Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450366
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate MK-0616 Oral PCSK9 Inhibitor Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia MK-0616-018 CORALreef AddOn
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The main purpose of this study is to assess whether enlicitide decanoate is superior to ezetimibe or bempedoic acid or ezetimibe bempedoic acid in reducing LDL-C in participants with hypercholesterolemia and to evaluate its safety and tolerability The primary study hypotheses are enlicitide decanoate is superior to ezetimibe bempedoic acid and ezetimibe bempedoic acid on mean percent change from baseline in LDL-C at week 8
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 |
|---|---|---|---|
| U1111-1290-3888 | OTHER | UTN | None |
| MK-0616-018 | OTHER | None | None |
| 2023-504920-25 | REGISTRY | None | None |