Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753606
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2021-02-09
Brief Title:
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
Sponsor:
NewAmsterdam Pharma
Organization:
NewAmsterdam Pharma
Study Overview
Official Title:
A Placebo-Controlled Double-Blind Randomized Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to High-Intensity Statin Therapy
Status:
COMPLETED
Status Verified Date:
2021-09
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:
ROSE
Brief Summary:
This study will be a placebo-controlled double-blind randomized phase 2 dose-finding study to evaluate the efficacy safety and tolerability of obicetrapib as an adjunct to high-intensity statin therapy
Detailed Description:
This study will be a placebo-controlled double-blind randomized phase 2 dose-finding study to evaluate the efficacy safety and tolerability of obicetrapib as an adjunct to high-intensity statin therapy The screening period for this study will take up to 2-weeks Afterwards patients will be randomized to placebo 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period After the treatment period patients will continue for a 4-week safety follow-up and a 15-week PK follow-up
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