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MBX-2044

Phase 2

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

MBX-2044 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2007

MBX-2044 target and mechanism

Molecular targetPPARG
Target classModulator
ModalitySmall molecule

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

MBX-2044 clinical trials

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 studied for the treatment of Type 2 Diabetes Mellitus. It has been evaluated in a Phase 2 clinical trial in adults with the condition. It is not approved for any indication and remains in clinical development.

What does MBX-2044 target?

MBX-2044 targets PPARG, also known as peroxisome proliferator-activated receptor gamma. It is classified as a modulator of this target. PPARG is a nuclear receptor involved in regulating glucose and lipid metabolism, which is relevant to Type 2 Diabetes Mellitus.

Who is developing MBX-2044?

MBX-2044 is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. The company is the sponsor of the clinical program evaluating the compound in Type 2 Diabetes Mellitus.

What phase is MBX-2044 in?

MBX-2044 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is MBX-2044 in?

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