Recent Updates
Recently added Catalysts

PF-04620110

Phase 1

Obesity | Small molecule | Metabolic |Pfizer, Inc.|Trials Updated: Nov 6, 2012

PF-04620110 development status

Highest phase Phase 1
Registered trials 6 across 1 sponsor since Nov 2008

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment146

FDA Designations

No designations recorded

PF-04620110 clinical trials

PF-04620110 · 3 trials · 4 indications

Phase 1 3
NCT01298518A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes PatientsType 2 Diabetes Patients
COMPLETED48 Analytics
NCT00959426A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy VolunteersObesity
COMPLETED71 Analytics
NCT00799006A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy VolunteersOverweight
COMPLETED27 Analytics
PHASE1COMPLETED
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
Type 2 Diabetes PatientsUnlock trial analytics
PHASE1COMPLETED
A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
ObesityUnlock trial analytics
PHASE1COMPLETED
A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
OverweightUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements.
Baseline to 2 weeks
To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.
Baseline to 2 weeks
To characterize the effect of PF-04620110 on postprandial lipid metabolism measures.
Baseline to 2 weeks
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements.
4 days/dose group
The single dose pharmacokinetics of PF-04620110 will be assessed
4 days/dose group

Secondary Endpoints

Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28
Baseline (Day -1); 24 hours post-dose on Day 28
Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-04620110EXPERIMENTAL -
placeboPLACEBO_COMPARATOR -
Placebo ComparatorPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-04620110DRUG5 mg of PF-04620110 given once daily
PlaceboDRUGMatching placebo giving for 4 weeks
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Male and/or female subjects between the ages of 18 and 60 years; * Body Mass Index (BMI) of \>25.0 kg/m2 and \<40 kg/m2; * Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines; * Subjects who have been on well-tolerated and stable doses of me...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about PF-04620110

What is PF-04620110?

PF-04620110 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for metabolic conditions. It has been studied in overweight and obese healthy volunteers and in patients with type 2 diabetes. It is a Phase 1 candidate and is not approved for any indication.

What is PF-04620110 used for?

PF-04620110 has been studied for obesity, overweight, and type 2 diabetes. Clinical trials enrolled overweight and obese otherwise healthy volunteers as well as patients with type 2 diabetes. All studies were Phase 1 and have been completed, so the drug remains investigational rather than an approved treatment.

Who makes PF-04620110?

Pfizer, Inc. (ticker PFE) is the developer of PF-04620110. The company sponsored the Phase 1 clinical program evaluating the small molecule in overweight and obese volunteers and in type 2 diabetes patients. No other developer or partnership is associated with the asset in its disclosed program.

What phase is PF-04620110 in?

PF-04620110 is in Phase 1 development. All three of its recorded clinical trials were Phase 1 studies, and all have been completed. The drug is investigational and has not been approved by the FDA for obesity, overweight, or type 2 diabetes.

What clinical trials is PF-04620110 in?

PF-04620110 has been evaluated in three completed Phase 1 trials: NCT01298518 in type 2 diabetes patients, NCT00959426 in overweight and obese healthy volunteers, and NCT00799006 in overweight healthy volunteers. All were conducted in the United States. No trials are currently active.

How many patients were enrolled in PF-04620110 trials?

The PF-04620110 program enrolled 146 participants across its three completed Phase 1 trials. NCT00959426 enrolled 71 overweight and obese healthy volunteers, NCT01298518 enrolled 48 type 2 diabetes patients, and NCT00799006 enrolled 27 overweight healthy volunteers. The studies were randomized, double-blind, and placebo-controlled.