Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7795081 · 6 trials · 8 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 |
|---|---|---|
| Arm 1: Placebo | PLACEBO_COMPARATOR | - |
| Arm 2: Semaglutide 14 mg | ACTIVE_COMPARATOR | - |
| Arm 3: RO7795081 Dosing Regimen 1 | EXPERIMENTAL | - |
| Arm 4: RO7795081 Dosing Regimen 2 | EXPERIMENTAL | - |
| Arm 5: RO7795081 Dosing Regimen 3 | EXPERIMENTAL | - |
| Arm 6: RO7795081 Dosing Regimen 4 | EXPERIMENTAL | - |
| Arm 7: RO7795081 Dosing Regimen 5 | EXPERIMENTAL | - |
| Arm 8: RO7795081 Dosing Regimen 6 | EXPERIMENTAL | - |
| Arm 9: RO7795081 Dosing Regimen 7 | EXPERIMENTAL | - |
| 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 |
| Part 1: RO7795081, Then RO7795081 and Itraconazole | EXPERIMENTAL | In Part 1, Period 1 (8 days), participants will be administered a single oral dose of RO7795081 on Day 1. Washout period between Period 1 Day 1 and Period 2 Day -3: at least 7 days. In Part 1, Period 2 (26 days), participants will receive a 3-day lead-in oral administration of itraconazole (200 mg twice daily \[BID\] on Day -3 and 200 mg once daily \[QD\] on Day -2 and Day -1). On Day 1, a single oral dose of RO7795081 will be co-administered with itraconazole (200 mg QD), followed by continued itraconazole dosing (200 mg QD) from Day 2 up to and including Day 9. |
| Part 2: RO7795081, Then RO7795081 and Gemfibrozil, Then RO7795081 and Cyclosporine | EXPERIMENTAL | In Part 2, Period 1 (8 days), participants will be administered a single oral dose of RO7795081 on Day 1. Washout period between Period 1 Day 1 and Period 2 Day -2: at least 7 days. In Part 2, Period 2 (10 days), participants will be co-administered a single oral dose of RO7795081 with gemfibrozil (600 mg BID) on Day 1, after a 2-day lead-in oral administration of gemfibrozil 600 mg BID (Day -2 to Day -1) followed by continued BID dosing up to and including Day 3. Washout period between Period 2 Day 1 and Period 3 Day 1: at least 7 days. In Part 2, Period 3 (8 days), participants will be co-administered a single oral dose of RO7795081 and a single oral dose of cyclosporine (200 mg) on Day 1. Washout period between Period 3 Day 1 and Period 4 Day 1: at least 7 additional days after Period 3 Day 7 (total of 14 days). In Part 2, Period 4 (18 days), participants will be co-administered a single oral dose of RO7795081 and a single oral dose of cyclosporine (600 mg or less) on Day 1. |
| 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 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. |
| Itraconazole | DRUG | Administered orally (see arm description). |
| Gemfibrozil | DRUG | Administered orally (see arm description). |
| Cyclosporine | DRUG | A single dose will be administered orally per study period (see arm descriptions). |
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 small molecule being developed by Roche Holding AG (RHHBY) for conditions including overweight, obesity, and type 2 diabetes mellitus. It is currently in clinical development, with trials spanning Phase 1 and Phase 2. The drug is administered orally and is being studied in various populations, including healthy volunteers and those with weight-related comorbidities.
RO7795081 is being studied for use in overweight and obesity, including in individuals with at least one weight-related comorbidity. It is also being investigated in type 2 diabetes mellitus and in healthy participants to assess safety and drug interactions. The ongoing clinical trials focus on its effects on body weight and how the body processes other medications.
RO7795081 is developed by Roche Holding AG, a multinational healthcare company. The company's stock is traded under the ticker RHHBY. Roche is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of RO7795081 in various populations, including healthy volunteers and individuals with obesity or overweight.
RO7795081 is in Phase 1 and Phase 2 clinical development. Phase 1 trials are investigating safety, tolerability, and drug interactions in healthy participants and those who are overweight or obese. A Phase 2 trial has been completed, evaluating the effect of daily oral RO7795081 in participants with obesity or overweight and at least one weight-related comorbidity.
RO7795081 is being studied in several clinical trials. NCT06809608 is a completed Phase 1 study on drug interactions in healthy participants. NCT06982131 is a recruiting Phase 1 trial in overweight or obese adults. NCT07081958 is a completed Phase 2 trial in obesity or overweight with comorbidities. NCT07499050 is an active Phase 1 study in Chinese participants with obesity or overweight.
RO7795081 is not FDA approved. It is an investigational drug currently in clinical development. The available trials are in Phase 1 and Phase 2, meaning the drug has not yet completed the clinical trial process required for regulatory approval. Its safety and efficacy are still being evaluated in clinical studies.