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BMS-830216

Phase 1

Obesity | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: Nov 4, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment161

FDA Designations

No designations recorded

Clinical trial landscape

BMS-830216 · 2 trials · 1 indication

Phase 1 2
NCT00909766Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese SubjectsObesity
COMPLETED113 Analytics
NCT00878020Safety Study to Evaluate BMS-830216 in Healthy SubjectsObesity
COMPLETED48 Analytics
PHASE1COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
Obesity
NCT00909766113
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PHASE1COMPLETED
Safety Study to Evaluate BMS-830216 in Healthy Subjects
Obesity
NCT0087802048
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Study Endpoints

Primary Endpoints

Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests
Within 2 weeks after study drug administration
Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results
Within the 10 days after study drug administration

Secondary Endpoints

Pharmacokinetics: to assess the multiple-dose PK of BMS-830216
Within 2 weeks of study drug administration
Pharmacodynamics: to assess the pharmacodynamic effect of BMS-830216 on body weight and BMI over 4 weeks of therapy
Within 2 weeks of study drug administration
Pharmacokinetic profile (drug absorption, distribution, metabolism and excretion process) determined by plasma concentration vs. time profile from a series of plasma samples up to 10 days post dose
Within the 10 days after study drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Panel AACTIVE_COMPARATOR -
Panel BACTIVE_COMPARATOR -
Panel CACTIVE_COMPARATOR -
Panel DACTIVE_COMPARATOR -
Panel EACTIVE_COMPARATOR -
Panel FACTIVE_COMPARATORLow Dose
Panel GACTIVE_COMPARATORHigh Dose
Panel HPLACEBO_COMPARATOR -
Arm 1ACTIVE_COMPARATORBMS-830216 (10 mg)
Arm 2ACTIVE_COMPARATORBMS-830216 (30 mg)
Arm 3ACTIVE_COMPARATORBMS-830216 (100 mg)
Arm 4ACTIVE_COMPARATORBMS-830216 (300 mg)
Arm 5ACTIVE_COMPARATORBMS-830216 (600 mg)
Arm 6ACTIVE_COMPARATORBMS-830216 (1200 mg)

Interventions

NameTypeDescription
BMS-830216DRUGCapsules, Oral, 30 mg, once daily, 28 days
PlaceboDRUGCapsules, Oral, 0 mg, once daily, 28 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Obese subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Body Mass Index (BMI) of 30 to 40 kg/m², inclusive * Women who are not of childbearing potential (ie, who ar...

Countries:United States
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Competitive Landscape -Obesity 186 trials

Top 20 of 32 competitors

CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN8PHASE3Maridebart cafraglutide
Eli Lilly and CompanyLLY38PHASE3Orforglipron
Novo Nordisk A/S Sponsored ADR Class BNVO45PHASE3Cagrilintide, Semaglutide
Rhythm Pharmaceuticals, Inc.RYTM6PHASE3Setmelanotide
Regeneron Pharmaceuticals, Inc.REGN3PHASE3Mibavademab
Pfizer Inc.PFE1PHASE3PF-08653944
Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
Kailera Therapeutics, Inc.KLRA4PHASE3Ribupatide
AstraZeneca PLCAZN3PHASE2AZD6234
PfizerMTSR3PHASE3MET097
Structure Therapeutics, Inc. Sponsored ADRGPCR2PHASE2Undisclosed
Biohaven Ltd.BHVN1PHASE2Taldefgrobep Alfa
Skye Bioscience, Inc.SKYE1PHASE2Nimacimab, semaglutide
Palatin Technologies, Inc.PTN1PHASE2bremelanotide, tirzepatide
Arrowhead Pharmaceuticals, Inc.ARWR2PHASE1ARO-INHBE, Tirzepatide
Veru IncVERU1PHASE2Enobosarm, Semaglutide weekly
Alnylam Pharmaceuticals, IncALNY1PHASE1ALN-2232, Tirzepatide
Gilead Sciences, Inc.GILD1PHASE1GS-4571, Omeprazole
AbbVie, Inc.ABBV1PHASE1ABBV-295
MBX Biosciences, Inc.MBX1PHASE1MBX 4291
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Frequently asked questions about BMS-830216

What is BMS-830216 used for?

BMS-830216 is an investigational small molecule being developed for obesity. It is a metabolic therapeutic that has been evaluated in Phase 1 clinical trials in the United States. The drug is not approved and remains in clinical development.

Who makes BMS-830216?

BMS-830216 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company has sponsored Phase 1 clinical trials of the drug in the United States.

What phase is BMS-830216 in?

BMS-830216 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 161 participants enrolled. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BMS-830216 in?

BMS-830216 has been studied in two completed Phase 1 trials: NCT00878020, a safety study in healthy subjects with 48 participants, and NCT00909766, a safety, pharmacokinetics and pharmacodynamics study in obese subjects with 113 participants. Both trials were conducted in the United States.

Is BMS-830216 the same as any other drug?

No alternative names for BMS-830216 have been reported. The drug is identified solely by its development code BMS-830216 in clinical trial records.