PPAR ?
Selective Peroxisome Proliferator Activated Receptor Alpha
Low HDL & DM

A Phase 2, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Evaluate the Effect of CP-778,875 on HDL-Cholesterol in Adult Subjects with Dyslipidemia and Type 2 Diabetes Mellitus

Sponsor: Pfizer
Study Drug: CP-778,875 (Selective PPAR ? Agonist) 0.5, 2, 6mgm or Placebo
Protocol: A5561005
Phase 2
CRO:
CRA: Site #:
Investigator #:
CRA
: Central Lab:
IRB:
Subjects / Sites -> Subjects per Site
PPARs are transcription factors belonging to the superfamily of nuclear receptors that modulate the transcription of genes responsible for numerous cellular processes. PPAR alpha regulates the expression of genes involved in lipid and glucose homeostasis.

10 April 2006
VERSION: 1 2 3 4 5 6 7 8 9

PPAR ?
Selective Peroxisome Proliferator Activated Receptor Alpha
Low HDL & DM

IC
30-65
Diabetic on: Glucophage or Glucophage + SU (No SU alone!)
FBS: 150-220 & HbA1C 7.0-10
Low HDL-> Men: greater than/equal to 40 Women: less than/equal to 50 AND ? TG 150-500
BMI 25-40
Must be on at least the following doses:
Glucophage: greater than/equal to 1000
Amaryl greater than/equal to 4
Glucotrol: 10

EC
CAD
AF
equal/greater than 150/90
TIA/CVA
PVD
CRF Men > 1.5 Women > 1.4
LFT >2x
TSH > 2x
Cancer
Any Cholesterol lowering med within 30 days V1
SU monotherapy
Insulin
TZD
Herbal Supplements

10 April 2006
VERSION: 1 2 3 4 5 6 7 8 9

PPAR ?
Selective Peroxisome Proliferator Activated Receptor Alpha
Low HDL & DM

V1 W -4 Lab, Screening Visit, EKG
V2 W -3 Lab, Screening Visit
V3 W -2 Single-Blind Run-In Period, FSG
V4 W 0 Lab R, FSG, EKG
V5 W 1 Lab
V6 W 2 Lab, FSG
V7 W 3 Lab
V8 W 4 Lab, FSG
V9 W 5 Lab
V10 W6 Lab, FSG, EKG