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 A (Cohort 1) | EXPERIMENTAL | Participants will receive a single SC dose of PF 08653945 on Period 1 Day 1 administered to the abdomen. |
| 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 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 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. |
| 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 for overweight and obesity. It is a Phase 2 metabolic therapy studied in adults with overweight or obesity, including conditions such as overnutrition and body weight disorders. The drug is not approved and remains in clinical development.
PF-08653945 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials of this investigational small molecule for the treatment of overweight and obesity in adults.
PF-08653945 is in Phase 2 clinical development. It is being studied in a Phase 2 trial (NCT07575932) for overweight and obesity, along with a Phase 1 pharmacokinetic study (NCT07725809). The drug is investigational and not yet approved.
PF-08653945 is being evaluated in two trials. NCT07575932 is a Phase 2 study in adults with overweight or obesity, enrolling 872 participants in the United States and Canada. NCT07725809 is a Phase 1 study in Belgium examining how the drug is absorbed into the blood, enrolling 57 healthy adults.
PF-08653945 is distinct from PF-08653944, though both are being studied together in the Phase 2 SOLIS-1 trial (NCT07575932). The trial evaluates the combination of PF-08653945 and PF-08653944 in adults with overweight or obesity, but they are separate investigational compounds.