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CVX-096

Phase 1

Diabetes Mellitus, Type 2 | Monoclonal antibody | Metabolic |Pfizer, Inc.|Last Updated: Apr 18, 2017

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment114
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00886821A Safety and Pharmacokinetic Study of CVX-096 in Type 2 DiabeticsPHASE1 COMPLETED 114 — — Oct 1, 2008Jun 1, 2011Apr 18, 20172 United States
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Study Endpoints
Primary Endpoints
Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1
pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1

AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1
Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8
pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22
pre-dose, 1 and 6 hours post-dose on Day 22
Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1
Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8
pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22
pre-dose, 1 and 6 hours post-dose on Day 22
Secondary Endpoints
Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1
pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1
Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8
pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22
pre-dose, 1 and 6 hours post-dose on Day 22
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
CVX-096BIOLOGICALSubcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum. * Hb A1c between 7-10%. * Fasting C-peptide \>0.4 nmol/L. E...

Countries:United States
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