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MBX-102

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Gilead Sciences, Inc.|Trials Updated: Sep 18, 2026

MBX-102 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Jul 2006

MBX-102 target and mechanism

ModalitySmall molecule

Also known as Arhalofenate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials6
Total Enrollment870

FDA Designations

No designations recorded

MBX-102 clinical trials

MBX-102 · 6 trials · 3 indications

Phase 2 6
NCT02252835Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With GoutGout
COMPLETED32 Analytics
NCT02063997Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout PatientsGout
COMPLETED248 Analytics
NCT01416402Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout PatientsHyperuricemia
COMPLETED27 Analytics
NCT01399008Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout PatientsGout
COMPLETED100 Analytics
NCT01336686Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With GoutHyperuricemia
COMPLETED67 Analytics
NCT00353587Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on InsulinType 2 Diabetes
COMPLETED396 Analytics
PHASE2COMPLETED
Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout
GoutUnlock trial analytics
PHASE2COMPLETED
Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients
GoutUnlock trial analytics
PHASE2COMPLETED
Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients
HyperuricemiaUnlock trial analytics
PHASE2COMPLETED
Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients
GoutUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout
HyperuricemiaUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of patients achieving a target sUA < 6.0, < 5.0, < 4.0, and < 3.0 mg/dL on Day 29 after treatment with arhalofenate 800 mg and febuxostat 80 mg
Day 29
Proportion of patients achieving an sUA reduction of ≥ 2.0, ≥ 3.0, and ≥ 4.0 mg/dL from baseline on Day 29 after treatment with arhalofenate 800 mg and febuxostat 80 mg
Day 29
Absolute and percent reduction in sUA from baseline on Day 29 after treatment with arhalofenate 800 mg and febuxostat 80 mg
Day 29
AUC(0-t) of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Days 14, 28, and 42
AUC(0-tau) of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Days 14, 28, and 42
Tmax of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Days 14, 28, and 42
Cmax of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Days 14, 28, and 42
The incidence of flares (mean number of flares per patient) from baseline through Week 12 in the arhalofenate 800 mg group compared to the allopurinol 300 mg group.
12 weeks
Proportion of patients achieving sUA <6.0 mg/dL, <5.0 mg/dL, <4.0 mg/dL and <3.0 mg/dL at the end of combination treatment period with each of the doses of arhalofenate
36 days
Serum Uric Acid
Percent change from baseline in serum uric acid at Week 4

Percent change from baseline in serum uric acid in Per Protocol population

Evaluate effects of MBX-102 administered orally at doses of 200, 400 and 600 mg daily for 16 weeks, on glucose control, as measured by HbA1c
Evaluate safety of MBX-102 with particular emphasis on endpoints of weight gain and edema

Secondary Endpoints

Proportion of patients achieving a target sUA < 6.0, < 5.0, < 4.0, and < 3.0 mg/dL on Day 29 after treatment with arhalofenate 600 mg and febuxostat 40 mg
Day 29
Proportion of patients achieving an sUA reduction of ≥ 2.0, ≥ 3.0, and ≥ 4.0 mg/dL from baseline on Day 29 after treatment with arhalofenate 600 mg and febuxostat 40 mg
Day 29
Absolute and percent reduction in sUA from baseline on Day 29 after treatment with arhalofenate 600 mg and febuxostat 40 mg
Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arhalofenate with febuxostat (PK cohort)EXPERIMENTAL -
Arhalofenate with febuxostat (non-PK cohort)EXPERIMENTAL -
Arhalofenate 600 mgEXPERIMENTAL -
Arhalofenate 800 mgEXPERIMENTAL -
Allopurinol 300 mg; colchicine 0.6 mgACTIVE_COMPARATOR -
Allopurinol 300 mgACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Arhalofenate with febuxostat and colchicineOTHER -
Arhalofenate 400 mgEXPERIMENTALArhalofenate 400 mg plus allopurinol 300 mg
AllopurinolACTIVE_COMPARATORPlacebo plus Allopurinol 300 mg
MBX-102 200 mgEXPERIMENTALMBX-102 200 mg once daily for 16 weeks
MBX-102 400 mgEXPERIMENTALMBX-102 400 mg once daily for 16 weeks
MBX-102 600 mgEXPERIMENTALMBX-102 600 mg once daily for 16 weeks
Sugar PillPLACEBO_COMPARATORPlacebo comparator once daily for 16 weeks
ActosACTIVE_COMPARATORActos 30 mg once daily for 16 weeks

Interventions

NameTypeDescription
ArhalofenateDRUG800 mg once daily orally for four weeks
FebuxostatDRUG40 mg once daily orally for 1 week then up-titrated to 80 mg once daily orally for another three weeks
ColchicineDRUG0.6 mg daily
Arhalofenate 600 mgDRUGArhalofenate 600 mg tablets once daily for 12 weeks
Allopurinol 300 mgDRUGAllopurinol 300 mg tablets once daily for 12 weeks
Colchicine 0.6 mgDRUGColchicine 0.6 mg over-encapsulated tablets once daily for 12 weeks
PlaceboDRUGPlacebo tablets once daily for 12 weeks
Arhalofenate 800 mgDRUGArhalofenate 800 mg tablets once daily for 12 weeks
AllopurinolDRUGAllopurinol 300 mg as active comparator
Placebo comparatorDRUGMatching placebo once daily for 4 weeks
MBX-102DRUGMBX-102 200 mg once daily for 16 weeks
ActosDRUGActos 30 mg once daily for 16 weeks
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female patient, 18 to 75 years of age, inclusive * Known gout diagnosis (per criteria of the American Rheumatism Association) * Has an sUA ≥ 7.5 mg/dL * A female patient must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses f...

Countries:United StatesCanadaGeorgiaArgentinaIndiaIsrael
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Recent Changes (Last 90 Days)

MEDIUMOct 19, 2026NCT01336686TRIAL_REMOVED: changed
MEDIUMOct 19, 2026NCT02252835TRIAL_REMOVED: changed
MEDIUMOct 19, 2026NCT01336686TRIAL_REMOVED: changed
MEDIUMOct 19, 2026NCT02252835TRIAL_REMOVED: changed

Frequently asked questions about MBX-102

What is MBX-102 used for?

MBX-102 is a small molecule being developed for the treatment of Type 2 Diabetes. It is currently in Phase 2 clinical development and is being studied in patients whose blood sugar is not adequately controlled with insulin therapy.

What does MBX-102 target?

The specific molecular target of MBX-102 has not been disclosed. It is a small molecule therapeutic being developed for Type 2 Diabetes, but its mechanism of action is not publicly detailed in the available information.

Who makes MBX-102?

MBX-102 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes.

What phase is MBX-102 in?

MBX-102 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it is not yet approved by regulatory authorities. The drug remains investigational and is being studied for its potential use in Type 2 Diabetes.

What clinical trials is MBX-102 in?

MBX-102 has one completed clinical trial, identified as NCT00353587. This was a Phase 2, randomized, double-blind, placebo-controlled study that enrolled 396 participants with Type 2 Diabetes who were suboptimally controlled on insulin. The trial was conducted in the United States, Argentina, India, and Israel.

Is MBX-102 the same as Metaglidasen?

Yes, MBX-102 is also known as Metaglidasen. The clinical trial NCT00353587, which evaluated the drug in Type 2 Diabetes, refers to it as Metaglidasen. Both names refer to the same investigational small molecule being developed by Gilead Sciences.