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PF-04856883

Phase 1

Diabetes Mellitus | Monoclonal antibody | Metabolic |Pfizer, Inc.|Last Updated: Feb 9, 2018

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01301456Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult FemalesPHASE1 COMPLETED 84Mar 1, 2011Apr 1, 2012Feb 9, 20187 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.

Number of Participants With Clinically Significant Physical Examination Findings
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.

Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (\>=) 25 percent (%) increase when baseline greater than (\>)200 milliseconds (msec); or increase \>=50% when baseline less than or equal to (\<=200) msec; 2) QRS interval: \>=25% increase when baseline \>100 msec; \>=50% increase when baseline \<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - \<480 msec, 480 - \<500 msec \>=500; absolute change 30 - \<60, \>=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.

Number of Participants With Vital Sign Abnormalities
Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50

Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (\<) 40 beats per minute (bpm) or greater than (\>) 120 bpm, standing/supine systolic pulse \< 40 bpm or \> 140 bpm, systolic blood pressure of \>=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure \<90 mmHg, diastolic blood pressure \>=20 mmHg change from baseline and diastolic blood pressure \<50 mm Hg.

Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) \<0.8\*lower limit of the reference range (LLRR); leukocytes \<0.6\*LLRR or \>1.5\*ULRR; platelet count \<0.5\*LLRR or \>1.75\*upper limit of the reference range (ULRR); total neutrophils (absolute \[abs\]), lymphocytes (abs) \<0.8\*LLRR or \>1.2\*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) \>1.2\*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin \>1.5\*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3\*ULRR, albumin, total protein \<0.8\*LLRR or \>1.2\*ULRR; blood urea nitrogen (BUN), creatinine \>1.3\*ULRR; glucose (fasting) \<0.6\*LLRR or \>1.5\*ULRR; uric acid \>1.2\* ULRR; sodium \<0.95\*LLRR or \>1.05\*ULRR; potassium, chloride, bicarbonate, calcium \<0.9\*LLRR or \>1.1\*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =\>20/ high-power field (HPF).

Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Arm 1 (Stage 1A)PLACEBO_COMPARATOR -
Treatment Arm 2 (Stage 1A)EXPERIMENTAL -
Treatment Arm 3 (Stage 1A)EXPERIMENTAL -
Treatment Arm 4 (Stage 1A)EXPERIMENTAL -
Treatment Arm 5 (Stage 1B)PLACEBO_COMPARATOR -
Treatment Arm 6 (Stage 1B)EXPERIMENTAL -
Treatment Arm 7 (Stage 1B)EXPERIMENTAL -
Treatment Arm 8 (Stage 1B)EXPERIMENTAL -
Treatment Arm 9 (Stage 2)PLACEBO_COMPARATOR -
Treatment Arm 10 (Stage 2)EXPERIMENTAL -
Treatment Arm 11 (Stage 2)EXPERIMENTAL -
Treatment Arm 12 (Stage 2)EXPERIMENTAL -
Treatment Arm 13 (Stage 2)EXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboBIOLOGICALSingle subcutaneous injection of placebo
PF-04856883BIOLOGICALSingle subcutaneous injection of PF-04856883
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Eligibility Criteria
Age Range18 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * History of Type 2 diabetes and currently being treated with high dose metformin * BMI between 22.0 and 40.0 kg/m2 * HbA1c between 7.0-10.0% * Fasting C-peptide \>1.21 ng/mL Exclusion Criteria: * History of clinically significant chronic conditions other than Type 2 diabetes ...

Countries:United States
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