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Muraglitazar

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Bristol-Myers Squibb Company|Trials Updated: Apr 27, 2012

Muraglitazar development status

Highest phase Phase 3
Registered trials 9 across 1 sponsor since Nov 2004

Muraglitazar target and mechanism

Molecular targetPPARG, PPARA
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials9
Total Enrollment7,392

FDA Designations

No designations recorded

Muraglitazar clinical trials

Muraglitazar · 9 trials · 8 indications

Phase 3 7Phase 2 2
NCT00106808Study of Muraglitazar Versus Pioglitazone in Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED1,440 Analytics
NCT00094991Mechanism of Action and Efficacy of Muraglitazar in Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED42 Analytics
NCT00095030Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin AloneDiabetes Mellitus, Type 2
COMPLETED1,752 Analytics
NCT00240370A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 DiabeticsType 2 Diabetes
COMPLETED1,159 Analytics
NCT00162175PPAR-COMBO With SulfonylureaMetabolics Diabetes Nos
COMPLETED534 Analytics
NCT00162240PPAR - Combination With MetforminDiabetes Mellitus
COMPLETED534 Analytics
NCT00246987A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic ControlDiabetes, Type 2
COMPLETED341 Analytics
PHASE3COMPLETED
Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes
Type 2 Diabetes MellitusUnlock trial analytics
PHASE3COMPLETED
Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE3COMPLETED
Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE3COMPLETED
A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics
Type 2 DiabetesUnlock trial analytics
PHASE3COMPLETED
PPAR-COMBO With Sulfonylurea
Metabolics Diabetes NosUnlock trial analytics
PHASE3COMPLETED
PPAR - Combination With Metformin
Diabetes MellitusUnlock trial analytics
PHASE3COMPLETED
A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Diabetes, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in HBA1c from baseline to Week 24
The change from baseline in insulin medicated glucose disposal after 16 weeks of treatment with Muraglitazar
Change in baseline HbA1c after 52 weeks
Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin
Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide
compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin
To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2
To compare at a .05 level of significance, after 6 weeks of oral administration of double-blind treatment the percent change from baseline to average triglycerides (TG), week 5-6 between 5, 10 and 20 mg

Secondary Endpoints

Change for baseline in TG and HDL-C at Week 24
Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
MuraglitazarDRUG -
PioglitazoneDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites195

Inclusion Criteria: * Type 2 Diabetes * HbA1c \> = 8.0% and \< = 12.0% * Serum triglyceride concentration \< = 600 mg/dL * Fasting c-peptide \> = 1.0 ng/ml * Body mass index \< = 41 kg/m2 * Drug naive patients Exclusion Criteria: * History of MI (myocardial infarction), coronary angioplasty or by...

Countries:United StatesArgentinaAustraliaBrazilCanadaChileIndiaMexicoPeruPhilippinesRussiaTaiwanThailandUkraineItalyAustriaGermanyHong KongPolandPuerto RicoSwitzerlandFranceNetherlandsSpainUnited KingdomSouth KoreaSwedenCzechiaSouth Africa
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Frequently asked questions about Muraglitazar

What is Muraglitazar?

Muraglitazar is an investigational oral small molecule developed by Bristol-Myers Squibb for type 2 diabetes and dyslipidemia. It was studied as a dual PPAR agonist, a single agent designed to act on both PPARG and PPARA. It is not an approved medicine; all of its clinical trials have been completed.

What does Muraglitazar target?

Muraglitazar targets PPARG and PPARA, two nuclear receptors that regulate glucose and lipid metabolism. It acts as an agonist at both receptors, which is why it is described as a dual PPAR agonist. This dual activity was studied for effects on glycemic control and lipid levels in people with type 2 diabetes and dyslipidemia.

Who makes Muraglitazar?

Muraglitazar was developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The compound also appears in the literature and trial records under the code name BMS-298585. Bristol-Myers Squibb sponsored the clinical program evaluating it in type 2 diabetes and dyslipidemia.

What phase is Muraglitazar in?

Muraglitazar reached Phase 3 clinical development. It is investigational and has not been approved for any indication. Three completed trials are listed, including two Phase 3 studies and two Phase 2 studies, with a combined enrollment of 3,234 participants. No trials are currently active.

What clinical trials is Muraglitazar in?

Completed trials include NCT00246987, a Phase 3 monotherapy study in type 2 diabetes with 341 participants, and NCT00240370, a Phase 3 study combining Muraglitazar or pioglitazone with metformin in 1,159 participants. Phase 2 studies were NCT00245388 in mixed dyslipidemia and NCT00240383, a dose-ranging monotherapy trial in type 2 diabetes.

Is Muraglitazar the same as BMS-298585?

Yes. Muraglitazar is the same compound as BMS-298585, the internal Bristol-Myers Squibb code used in its clinical trial titles. Records for the monotherapy Phase 3 trial in type 2 diabetes and the Phase 2 dyslipidemia trial refer to the drug as BMS-298585, while other studies use the name Muraglitazar.