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MBX-2044

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Gilead Sciences, Inc.|Last Updated: May 1, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

MBX-2044 · 1 trial · 1 indication

Phase 2 1
NCT00422487Safety and Tolerability Study of MBX-2044 in Patients With Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED60 Analytics
PHASE2COMPLETED
Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days
Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema
Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MBX-2044 1.5 mgEXPERIMENTAL -
MBX-2044 4.5 mgEXPERIMENTAL -
MBX-2044 15 mgEXPERIMENTAL -
MBX-2044 30 mgEXPERIMENTAL -
MBX-2044 60 mgEXPERIMENTAL -
MBX-2044 90 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
MBX-2044DRUGMBX-2044 1.5 mg one capsule daily for 14 days
Placebo for MBX-2044DRUGPlacebo Intervention
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 2 diabetes previously controlled with up to one or two non-TZD hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., Prandin®, Starlix®), metformin (e.g., Glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol...

Countries:United States
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Frequently asked questions about MBX-2044

What is MBX-2044 used for?

MBX-2044 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 2 clinical development and has been studied in a completed clinical trial in patients with Type 2 Diabetes Mellitus.

Who makes MBX-2044?

MBX-2044 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is currently in Phase 2 clinical development for Type 2 Diabetes Mellitus.

What phase is MBX-2044 in?

MBX-2044 is in Phase 2 clinical development. It has completed one Phase 2 clinical trial, and no active trials are currently listed for the drug. It remains an investigational drug and has not been approved by regulatory authorities.

What clinical trials is MBX-2044 in?

MBX-2044 has one completed clinical trial, NCT00422487, titled "Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes." This was a Phase 2, randomized, double-blind, placebo-controlled study conducted in the United States with 60 participants.

Is MBX-2044 FDA approved?

MBX-2044 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The drug has completed one clinical trial but has not yet received regulatory approval.