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CE-326, 597

Phase 2

Weight Management | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Nov 7, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment252

FDA Designations

No designations recorded

Clinical trial landscape

CE-326, 597 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT00542009A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body WeightWeight Management
COMPLETED252 Analytics
PHASE2COMPLETED
A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight
Weight ManagementUnlock trial analytics

Study Endpoints

Primary Endpoints

Glucose control
At Day 84
Body weight
At Day 84
Safety and tolerability assessed via AEs/SAEs, plus where applicable gastrointestinal symptoms checklist, clinical laboratory tests, vital signs (blood pressure and pulse rate)
Day 1 to 14
CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax
Day 7

Secondary Endpoints

Regimen (dose or number) of anti-diabetic agents
At Day 84
GlycoMark
On Day 84
Waist circumference
On Day 84
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CE-326,597 100 mg QDEXPERIMENTAL -
CE-326,597 50 mg QDEXPERIMENTAL -
CE-326,597 25 mg QDEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
CE-326,597 5mg QDEXPERIMENTAL -
CE-326,597EXPERIMENTAL -

Interventions

NameTypeDescription
CE-326,597 100 mg QDDRUGAdministered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 50 mg QDDRUGAdministered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 25 mg QDDRUGAdministered orally, once daily with morning meal for duration of trial (84 days).
PlaceboDRUGPlacebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 5mg QDDRUGAdministered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597DRUGCE-326,597 administered orally, once daily for 14-days at 1 to 2 doses (25 mg QD, 100 mg QD) with the morning meal.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable. Exclusion Criteria: Women of childbearing potential, people with unstable medical conditions, people with gallstones

Countries:United StatesBulgariaCanadaIndiaMexicoPuerto RicoSpain
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Frequently asked questions about CE-326, 597

What is CE-326,597 used for?

CE-326,597 was studied for obesity and weight management. It is a small molecule developed by Pfizer, Inc. as an investigational treatment for weight management and treatment of obesity. It has been tested in patients with obesity and in diabetic patients to assess effects on glucose control and body weight.

Who makes CE-326,597?

CE-326,597 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer conducted the clinical trials of CE-326,597, including a Phase 1 study in patients with asymptomatic gallstones and a Phase 2 trial in diabetic patients.

What phase is CE-326,597 in?

CE-326,597 has completed a Phase 1 trial and a Phase 2 trial. The Phase 1 study evaluated safety and pharmacokinetics in patients with asymptomatic gallstones, while the Phase 2 trial assessed effects on glucose control and body weight in diabetic patients. No active trials are currently listed.

What clinical trials is CE-326,597 in?

CE-326,597 has been studied in two completed trials: NCT00576589, a Phase 1 study of safety and pharmacokinetics in patients with asymptomatic gallstones, and NCT00542009, a Phase 2 trial in diabetic patients to assess effects on glucose control and body weight. Both trials are completed.