed
- 24
- Starts
- 2026-03-11
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-03-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Shanghai General Hospital — Shanghai, China
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.