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Also known as CT-996, RG6652
RO7795081 · 5 trials · 7 indications
Participants with psychiatric abnormalities include those with a Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at any assessment, any suicidal behavior, or any suicidal ideation of Type 4 (active suicidal ideation with some intent to act without a specific plan) or Type 5 (active suicidal ideation with a specific plan and intent) on any Columbia-Suicide Severity Rating Scale (C-SSRS) assessment.
| Arm | Type | Description |
|---|---|---|
| Part A, Arm 1: Placebo | PLACEBO_COMPARATOR | - |
| Part A, Arm 2: Semaglutide 14 mg | ACTIVE_COMPARATOR | - |
| Part A, Arm 3: RO7795081 Dosing Regimen 1 | EXPERIMENTAL | - |
| Part A, Arm 4: RO7795081 Dosing Regimen 2 | EXPERIMENTAL | - |
| Part A, Arm 5: RO7795081 Dosing Regimen 3 | EXPERIMENTAL | - |
| Part A, Arm 6: RO7795081 Dosing Regimen 4 | EXPERIMENTAL | - |
| Part A, Arm 7: RO7795081 Dosing Regimen 5 | EXPERIMENTAL | - |
| Part A, Arm 8: RO7795081 Dosing Regimen 6 | EXPERIMENTAL | - |
| Part A, Arm 9: RO7795081 Dosing Regimen 7 | EXPERIMENTAL | - |
| Part B, Arm 1: Placebo | PLACEBO_COMPARATOR | - |
| Part B, Arm 2: RO7795081 Dosing Regimen A | EXPERIMENTAL | - |
| Part B, Arm 3: RO7795081 Dosing Regimen B | EXPERIMENTAL | - |
| Arm 1: Placebo | PLACEBO_COMPARATOR | - |
| Arm 2: RO7795081 Dosing Regimen 1 | EXPERIMENTAL | - |
| Arm 3: RO7795081 Dosing Regimen 2 | EXPERIMENTAL | - |
| Arm 4: RO7795081 Dosing Regimen 3 | EXPERIMENTAL | - |
| Arm 5: RO7795081 Dosing Regimen 4 | EXPERIMENTAL | - |
| Arm 6: RO7795081 Dosing Regimen 5 | EXPERIMENTAL | - |
| Arm 7: RO7795081 Dosing Regimen 6 | EXPERIMENTAL | - |
| Arm 8: RO7795081 Dosing Regimen 7 | EXPERIMENTAL | - |
| Group 1: Participants with Normal Renal Function, RO7795081 | EXPERIMENTAL | Participants with normal renal function will receive a single oral dose of RO7795081. |
| Group 2: Participants with Severe Renal Impairment, RO7795081 | EXPERIMENTAL | Participants with severe renal impairment or kidney failure not receiving dialysis will receive a single oral dose of RO7795081. |
| Group 3: Participants with Moderate Renal Impairment, RO7795081 | EXPERIMENTAL | Participants with moderate renal impairment will receive a single oral dose of RO7795081. |
| Group 4: Participants with Mild Renal Impairment, RO7795081 | EXPERIMENTAL | Participants with mild renal impairment will receive a single oral dose of RO7795081. |
| RO7795081 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Arm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, Then RO7795081 + ROS, Then RO7795081 + PIT | EXPERIMENTAL | Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: RO7795081 alone; Period 4: RO7795081 in combination with ROS; Period 5: RO7795081 in combination with PIT |
| Arm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then Placebo + ROS, Then Placebo + PIT | PLACEBO_COMPARATOR | Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: Placebo alone; Period 4: Placebo in combination with ROS; Period 5: Placebo in combination with PIT |
| Name | Type | Description |
|---|---|---|
| RO7795081 | DRUG | RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. |
| Semaglutide | DRUG | Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period. |
| Placebo | DRUG | Placebo matching RO7795081 will be taken orally QD during the 30-week treatment period. |
| Rosuvastatin | DRUG | A single 10 mg dose of rosuvastatin (ROS) will be taken on Day 1 of Period 1 and on Day 1 of Period 4. |
| Pitavastatin | DRUG | A single 1 mg dose of pitavastatin (PIT) will be taken on Day 1 of Period 2 and on Day 1 of Period 5. |
Inclusion Criteria: * Have a diagnosis of Type 2 diabetes mellitus (T2D) for at least 6 months before screening * Have an HbA1c ≥7% and ≤10.5% at screening * Management of T2D with diet and exercise alone or with either a stable dose of metformin or/and sodium-glucose cotransporter-2 (SGLT-2) inhib...
RO7795081 is an investigational oral small molecule developed by Roche Holding AG for metabolic conditions. It is being studied in obesity or overweight, type 2 diabetes mellitus, and renal impairment. It has not been approved by any regulatory agency and remains in clinical development.
RO7795081 is being studied for obesity or overweight, including overweight with at least one weight-related comorbidity, for type 2 diabetes mellitus, and for renal impairment. These are investigational uses only. No regulatory approval has been granted, and the drug remains in clinical development.
RO7795081 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is running the clinical program, including Phase 1 and Phase 2 studies in obesity or overweight, type 2 diabetes mellitus, and renal impairment.
RO7795081 is in Phase 2 clinical development. A completed Phase 2 trial evaluated daily oral RO7795081 in participants with obesity or overweight plus at least one weight-related comorbidity, and another Phase 2 trial compares doses with placebo or semaglutide in type 2 diabetes.
RO7795081 has four registered trials. NCT07081958, a completed Phase 2 obesity or overweight study, and NCT07112872, an active Phase 2 type 2 diabetes study comparing doses with placebo or semaglutide, are the largest. Phase 1 studies NCT07741604 in renal impairment and NCT07499050 in Chinese adults with obesity or overweight are also listed.
No. RO7795081 is investigational and has not been approved by the FDA. It is still in clinical development, with Phase 2 trials in obesity or overweight and type 2 diabetes mellitus and Phase 1 trials in renal impairment and in Chinese adults with obesity or overweight.