enlicitide decanoate (MK-0616) / Merck (MSD), UCB - LARVOL DELTA

From lead to market: chemical approaches to transform peptides into therapeutics. (PubMed, Trends Biochem Sci) - "In this review, we explore two recent therapeutic candidates (semaglutide, a peptide hormone analogue, and MK-0616, an mRNA display-derived candidate) as case studies that highlight general approaches to improving pharmacokinetics (PK) and potency. We also emphasize the critical link between advances in medicinal chemistry and the optimisation of highly efficacious peptide therapeutics."

Journal • Review

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 (clinicaltrials.gov) - P3 | N=301 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Jul 2025 ➔ Feb 2025 | Trial completion date: Sep 2025 ➔ Apr 2025

Trial completion date • Trial primary completion date • Dyslipidemia • Metabolic Disorders

A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034) (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033) (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010) (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034) (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

Emerging oral therapeutic strategies for inhibiting PCSK9. (PubMed, Atheroscler Plus) - "Subcutaneous administration of monoclonal antibodies (evolocumab and alirocumab) every 2 or 4 weeks determined a 60 % reduction of LDL cholesterol levels, while the GalNac-siRNA anti PCSK9 (inclisiran) provided an effective lipid lowering activity (-50 %) after an initial subcutaneous dose, repeated after 3 months and followed by a maintenance dose every 6 months. These problems could be overcome by the development of small chemical molecules anti PCSK9 as oral therapy for controlling hypercholesterolemia. In the present review, we summarized the pharmacological properties of oral anti PCSK9 molecules that are currently under clinical development (DC371739, CVI-LM001, and AZD0780), including the mimetic peptides enlicitide decanoate (MK-0616) and NNC0385-0434."

Journal • Review • Cardiovascular • Dyslipidemia • Metabolic Disorders

A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027) (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026) (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034) (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

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 (clinicaltrials.gov) - P3 | N=300 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Metabolic Disorders

A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034) (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032) (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Renal Disease

A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025) (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023) (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033) (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031) (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024) (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022) (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016) (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012) (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Dyslipidemia • Metabolic Disorders

A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033) (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031) (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031) (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032) (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Renal Disease