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Also known as RO7040551
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 studied for Type 2 Diabetes Mellitus, Insulin Resistance, and Non-Alcoholic Fatty Liver Disease. It is in Phase 1 clinical development by Roche Holding AG (RHHBY). The drug is not approved and remains under investigation for these metabolic conditions.
BFKB8488A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in participants with insulin resistance, Type 2 Diabetes Mellitus, and Non-Alcoholic Fatty Liver Disease.
BFKB8488A is in Phase 1 clinical development. Two Phase 1 trials have been completed, 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 remains investigational.
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.
No alternative names for BFKB8488A have been disclosed. The drug is identified solely by its code name BFKB8488A in clinical trial records and development documentation from Roche Holding AG.