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Also known as RO7895515, ZP8396
Petrelintide · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Petrelintide | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Arm 1: Petrelintide + Enicepatide Dosing Regimen 1 | EXPERIMENTAL | - |
| Arm 2: Petrelintide + Enicepatide Dosing Regimen 2 | EXPERIMENTAL | - |
| Arm 3: Petrelintide + Enicepatide Dosing Regimen 3 | EXPERIMENTAL | - |
| Arm 4: Petrelintide-matching Placebo + Enicepatide | EXPERIMENTAL | - |
| Arm 5: Petrelintide + Enicepatide-matching Placebo | EXPERIMENTAL | - |
| Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Petrelintide | COMBINATION_PRODUCT | Petrelintide will be administered subcutaneously (SC) using a drug-device combination product. |
| Placebo | COMBINATION_PRODUCT | Petrelintide-matching placebo will be administered SC using a drug-device combination product. |
| Enicepatide | COMBINATION_PRODUCT | Enicepatide will be administered subcutaneously to participants once weekly |
| Petrelintide-matching Placebo | DRUG | Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly |
| Enicepatide-matching Placebo | COMBINATION_PRODUCT | Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly |
Inclusion Criteria: * Participants with BMI ≥ 27 kg/m² and established CVD * History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: * Known history of Type 1 diabetes mellitus * Current or previous treatment with petrelintide or any other amylin ...
Petrelintide is an investigational small molecule being developed for the treatment of obesity or overweight. It is also being studied in patients who have obesity or overweight alongside type 2 diabetes or established cardiovascular disease. It has not been approved for any use and remains in clinical development.
Petrelintide is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is running the clinical development program, including the Phase 3 studies in obesity or overweight and a Phase 2 dose-finding study combining petrelintide with enicepatide (RO7795068).
Petrelintide is in Phase 3 development for obesity or overweight. Three Phase 3 trials are currently recruiting, and a Phase 2 dose-finding study of petrelintide with enicepatide is not yet recruiting. Petrelintide is investigational and has not been approved by the FDA.
Petrelintide is being studied in four trials. The Phase 3 studies are NCT07843498 in overweight or obesity, NCT07843485 in overweight or obesity with type 2 diabetes, and NCT07843472 in overweight or obesity with established cardiovascular disease. The Phase 2 dose-finding study with enicepatide is NCT07589686.
The Petrelintide clinical program plans to enroll about 7,486 participants across four trials. The largest is the Phase 3 study NCT07843498 with 3,900 participants, followed by NCT07843472 with 2,500, NCT07843485 with 600, and the Phase 2 study NCT07589686 with 486.
Yes. The Petrelintide trials are randomized, double-blind, and placebo-controlled. Participants are adults aged 18 and older in most studies, while the cardiovascular disease trial NCT07843472 enrolls adults aged 40 and older. The Phase 3 studies are recruiting in the United States.