A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023)

NCT06699329 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-023MK-0616-023
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate and semaglutide alone or at the same time. Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Semaglutide is a drug used to treat type 2 diabetes. Researchers want to learn what happens to the amount of semaglutide and enlicitide decanoate in a person's blood when each drug is taken alone and when they are taken together.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate

  Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.

  At designated timepoints (up to 24 hours postdose)

• Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Semaglutide

  Blood samples will be collected to determine the AUC0-24hrs of semaglutide.

  At designated timepoints (up to 24 hours postdose)

• Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate

  Blood samples will be collected to determine the Cmax of enlicitide decanoate.

  At designated timepoints (up to approximately 2 weeks postdose)

• Maximum Plasma Concentration (Cmax) of Semaglutide

  Blood samples will be collected to determine the Cmax of semaglutide.

  At designated timepoints (up to approximately 2 weeks postdose)

• Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate

  Blood samples will be collected to determine the Tmax of enlicitide decanoate.

  At designated timepoints (up to approximately 2 weeks postdose)

• Time to Maximum Plasma Concentration (Tmax) of Semaglutide

  Blood samples will be collected to determine the Tmax of semaglutide.

  At designated timepoints (up to approximately 2 weeks postdose)

Secondary Outcomes (2)

• Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 12 weeks

• Number of Participants Who Discontinue Study Due to a TEAE

  Up to approximately 12 weeks

Study Arms (1)

Enlicitide Decanoate and Semaglutide

EXPERIMENTAL

Period 1: Participants receive an oral dose of enlicitide decanoate every day for 1 week. Period 2: Participants receive an oral dose of semaglutide every day for 6 weeks. Period 3: Participants receive an oral dose of both enlicitide decanoate and semaglutide every day for 1 week.

Drug: Enlicitide Decanoate; Drug: Semaglutide

Interventions

Enlicitide Decanoate DRUG

multiple doses, oral tablet

Also known as: MK-0616

Enlicitide Decanoate and Semaglutide

Semaglutide DRUG

multiple doses, oral tablet

Also known as: Rybelsus

Enlicitide Decanoate and Semaglutide

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2
• Medically healthy with no clinically significant medical history

You may not qualify if:

• History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
• History of cancer

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

MK-0616; semaglutide

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: January 22, 2024
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)