Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CE-326, 597 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| CE-326,597 100 mg QD | EXPERIMENTAL | - |
| CE-326,597 50 mg QD | EXPERIMENTAL | - |
| CE-326,597 25 mg QD | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| CE-326,597 5mg QD | EXPERIMENTAL | - |
| CE-326,597 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CE-326,597 100 mg QD | DRUG | Administered orally, once daily with morning meal for duration of trial (84 days). |
| CE-326,597 50 mg QD | DRUG | Administered orally, once daily with morning meal for duration of trial (84 days). |
| CE-326,597 25 mg QD | DRUG | Administered orally, once daily with morning meal for duration of trial (84 days). |
| Placebo | DRUG | Placebo 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 QD | DRUG | Administered orally, once daily with morning meal for duration of trial (84 days). |
| CE-326,597 | DRUG | CE-326,597 administered orally, once daily for 14-days at 1 to 2 doses (25 mg QD, 100 mg QD) with the morning meal. |
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
CE-326,597 is an investigational small molecule being developed for weight management and the treatment of obesity. It has been studied in clinical trials for its effects on glucose control and body weight in diabetic patients, as well as in patients with asymptomatic gallstones.
CE-326,597 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in clinical development for metabolic conditions.
CE-326,597 is in Phase 1 clinical development. It has completed a Phase 1 study and a Phase 2 study, but it remains investigational and has not been approved by regulatory authorities.
CE-326,597 has been studied in two completed clinical trials. NCT00542009 was a Phase 2 trial in diabetic patients assessing effects on glucose control and body weight, enrolling 252 participants. NCT00576589 was a Phase 1 safety and pharmacokinetics study in patients with asymptomatic gallstones, enrolling 41 participants.
CE-326,597 is not FDA approved. It is an investigational drug that has completed early-stage clinical trials, including a Phase 1 and a Phase 2 study, but it has not received marketing approval for any indication.