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BMS-986036

Phase 2

Diabetes Mellitus Type 2 | Monoclonal antibody | Metabolic |Bristol-Myers Squibb Company|Last Updated: Jul 31, 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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment219
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02097277A Study to Evaluate BMS-986036 in Obese Adults With Type-2 DiabetesPHASE2 COMPLETED 219Apr 15, 2014May 17, 2016Jul 31, 201916 United States, Canada
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Study Endpoints
Primary Endpoints
Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12
Baseline (Day 1) and Week 12

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) from Baseline to Week 12 was reported.

Secondary Endpoints
Change in Body Weight From Baseline to Week 12
Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)
Baseline (Day 1) and Week 12
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Baseline (Day 1) and Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment A: Placebo (Matching with BMS-986036 - Daily)PLACEBO_COMPARATORPlacebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks
Arm 2: Treatment B: BMS-986036 (1 mg Daily)EXPERIMENTALBMS-986036 1 mg subcutaneous injection once daily for 12 weeks
Treatment C: BMS-986036 (5 mg Daily)EXPERIMENTALBMS-986036 5 mg subcutaneous injection once daily for 12 weeks
Treatment D: BMS-986036 (20 mg Daily)EXPERIMENTALBMS-986036 20 mg subcutaneous injection once daily for 12 weeks
Treatment E: BMS-986036 (20 mg Weekly)EXPERIMENTALBMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks Followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks
Interventions
NameTypeDescription
BMS-986036BIOLOGICAL -
Placebo (Matching with BMS-986036)BIOLOGICAL -
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites16

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0% * Body mass index 30.0 to 50.0 Exclusion Criteria: * Any significant acute or chronic medical il...

Countries:United StatesCanada
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