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MK-8666

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Sep 10, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

MK-8666 · 1 trial · 1 indication

Phase 1 1
NCT01971554Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)Type 2 Diabetes Mellitus
COMPLETED63 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Fasting Plasma Glucose (FPG) at Day 15
Predose (Baseline) and 24 h postdose Day 14 (Day 15)

Blood glucose was measured on a fasting basis (collected after an 8-hour fast). Blood was collected on Day -1 (pre-planned dose), predose on Days 1, 3, 7, and 14, and 24h postdose Day 14 (Day 15). The baseline measurement was computed as the average of the Day -1 and predose Day 1 measurements. FPG is expressed as mg/dL. This change from baseline reflects values for Day 15 FPG minus Day 0 FPG values.

Number of Participants Who Experienced at Least Once Adverse Event
Up to 28 days

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Number of Participants Who Discontinued Study Drug Due to an AE
Up to 14 days

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Secondary Endpoints

Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h)
Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose
Maximum Plasma Drug Concentration After Dosing (Cmax)
Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose
Time to Reach Cmax (Tmax)
Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-8666 50 mgEXPERIMENTALMK-8666, 50 mg, oral, once a day (QD) for Days 1 to 14.
MK-8666 150 mgEXPERIMENTALMK-8666, 150 mg, oral, QD, for Days 1 to 14
MK-8666 500 mgEXPERIMENTALMK-8666, 500 mg, oral, QD for Days 1 to 14
PlaceboPLACEBO_COMPARATORPlacebo, oral, QD for Days 1 to 14

Interventions

NameTypeDescription
MK-8666DRUGMK-8666, capsules, oral, QD, Days 1 to 14
PlaceboDRUGPlacebo, capsules, oral, QD, Days 1 to 14
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * If female, must be either postmenopausal or surgically sterile * A Body Mass Index (BMI) ≥18 kg/m\^2 to ≤40 kg/m\^2, inclusive. * A diagnosis of T2DM * Drug naïve or is being treated with no more than 2 oral antihyperglycemic agents (thiazolidenediones are excluded) * Judged t...

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Frequently asked questions about MK-8666

What is MK-8666 used for?

MK-8666 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy.

Who makes MK-8666?

MK-8666 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is in Phase 1 clinical development for Type 2 Diabetes Mellitus.

What phase is MK-8666 in?

MK-8666 is in Phase 1 clinical development. It is an investigational drug for Type 2 Diabetes Mellitus and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug is not currently in any active trials.

What clinical trials is MK-8666 in?

MK-8666 has been studied in one completed Phase 1 clinical trial, identified as NCT01971554. This trial evaluated the safety, tolerability, pharmacodynamics, and pharmacokinetics of MK-8666 in participants with Type 2 Diabetes Mellitus. The trial enrolled 63 participants and was randomized, double-blind, and placebo-controlled.

Is MK-8666 the same as any other drug?

No alternative names for MK-8666 have been disclosed. The drug is identified by its development code MK-8666 and is being studied under the clinical trial identifier NCT01971554 for Type 2 Diabetes Mellitus.