Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO6811135 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| RO6811135 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Matching placebo, multiple doses |
| RO6811135 | DRUG | multiple ascending doses |
Inclusion Criteria: * Adult patients, 18 to 65 years of age, inclusive * Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening * On stable dose of metformin for at least 2 months prior to screening * Fasting plasma glucose during the screening period ...
RO6811135 is an investigational small molecule developed by Roche Holding AG for the treatment of type 2 diabetes mellitus. It has been studied in a Phase 1 clinical trial evaluating its safety, pharmacokinetics, and pharmacodynamics in patients with type 2 diabetes. It is not an approved therapy and remains in clinical development.
RO6811135 was studied as a potential treatment for type 2 diabetes mellitus, a metabolic condition characterized by elevated blood glucose. The clinical program evaluated its safety, pharmacokinetics, and pharmacodynamics in adult patients with the disease. It is investigational and has not been approved for prescribing in any indication.
RO6811135 is developed by Roche Holding AG, the Swiss pharmaceutical company whose shares trade over the counter in the United States under the ticker RHHBY. Roche sponsored the Phase 1 study of the compound in patients with type 2 diabetes mellitus conducted in the United States.
RO6811135 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed for the compound. Because it is investigational, RO6811135 is not FDA approved and is not available as a commercial treatment for type 2 diabetes or any other condition.
RO6811135 has been evaluated in one completed Phase 1 trial, NCT01789788, titled A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus. The randomized, double-blind, placebo-controlled study enrolled 56 adults aged 18 years and older in the United States.
The Phase 1 trial of RO6811135, NCT01789788, was a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus rather than healthy volunteers. It enrolled 56 participants aged 18 years and older across sites in the United States and assessed safety, pharmacokinetics, and pharmacodynamics. The trial is completed.