Drugs / Enlicitide Decanoate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LIPFENDRA | — | 2026-07-15 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06625814 | Jul → Aug 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06772792 | Apr → Jun 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06772779 | Apr → Jun 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06691906 | Mar → May 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06699329 | Jan → May 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06699355 | Nov → Dec 2023 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06658652 | Oct → Dec 2023 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT05934292 | Jul 2023 → Jan 2024 | hyperlipidemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06592339 | Oct → Dec 2022 | hyperlipoproteinemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07058077 | Aug 2025 → Dec 2033 expected | familial hypercholesterolemia | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT06492291 | Aug 2024 → Oct 2028 expected | — | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06008756 | Oct 2023 → Nov 2029 expected | arteriosclerosis disorder, hyperlipidemia | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05952856 | Aug 2023 → Jul 2025 | familial hypercholesterolemia | Merck Sharp & Dohme LLC | Completed | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-04-16 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USAが開発中の経口PCSK9阻害剤enlicitide decanoate、スタチンによるバックグラウンド治療中に追加することで、ガイドライン推奨の経口非スタチン系薬物療法と比較して、8週時のLDL-Cを有意に低下 msd.co.jp ↗
本試験において、enlicitideの投与により、8週時（56日目）における低密度リポ蛋白コレステロール（LDL-C）は、ベムペド酸、エゼチミブ、または両剤併用と比較して、統計学的に有意かつ臨床的に意味のある低下が示されました。 |
| 2026-03-30 | Merck Sharp & Dohme LLC | Results MSD’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins msd.com ↗
In the study, treatment with enlicitide resulted in statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to bempedoic acid, ezetimibe or bempedoic acid with ezetimibe at eight weeks (day 56) of treatment. |
| 2026-03-30 | Merck Sharp & Dohme LLC | Results Merck’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins merck.com ↗
In the study, treatment with enlicitide resulted in statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to bempedoic acid, ezetimibe or bempedoic acid with ezetimibe at eight weeks (day 56) of treatment. |
| 2026-03-16 | Merck Sharp & Dohme LLC | Results Merck Highlights New Data from Cardio-Pulmonary Pipeline at ACC.26 Showcasing Commitment to Advance Innovative Research merck.com ↗
Positive results from the Phase 3 CORALreef AddOn trial evaluating the efficacy and safety of enlicitide |
| 2025-11-26 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USAが開発中の経口PCSK9阻害剤enlicitide decanoate、第3相CORALreef HeFH試験で、家族性高コレステロール血症ヘテロ接合体（HeFH）を有する成人患者さんにおいてLDL-Cを有意に低下 msd.co.jp ↗
この試験では、家族性高コレステロール血症ヘテロ接合体（HeFH）を有する成人患者さんにおいて、24週時の低密度リポ蛋白コレステロール（LDL-C）がプラセボと比較して59.4%低下（95% CI: -65.6, -53.2; p<0.001）し、統計学的に有意かつ臨床的に意味のある改善を示しました。 |
| 2025-11-26 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USAが開発中の経口PCSK9阻害剤enlicitide decanoate、第3相CORALreef Lipids試験でLDL-Cを有意に低下 msd.co.jp ↗
この試験では、24週時における低密度リポ蛋白コレステロール（LDL-C）がプラセボと比較して主要解析では55.8%（95% CI: – 60.9, – 50.7; p< 0.001）、事後再解析では59.7%（95% CI: -62.3, -57.1）低下し、統計学的に有意かつ臨床的に意味のある改善を示しました。 |
| 2025-11-09 | Merck Sharp & Dohme LLC | Results MSD’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Adults with Heterozygous Familial Hypercholesterolemia (HeFH) in Phase 3 CORALreef HeFH Trial msd.com ↗ |
| 2025-11-09 | Merck Sharp & Dohme LLC | Results Merck’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Adults with Heterozygous Familial Hypercholesterolemia (HeFH) in Phase 3 CORALreef HeFH Trial merck.com ↗
The effect size and safety profile was comparable to that observed in the pivotal Phase 3 CORALreef Lipids study. |
| 2025-11-08 | Merck Sharp & Dohme LLC | Results MSD’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Phase 3 CORALreef Lipids Trial msd.com ↗
Enlicitide demonstrated statistically significant reductions in secondary endpoints including non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB) and lipoprotein(a) (Lp(a)) at week 24. |
| 2025-11-08 | Merck Sharp & Dohme LLC | Results Merck’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Phase 3 CORALreef Lipids Trial merck.com ↗
Enlicitide demonstrated statistically significant reductions in secondary endpoints including non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB) and lipoprotein(a) (Lp(a)) at week 24. |
| 2025-10-30 | Merck Sharp & Dohme LLC | Results Merck & Co., Inc., Rahway, N.J., USA Announces Third-Quarter 2025 Financial Results merck.com ↗
Announced Positive Topline Results From Third Phase 3 CORALreef Lipids Trial of Enlicitide Decanoate for Treatment of Adults With Hypercholesterolemia |
| 2025-09-02 | Merck Sharp & Dohme LLC | Results Merck’s Investigational Oral PCSK9 Inhibitor Enlicitide Decanoate Met All Primary and Key Secondary Endpoints in Adults with Hypercholesterolemia in Pivotal CORALreef Lipids Study merck.com ↗
The CORALreef Lipids trial successfully met all primary and key secondary endpoints. |
| 2025-07-29 | Merck Sharp & Dohme LLC | Results Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2025 Financial Results msd.com ↗
Announced Positive Topline Results From First Two Phase 3 CORALreef Trials of Enlicitide Decanoate for Treatment of Adults With Hyperlipidemia |
| 2025-07-29 | Merck Sharp & Dohme LLC | Results Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2025 Financial Results merck.com ↗
Announced Positive Topline Results From First Two Phase 3 CORALreef Trials of Enlicitide Decanoate for Treatment of Adults With Hyperlipidemia |
| 2025-06-09 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Topline Results From the First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia merck.com ↗
The CORALreef HeFH and CORALreef AddOn trials successfully met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) for enlicitide compared to placebo (CORALreef HeFH) and compared to other oral non-statin therapies (CORALreef AddOn). |
| 2023-03-06 | Merck Sharp & Dohme LLC | Results MSD’s MK-0616, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Patients with Hypercholesterolemia in Phase 2b Study msd.com ↗
MK-0616 was generally well tolerated and reduced LDL-C across all dose levels compared to placebo |
| 2023-03-06 | Merck Sharp & Dohme LLC | Results Merck’s MK-0616, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Patients with Hypercholesterolemia in Phase 2b Study merck.com ↗
MK-0616 was generally well tolerated and reduced LDL-C across all dose levels compared to placebo |
All press releases naming this drug 22 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enlicitide Decanoate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07058077 ↗ |
| Known as | MK-0616 | “Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor)” NCT05934292 ↗ |
| Action | Inhibit | “PCSK9 Inhibitor” NCT05934292 ↗ |
| Route | Oral | “single dose orally” NCT05934292 ↗ |
| Target | PCSK9 | “oral PCSK9 inhibitor enlicitide” PMID 41879224 ↗ Feb 2026 |