Recent Updates
Recently added Catalysts

BMS-823778

Phase 2

Dyslipidemia | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Trials Updated: Oct 12, 2015

BMS-823778 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Apr 2010

BMS-823778 target and mechanism

Molecular targetHSD11B1
Target classInhibitor
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment162

FDA Designations

No designations recorded

BMS-823778 clinical trials

BMS-823778 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT01111955Safety Study of BMS-823778 in Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED62 Analytics
NCT01112423Safety Study of BMS-823778 in Subjects With HypercholesterolemiaDyslipidemia
COMPLETED60 Analytics
PHASE2COMPLETED
Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE2COMPLETED
Safety Study of BMS-823778 in Subjects With Hypercholesterolemia
DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline
Within 28 days following dosing
Lowering of LDL-C
Within 28 days following dosing
Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Up to Day 21

Secondary Endpoints

Pharmacokinetics (measuring trough concentrations)
On days 7, 14 and 28
Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)
Within 28 days following dosing
Pharmacodynamic effects of BMS-823778 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG)
Within 28 days following dosing
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-823778 (2 mg)ACTIVE_COMPARATOR\+ metformin
BMS-823778 (10 mg)ACTIVE_COMPARATOR\+ metformin
BMS-823778 (20 mg)ACTIVE_COMPARATOR\+ metformin
PlaceboPLACEBO_COMPARATOR\+ metformin
Panel 1: BMS-823778 or Placebo matching BMS-823778EXPERIMENTALHealthy Subjects
Panel 2: BMS-823778 or Placebo matching BMS-823778EXPERIMENTALHealthy Subjects
Panel 3: BMS-823778 or Placebo matching BMS-823778EXPERIMENTALHealthy Subjects
Panel 4: BMS-823778 or Placebo matching BMS-823778EXPERIMENTALSubjects with T2DM
Panel 5: BMS-823778 or Placebo matching BMS-823778EXPERIMENTALSubjects with T2DM

Interventions

NameTypeDescription
BMS-823778DRUGCapsules, Oral, 2 mg, once daily, 28 days
PlaceboDRUGCapsules, Oral, 0 mg, once daily, 28 days
MetforminDRUGCapsules, Oral, ≥ 1500 mg, once daily, 28 days
Placebo matching with BMS-823778DRUGCapsules, Oral, 0 mg, Once daily, 14 days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Type 2 diabetes mellitus * Drug naive or on stable metformin therapy * HbA1c 7-10% * FPG ≤ 240mg/dL Exclusion Criteria: * History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack,...

Countries:United StatesAustraliaCanadaJapan
Unlock Eligibility Criteria

Frequently asked questions about BMS-823778

What is BMS-823778 used for?

BMS-823778 is an investigational small molecule being studied for dyslipidemia and Type 2 Diabetes Mellitus. It has been evaluated in clinical trials involving patients with hypercholesterolemia and Type 2 Diabetes, as well as healthy volunteers. It is not approved for any indication and remains in clinical development.

What does BMS-823778 target?

BMS-823778 targets HSD11B1, also known as 11-beta-hydroxysteroid dehydrogenase type 1. It acts as an inhibitor of this enzyme. By inhibiting HSD11B1, the drug is designed to modulate cortisol metabolism, which is being explored for effects on lipid levels and glucose control in dyslipidemia and Type 2 Diabetes Mellitus.

Who is developing BMS-823778?

BMS-823778 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company has sponsored the clinical trials evaluating the drug in dyslipidemia and Type 2 Diabetes Mellitus.

What phase is BMS-823778 in?

BMS-823778 is in Phase 2 clinical development. It has completed two Phase 2 trials and one Phase 1 trial. The drug is investigational and has not been approved by the FDA or any other regulatory agency for dyslipidemia or Type 2 Diabetes Mellitus.

What clinical trials is BMS-823778 in?

BMS-823778 has been studied in completed trials including NCT01112423, a Phase 2 safety study in subjects with hypercholesterolemia, and NCT01111955, a Phase 2 safety study in subjects with Type 2 Diabetes. A Japanese Phase 1 multiple ascending dose study, NCT01515202, was also completed. No trials are currently active.