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Also known as RO7795068, CT-388, RG6640
Enicepatide · 5 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| Enicepatide Dose 1 | EXPERIMENTAL | Participants will receive enicepatide Dose 1. |
| Enicepatide Dose 2 | EXPERIMENTAL | Participants will receive enicepatide Dose 2. |
| Enicepatide Dose 3 | EXPERIMENTAL | Participants will receive enicepatide Dose 3. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| Arm 1: Placebo | PLACEBO_COMPARATOR | - |
| Arm 2: Enicepatide Dosing Regimen 1 | EXPERIMENTAL | - |
| Arm 3: Enicepatide Dosing Regimen 2 | EXPERIMENTAL | - |
| Arm 4: Enicepatide Dosing Regimen 3 | EXPERIMENTAL | - |
| Arm 2: Enicepatide Dose Level 1 (Low) | EXPERIMENTAL | - |
| Arm 3: Enicepatide Dose Level 2 | EXPERIMENTAL | - |
| Arm 4: Enicepatide Dose Level 3 | EXPERIMENTAL | - |
| Arm 5: Enicepatide Dose Level 4 (High) | EXPERIMENTAL | - |
| Arm 5: Enicepatide Dose Level 4 | EXPERIMENTAL | Enicepatide Dose Level 4 administered SC once weekly. |
| Arm 6: Enicepatide Dose Level 5 (High) | EXPERIMENTAL | Enicepatide Dose Level 5 administered SC once weekly. |
| Name | Type | Description |
|---|---|---|
| Enicepatide | COMBINATION_PRODUCT | Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol. |
| Placebo | COMBINATION_PRODUCT | Participants will receive matching placebo via SC injection as per the schedule in the protocol. |
Inclusion Criteria: * Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m\^2) for participants with type 2 diabetes mellitus (T2DM) * BMI ≥28.0 kg/m\^2 or BMI ≥24.0 and \<28.0 kg/m\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatt...
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Enicepatide is an investigational small molecule developed by Roche Holding AG for the treatment of obesity and overweight, including in people with type 2 diabetes. It is being studied in Phase 3 clinical trials and has not been approved by the FDA. It belongs to the peptide class of medicines.
Enicepatide is being developed to treat obesity and overweight, both with and without type 2 diabetes. Clinical trials are enrolling adults 18 years and older who are obese or overweight, including participants with type 2 diabetes mellitus. It is investigational and has not been approved for any indication.
Enicepatide is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is running the Phase 3 clinical program for the drug, including studies conducted across the United States, China, Europe, Asia, and other regions.
Enicepatide is in Phase 3 clinical development. Two Phase 3 trials are currently recruiting, and a Phase 2 study in overweight or obese participants with type 2 diabetes has been completed and is no longer recruiting. The drug is investigational and has not received FDA approval.
Enicepatide is being studied in Phase 3 trials NCT07670416, NCT07351058, and NCT07351045, which are recruiting adults with obesity or overweight, with or without type 2 diabetes. A completed Phase 2 trial, NCT06628362, enrolled 447 participants who were overweight or obese with type 2 diabetes.
Yes, Enicepatide is also known as CT-388 and RO7795068. The Phase 2 trial NCT06628362 refers to the drug as CT-388, while the Phase 3 studies NCT07351058 and NCT07351045 refer to it as Enicepatide (RO7795068). All three names refer to the same investigational compound.