Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-08653944 · 5 trials · 7 indications
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen
To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1 | EXPERIMENTAL | Participants will receive PF-08653944 by Subcutaneous Injection. |
| Treatment Arm 2 | EXPERIMENTAL | Participants will receive PF-08653944 by Subcutaneous Injection. |
| Treatment Arm 3 | EXPERIMENTAL | Participants will receive PF-08653944 by Subcutaneous Injection. |
| Treatment Arm 4 | EXPERIMENTAL | Participants will receive PF-08653944 by Subcutaneous Injection. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo by Subcutaneous Injection. |
| Group 1 | EXPERIMENTAL | Participants without Hepatic Impairment (HI) will receive a single dose of PF-08653944, administered as Subcutaneous (SC) injection. |
| Group 2 | EXPERIMENTAL | Participants with mild HI will receive a single dose of PF-08653944, administered as SC injection. |
| Group 3 | EXPERIMENTAL | Participants with moderate HI will receive a single dose of PF-08653944, administered as SC injection. |
| Group 4 | EXPERIMENTAL | Participants with severe HI will receive a single dose of PF 08653944, administered as SC injection. |
| Period 1 | EXPERIMENTAL | Participants will receive a single oral dose of acetaminophen. |
| Period 2 | EXPERIMENTAL | Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen. |
| Period 3 | EXPERIMENTAL | Participants will receive SC dose of PF-0865394. |
| Period 4 | EXPERIMENTAL | Participants will receive SC dose of PF-0865394. |
| Period 5 | EXPERIMENTAL | Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen. |
| Period 6 | EXPERIMENTAL | Participants will receive single SC dose of PF-08653944 and single oral dose of acetaminophen. |
| Treatment 1 | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1 administered to the abdomen. |
| Treatment 2 | EXPERIMENTAL | Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the thigh. |
| Treatment 3 | EXPERIMENTAL | Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the upper arm. |
| Treatment 4 (Optional) | EXPERIMENTAL | Japanese participants will receive a single SC dose of PF-08653944 on Day 1 administered to the abdomen. |
| Name | Type | Description |
|---|---|---|
| PF-08653944 | DRUG | By Subcutaneous Injection |
| Placebo | OTHER | By Subcutaneous Injection |
| Acetaminophen | DRUG | Oral suspension |
Inclusion Criteria: * Aged ≥18 years. * BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to \<30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D. Exclusion Criteria: * Have a self-reported body we...
Top 20 of 32 competitors
PF-08653944 is an investigational small molecule being studied for use in people who are overweight or have obesity, including those with type 2 diabetes. It is also being evaluated in healthy adults to understand how the body processes the medicine and its effects on stomach emptying.
PF-08653944 targets the GLP-1 receptor, a protein involved in regulating blood sugar and appetite. By acting on this receptor, the drug is being studied for its potential effects in overweight and obesity, including in people with type 2 diabetes.
PF-08653944 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and effects in various populations.
PF-08653944 is in Phase 1 clinical development, with multiple early-stage trials underway or completed. One Phase 3 trial is listed as active but not recruiting, though the drug remains investigational and has not been approved by regulatory authorities.
PF-08653944 is being studied in several trials, including NCT07400653, a Phase 3 study in people with obesity or overweight and type 2 diabetes; NCT07400679, a completed Phase 1 study on drug absorption; NCT07508241, a Phase 1 study on stomach emptying; and NCT07519135, a Phase 1 study in people with reduced liver function.
PF-08653944 is a distinct investigational small molecule that targets the GLP-1 receptor, similar to other drugs in this class. However, it is not the same as any approved GLP-1 receptor agonist, and no alternative names for PF-08653944 have been disclosed.