A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)

NCT06655311 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-012MK-0616-012
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. The researchers want to learn about the safety of enlicitide chloride when administered at high doses.

Conditions

Healthy; Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

  Up to approximately 56 days

• Number of Participants Who Discontinue Study Treatment Due to an AE

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

  Up to approximately 42 days

Secondary Outcomes (6)

• Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride

  At designated timepoints (up to approximately 24 hours)

• Maximum Plasma Concentration (Cmax) of Enlicitide Chloride

  At designated timepoints (up to approximately 1 week)

• Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride

  At designated timepoints (up to approximately 1 week)

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

  At designated timepoints (up to approximately 1 week)

• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride

  At designated timepoints (up to approximately 1 week)

Study Arms (2)

Enlicitide Chloride

EXPERIMENTAL

Participants receive enlicitide chloride titrated orally from Dose 1, Dose 2, or Dose 3 once daily (QD) over the course of a 14-day treatment for each dose based on the safety and tolerability of the previous starting dose. The total treatment duration is up to approximately 6 weeks.

Biological: Enlicitide Chloride

Placebo

PLACEBO COMPARATOR

Participants receive placebo orally for up to approximately 6 weeks.

Other: Placebo

Interventions

Enlicitide Chloride BIOLOGICAL

Oral administration

Also known as: MK-0616

Enlicitide Chloride

Placebo OTHER

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
• Has a body mass index (BMI)≥18 and ≤32 kg/m\^2

You may not qualify if:

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Altasciences Clinical Kansas, Inc. (Site 0002)

Overland Park, Kansas, 66212, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

MK-0616

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: September 30, 2022
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)