Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RO7795081, CT-996, RG6652
Tifeglipron · 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: Tifeglipron Dosing Regimen 1 | EXPERIMENTAL | - |
| Part A, Arm 4: Tifeglipron Dosing Regimen 2 | EXPERIMENTAL | - |
| Part A, Arm 5: Tifeglipron Dosing Regimen 3 | EXPERIMENTAL | - |
| Part A, Arm 6: Tifeglipron Dosing Regimen 4 | EXPERIMENTAL | - |
| Part A, Arm 7: Tifeglipron Dosing Regimen 5 | EXPERIMENTAL | - |
| Part A, Arm 8: Tifeglipron Dosing Regimen 6 | EXPERIMENTAL | - |
| Part A, Arm 9: Tifeglipron Dosing Regimen 7 | EXPERIMENTAL | - |
| Part B, Arm 1: Placebo | PLACEBO_COMPARATOR | - |
| Part B, Arm 2: Tifeglipron Dosing Regimen A | EXPERIMENTAL | - |
| Part B, Arm 3: Tifeglipron Dosing Regimen B | EXPERIMENTAL | - |
| Arm 1: Placebo | PLACEBO_COMPARATOR | - |
| Arm 2: Tifeglipron Dosing Regimen 1 | EXPERIMENTAL | - |
| Arm 3: Tifeglipron Dosing Regimen 2 | EXPERIMENTAL | - |
| Arm 4: Tifeglipron Dosing Regimen 3 | EXPERIMENTAL | - |
| Arm 5: Tifeglipron Dosing Regimen 4 | EXPERIMENTAL | - |
| Arm 6: Tifeglipron Dosing Regimen 5 | EXPERIMENTAL | - |
| Arm 7: Tifeglipron Dosing Regimen 6 | EXPERIMENTAL | - |
| Arm 8: Tifeglipron 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 |
|---|---|---|
| Tifeglipron | DRUG | Tifeglipron 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 tifeglipron will be taken orally QD during the 30-week treatment period. |
| RO7795081 | DRUG | Participants will receive RO7795081 as per the schedule described in the protocol. |
| 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...