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MK-1092, 4.0 nmol/kg

Phase 1

Type 1 Diabetes Mellitus | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Nov 15, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03170544Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001)PHASE1 COMPLETED 69Aug 16, 2017Nov 8, 2018Nov 15, 20191 United States
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Study Endpoints
Primary Endpoints
Number of Participants Who Experienced an Adverse Event (AE)
Up to 112 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. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.

Number of Participants Who Discontinued the Study Due to an AE
Up to 58 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. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.

GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 1 Diabetes Mellitus (T1DM) (Part 3)
Up to approximately 24 hours post-dose

The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (\~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and the same treatment (same dose of glargine) received.

Secondary Endpoints
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)
Up to approximately 24 hours post-dose
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 2 Diabetes Mellitus (T2DM) (Part 4)
Up to approximately 24 hours post-dose
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)
Up to approximately 24 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1, MK-1092, 4.0 nmol/kgEXPERIMENTALMK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Part 1, MK-1092, 8.0 nmol/kgEXPERIMENTALMK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Part 1, MK-1092, 16 nmol/kgEXPERIMENTALMK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Part 1, MK-1092, 32 nmol/kgEXPERIMENTALMK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Part 1, MK-1092, 64 nmol/kgEXPERIMENTALMK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Part 1, Glargine, 3.0 nmol/kgACTIVE_COMPARATORGlargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Part 2, MK-1092, 8.0 nmol/kg + lispro, 1.2 nmol/kgEXPERIMENTALMK-1092, 8.0 nmol/kg dose selection based on Part 1 + lispro (Humalog®), 1.2 nmol/kg, as a single dose, in healthy participants
Part 3, MK-1092, 8.0 nmol/kgEXPERIMENTALMK-1092, (8.0 nmol/kg based on Part 1), SC, in participants with T1DM.
Part 3, MK-1092, 32 nmol/kgEXPERIMENTALMK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
Part 3, Glargine, 3.0 nmol/kgACTIVE_COMPARATORGlargine, 3.0 nmol/kg, SC, as a single dose, in participants with T1DM
Part 4, MK-1092, 32 nmol/kgEXPERIMENTALMK-1092, 32 nmol/kg, SC, as a single dose, in participants with T2DM
Part 4, MK-1092, 16 nmol/kgEXPERIMENTALMK-1092, 16 nmol/kg, SC, as a single dose, in participants with T2DM
Part 4, MK-1092, 64 nmol/kgEXPERIMENTALMK-1092, 64 nmol/kg, SC, as a single dose, in participants with T2DM
Part 4, Glargine, 3.0 nmol/kgACTIVE_COMPARATORGlargine, 3.0 nmol/kg, SC, as a single dose, in participants with T2DM
Interventions
NameTypeDescription
MK-1092, 4.0 nmol/kgDRUGMK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
MK-1092, 8.0 nmol/kgDRUGMK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
MK-1092, 16 nmol/kgDRUGMK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
MK-1092, 32 nmol/kgDRUGMK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
MK-1092, 64 nmol/kgDRUGMK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Glargine 3.0 nmol/kgDRUGGlargine 3.0 nmol/kg, SC, as a single dose
Lispro 1.2 nmol/kgDRUGLispro (Humalog®), 1.2 nmol/kg, IV infusion SC over 3 hours as a single dose starting \~12 hours after MK-1092 administration.
Placebo to glargineDRUGPlacebo to glargine, SC, as a single dose
Placebo to MK-1092DRUGPlacebo to MK-1092, SC, as a single dose
DextroseOTHER20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
InsulinBIOLOGICALParticipants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Subject Inclusion Criteria All participants * Be a healthy male, or healthy female participant (excluding diabetes mellitus in Part 3 participants) of non-child bearing potential. A female non-child bearing potential is one who is postmenopausal without menses for at least 1 year or whose status i...

Countries:United States
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