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CVX-096

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

CVX-096 · 1 trial · 1 indication

Phase 1 1
NCT00886821A Safety and Pharmacokinetic Study of CVX-096 in Type 2 DiabeticsDiabetes Mellitus, Type 2
COMPLETED114 Analytics
PHASE1COMPLETED
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
Diabetes Mellitus, Type 2Unlock trial analytics

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 to 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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Frequently asked questions about CVX-096

What is CVX-096 used for?

CVX-096 is an investigational monoclonal antibody being studied for the treatment of Type 2 Diabetes Mellitus. It is being developed by Pfizer, Inc. (NYSE: PFE) as a potential therapy for this metabolic condition.

Who makes CVX-096?

CVX-096 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational monoclonal antibody in clinical development for Type 2 Diabetes Mellitus.

What phase is CVX-096 in?

CVX-096 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its safety and pharmacokinetics in patients with Type 2 Diabetes Mellitus.

What clinical trials is CVX-096 in?

CVX-096 has one completed Phase 1 clinical trial, identified as NCT00886821, titled "A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics." This trial enrolled 114 participants in the United States and was a randomized, double-blind study.

Is CVX-096 FDA approved?

CVX-096 is not FDA approved. It is an investigational monoclonal antibody currently in Phase 1 clinical development for Type 2 Diabetes Mellitus. The drug has completed a Phase 1 safety and pharmacokinetic study but remains in clinical investigation.