Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496243
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Impact of Obicetrapib and Obicetrapib Plus Repatha on Lpa Levels
Sponsor:
NewAmsterdam Pharma
Organization:
NewAmsterdam Pharma
Study Overview
Official Title:
A Phase 2 Study to Evaluate the Effect of Obicetrapib Alone and in Combination With Evolocumab Repatha on Lipoprotein a in Patients With Mild Dyslipidemia The VINCENT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VINCENT
Brief Summary:
The goal of this open label 16 week trial is to evaluate Lpa levels for patients with elevated Lpa being treated with obicetrapib and obiceptrapibevolocumab
Patients will
Have baseline Lpa tested at randomization Take 10mgdL obiceptrapib daily for 8 weeks and have Lpa tested at Week 8 Take 10 mgdL obicetrapib dailyevolocumab 140 every other week for 8 weeks and have Lpa retested at Week 16
Patients will
Have baseline Lpa tested at randomization Take 10mgdL obiceptrapib daily for 8 weeks and have Lpa tested at Week 8 Take 10 mgdL obicetrapib dailyevolocumab 140 every other week for 8 weeks and have Lpa retested at Week 16
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None