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BFKB8488A · 2 trials · 3 indications
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
| Arm | Type | Description |
|---|---|---|
| Multiple Ascending Dose BFKB8488A | EXPERIMENTAL | Participants will be randomized to receive BFKB8488A. When adequate safety data are available, a review will be done for all participants to make a dose-escalation or dose and/or regimen modification decision. This will be repeated for each cohort. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive BFKB8488A-matching placebo. |
| BFKB8488A SC | EXPERIMENTAL | Participants will receive single ascending SC dose of BFKB8488A in each dose escalation cohort. |
| BFKB8488A IV | EXPERIMENTAL | Participants will receive single IV dose of BFKB8488A. |
| Name | Type | Description |
|---|---|---|
| BFKB8488A | DRUG | Administered subcutaneously starting on Day 1 and according to dosing schedule. |
| Placebo | OTHER | Administered subcutaneously starting on Day 1 and according to dosing schedule. |
Inclusion Criteria: For T2DM Cohort only: * Body mass index (BMI) ≥ 27 kg/m2 and ≤ 40 kg/m2. * A confirmed diagnosis of Type 2 diabetes ≥ 6 months at screening * Current stable treatment (at least 3 months) for diabetes * Hemoglobin A1c (HbA1c) ≥ 6.8% and ≤ 9.0%. * For women of childbearing potent...
BFKB8488A is an investigational small molecule being developed by Roche Holding AG (RHHBY) for metabolic conditions, specifically Type 2 diabetes mellitus and insulin resistance. It has been studied in Phase 1 clinical trials in participants with these conditions, as well as in otherwise healthy overweight and obese participants with likely insulin resistance.
BFKB8488A is a small molecule developed by Roche Holding AG (RHHBY) for metabolic diseases. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its effects on insulin resistance and Type 2 diabetes mellitus, but its mechanism of action is not publicly detailed.
BFKB8488A is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical development of this investigational small molecule for metabolic indications, including Type 2 diabetes mellitus and insulin resistance.
BFKB8488A is in Phase 1 clinical development. It has completed two Phase 1 trials, one in otherwise healthy overweight and obese participants with likely insulin resistance and another in participants with Type 2 diabetes mellitus and non-alcoholic fatty liver disease. The drug is investigational and not yet approved.
BFKB8488A has been studied in two completed Phase 1 trials. NCT02593331 evaluated safety, tolerability, and pharmacokinetics in 79 healthy overweight and obese participants with likely insulin resistance in the United States. NCT03060538 was a multiple ascending dose study in 154 participants with Type 2 diabetes mellitus or non-alcoholic fatty liver disease in the United States and Canada.
BFKB8488A is the only name provided for this investigational drug. No alternative names or aliases have been associated with it in the available clinical trial information. It is a distinct small molecule being developed by Roche Holding AG for metabolic conditions.