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Also known as PF-08653944, MET097, MET-097i
Berobenatide · 12 trials · 12 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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo by Subcutaneous Injection. |
| Treatment Arm 1 | EXPERIMENTAL | Participants will receive Berobenatide by Subcutaneous Injection. |
| Treatment Arm 2 | EXPERIMENTAL | Participants will receive Berobenatide by Subcutaneous Injection. |
| Treatment Arm 3 | EXPERIMENTAL | Participants will receive Berobenatide by Subcutaneous Injection. |
| Treatment Arm 4 | EXPERIMENTAL | Participants will receive Berobenatide by Subcutaneous Injection. |
| Active Comparator | ACTIVE_COMPARATOR | Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection. |
| Experimental | EXPERIMENTAL | Participants will receive Berobenatide by Subcutaneous Injection. |
| Berobenatide Medium Maintenance Dose | EXPERIMENTAL | Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a medium maintenance dose during the maintenance phase. |
| Placebo Matched to Low-Dose Berobenatide | PLACEBO_COMPARATOR | Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase. |
| Berobenatide Low Maintenance Dose | EXPERIMENTAL | Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a low maintenance dose during the maintenance phase. |
| Berobenatide High Maintenance Dose | EXPERIMENTAL | Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a high maintenance dose during the maintenance phase. |
| Placebo Matched to Medium-Dose Berobenatide | PLACEBO_COMPARATOR | Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase. |
| Placebo Matched to High-Dose Berobenatide | PLACEBO_COMPARATOR | Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase. |
| Treatment Arm | EXPERIMENTAL | Participants will receive berobenatide by Subcutaneous Injection. |
| Treatment 1 | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1. |
| Treatment 2 | EXPERIMENTAL | Dosing subcutaneous berobenatide Reference Delivery System 2 |
| Treatment 3 | EXPERIMENTAL | Dosing subcutaneous berobenatide Test Delivery System 1 |
| Treatment 4 | EXPERIMENTAL | Dosing subcutaneous berobenatide Test Delivery System 2 |
| 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 4 (Optional) | EXPERIMENTAL | Japanese participants will receive a single SC dose of PF-08653944 on Day 1 administered to the abdomen. |
| Name | Type | Description |
|---|---|---|
| Berobenatide | DRUG | By Subcutaneous Injection |
| Placebo | OTHER | By Subcutaneous Injection |
| Semaglutide | DRUG | Participants will receive Semaglutide administered subcutaneously. |
| Tirzepatide | DRUG | Participants will receive Tirzepatide administered subcutaneously. |
| PF-08653944 | DRUG | By Subcutaneous Injection |
| Acetaminophen | DRUG | Oral suspension |
Inclusion Criteria: * Adults ≥18 years of age. * BMI ≥28 kg/m²; or BMI ≥24 kg/m² and \<28 kg/m² with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D. * At least one prior unsuccessful dietary weight-los...
Berobenatide is an investigational small molecule peptide developed by Pfizer for metabolic conditions, including overweight, obesity, and apnea. It is being studied in Phase 3 clinical trials, with additional early-stage studies evaluating how different forms of the medicine are absorbed into the blood. Berobenatide has not been established as an approved therapy.
Berobenatide is being developed for the treatment of overweight and obesity, and it is also being studied in apnea. Pfizer is running Phase 3 trials in adults with overweight or obesity, including a study of switching to a once-monthly form of the medicine to help keep weight off. These uses remain investigational.
Berobenatide is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is sponsoring the clinical program, including Phase 3 trials in adults with overweight or obesity and Phase 1 studies of how the medicine is taken up into the blood.
Berobenatide is in Phase 3 clinical development. Pfizer is running placebo-controlled, randomized, double-blind Phase 3 trials in adults with overweight or obesity, alongside earlier Phase 1 studies. Berobenatide is investigational and is not an approved medicine.
Berobenatide trials include NCT07845500, a recruiting Phase 3 study of switching to monthly Berobenatide to help keep weight off, and NCT07874633, a Phase 3 study in Chinese adults with overweight or obesity. Phase 1 studies include NCT07876531 and NCT07845513. Across its program, eight trials are listed with total enrollment of 3,823 participants.
Yes, Berobenatide is also known as PF-08653944. Pfizer uses both names across its clinical program, and several trial titles refer to the medicine as PF-08653944, including the Phase 3 study NCT07874633 in Chinese adults with overweight or obesity and the Phase 1 study NCT07845513.