Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-08653945 · 2 trials · 9 indications
AUC is a measure of the plasma concentration of the study drug over time. It is used to characterize absorption of the drug.
Cmax refers to the maximum observed serum concentration of the study drug.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants receive subcutaneous injections of PF-08653945 or placebo. |
| Cohort 2 | EXPERIMENTAL | Participants receive subcutaneous injections of PF-08653945 + PF-08653944 or placebo. |
| Cohort 3 | EXPERIMENTAL | Participants receive subcutaneous injections of PF-08653945 + PF-08653944 , PF-08653944 , or placebo. |
| Treatment C (Cohort 1) | EXPERIMENTAL | Participants will receive a single SC dose of PF 08653945 on Period 1 Day 1 administered to the upper arm. |
| Treatment B (Cohort 1) | EXPERIMENTAL | Participants will receive a single SC dose of PF 08653945 on Period 1 Day 1 administered to the thigh. |
| Treatment A (Optional Cohort 2) | EXPERIMENTAL | Japanese participants will receive a single SC dose of PF 08653945 on Period 1 Day 1 administered to the abdomen. |
| Treatment A (Cohort 1) | EXPERIMENTAL | Participants will receive a single SC dose of PF 08653945 on Period 1 Day 1 administered to the abdomen. |
| Name | Type | Description |
|---|---|---|
| PF-08653945 | DRUG | Subcutaneous Injection |
| PF-08653944 | DRUG | Subcutaneous Injection |
| Placebo | DRUG | Subcutaneous Injection |
Inclusion Criteria: Eligible participants for this study include: * adults aged 18 years or older with * obesity (BMI of 30.0 kg/m2 to 50.0 kg/m2) or with * overweight (BMI of 27.0 kg/m2 to \<30.0 kg/m2) who also have at least 1 prespecified weight-related comorbidity (hypertension, dyslipidemia, ...
PF-08653945 is an investigational small molecule being developed by Pfizer, Inc. (NYSE: PFE) for the treatment of overweight and obesity. It is in Phase 2 clinical development and has not been approved by the FDA. Two clinical trials of PF-08653945 are ongoing, with a combined planned enrollment of 997 participants.
PF-08653945 is being studied for use in adults with overweight or obesity. The Phase 2 trial NCT07575932 enrolls adults with overweight and/or obesity, while the Phase 1 trial NCT07725809 includes adults with overweight or obesity as well as healthy volunteers. It is investigational and not approved for any indication.
PF-08653945 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of both registered clinical trials of the compound, the Phase 1 study NCT07725809 and the Phase 2 study NCT07575932.
PF-08653945 is in Phase 2 clinical development. The Phase 2 trial NCT07575932 is active but no longer recruiting, and the Phase 1 trial NCT07725809 is currently recruiting. PF-08653945 is investigational and has not received FDA approval.
PF-08653945 is being evaluated in two registered trials. NCT07575932 is a Phase 2 study of PF-08653945 and PF-08653944 in adults with overweight or obesity, enrolling 940 participants in the United States and Canada. NCT07725809 is a Phase 1 study in adults with overweight or obesity or healthy volunteers, enrolling 57 participants in Belgium.
Yes. The clinical program for PF-08653945 includes randomized, double-blind, controlled trial designs. The Phase 2 study NCT07575932 is a randomized, double-blind, controlled trial of PF-08653945 and PF-08653944 in adults with overweight or obesity, with 940 participants enrolled across sites in the United States and Canada.