Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008756
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-08-17
Brief Title:
Enlicitide Decanoate MK-0616 Oral PCSK9 Inhibitor Cardiovascular Outcomes Study MK-0616-015 CORALreef Outcomes
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Phase 3 Randomized Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This is a phase 3 randomized placebo-controlled study of the efficacy and safety of enlicitide decanoate an oral proprotein convertase subtilisinkexin type 9 PCSK9 inhibitor in participants with high cardiovascular risk The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events MACE including coronary heart disease CHD death ischemic stroke myocardial infarction MI acute limb ischemia or major amputation or urgent arterial revascularization
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT2071230064 | REGISTRY | None | None |
| 2022-502781-24 | OTHER | EU CT | None |