A Phase 2 interventional study of CE-326,597 100 mg QD and CE-326,597 50 mg QD in Weight Management and Treatment Of Obesity, sponsored by Pfizer. Completed at 54 sites in 7 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-11-07.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 252 is above the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Drug: CE-326,597 100 mg QD
Drug: CE-326,597 50 mg QD
Drug: CE-326,597 25 mg QD
Drug: Placebo
Drug: CE-326,597 5mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
Administered orally, once daily with morning meal for duration of trial (84 days).
Administered orally, once daily with morning meal for duration of trial (84 days).
Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
Administered orally, once daily with morning meal for duration of trial (84 days).
Glucose control
Time frame: At Day 84
Body weight
Time frame: At Day 84
Regimen (dose or number) of anti-diabetic agents
Time frame: At Day 84
GlycoMark
Time frame: On Day 84
Waist circumference
Time frame: On Day 84
Proportion of subjects who achieve HbA1C <7% and <6.5%
Time frame: On Day 84
Population PK to analyze CE-326,597 concentrations as well as explore relationship of concentration to effect on HbA1C and body weight over duration of trial.
Time frame: Throughout Study
Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.
Time frame: Throughout Study
Change in following parameters: Post-prandial and fasting glucose, and insulin
Time frame: On Day 28
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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