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MK-8655

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Nov 13, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

MK-8655 · 1 trial · 1 indication

Phase 1 1
NCT01640873Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)Type 2 Diabetes
COMPLETED33 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With One or More Adverse Events
Up to 14 days after the last dose of study drug (Up to 31 days)

An adverse event 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 Discontinuing Study Drug Due to an Adverse Event
Up to 17 days

An adverse event 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.

Fasting Plasma Glucose (FPG)
Day 16 (Predose)

Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.

Secondary Endpoints

True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)
24 hours post dose on Days 1, 7, and 14
24-Hour Weighted Mean Glucose (WMG)
Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.
Change From Baseline at 2 Hours Oral Glucose Tolerance Test
Baseline and 2 hours after dosing on Days 1, 3, and 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-8655 80 mg/MK-8655 320 mgEXPERIMENTALParticipants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
PlaceboPLACEBO_COMPARATORParticipants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.

Interventions

NameTypeDescription
MK-8655DRUGParticipants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.
PlaceboDRUGParticipants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male or female of non-child bearing potential * Body Mass Index ≤40 kg/m\^2 * Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only * In good health except for T2DM * Willing to follow a standard diet * Nonsmoker and/or no use of ...

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Frequently asked questions about MK-8655

What is MK-8655 used for?

MK-8655 is an investigational small molecule being developed for the treatment of Type 2 Diabetes. It is a metabolic therapeutic that has been studied in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

What does MK-8655 target?

The molecular target of MK-8655 has not been disclosed. It is a small molecule being studied for its effects on Type 2 Diabetes, but the specific biological target is not publicly available.

Who makes MK-8655?

MK-8655 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical research on this investigational drug for Type 2 Diabetes.

What phase is MK-8655 in?

MK-8655 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is not yet available as a marketed therapy.

What clinical trials is MK-8655 in?

MK-8655 has one completed clinical trial, NCT01640873, which was a Phase 1 study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with Type 2 Diabetes. The trial enrolled 33 participants and was placebo-controlled, randomized, and double-blind.

Is MK-8655 the same as any other drug?

No alternative names for MK-8655 have been disclosed. It is identified solely by its development code MK-8655 in clinical trial records and by the developer, Merck & Company, Inc.