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Also known as Fulacimstat (BAY1142524)
Fulacimstat · 3 trials · 3 indications
The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment
AUC(0-tlast) will be used if mean AUC(tlast ∞) \>20% of AUC)
AUC (0-tlast) u will be used if mean AUC (tlast ∞) \>20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.
An additional blood sample for fu will be collected at 2 hours after dosing.
| Arm | Type | Description |
|---|---|---|
| Fulacimstat (BAY1142524) | EXPERIMENTAL | Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition |
| Placebo | PLACEBO_COMPARATOR | Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition |
| Normal (healthy subjects) | EXPERIMENTAL | Healthy subjects matched for age, body weight and gender to the groups with renal impairment |
| Mildly renal impaired | EXPERIMENTAL | Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m\*2 |
| Moderately renal impaired | EXPERIMENTAL | Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m\*2 |
| Severely renal impaired | EXPERIMENTAL | Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m\*2 |
| Name | Type | Description |
|---|---|---|
| Fulacimstat (BAY1142524) | DRUG | 25 mg BAY1142524 are given twice daily over a treatment period of 6 months |
| Placebo | DRUG | Matching placebo tablets are given twice daily over a treatment period of 6 months |
Inclusion Criteria: * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximu...
Fulacimstat is an investigational small molecule developed by Bayer AG under the code BAY1142524. It has been studied in clinical trials for diabetic kidney disease and for patients after acute myocardial infarction with left-ventricular dysfunction. It is not an approved medicine and remains in clinical development.
Fulacimstat was studied as a treatment for patients with type II diabetes and a clinical diagnosis of diabetic kidney disease. A completed Phase 2 trial, NCT03412006, enrolled 152 patients across Bulgaria, Denmark, Finland, Israel, Italy, Spain and Sweden to investigate its efficacy, safety and tolerability.
Fulacimstat targets CMA1, also known as chymase, and acts as an inhibitor of this enzyme. CMA1 inhibition is the mechanism explored in its clinical program. The compound is a small molecule and was tested in diabetic kidney disease and after acute myocardial infarction.
Fulacimstat is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the clinical trials of the compound, including the Phase 2 studies in diabetic kidney disease and in patients after acute myocardial infarction with left-ventricular dysfunction.
Fulacimstat is in Phase 1 development overall, with completed Phase 2 studies also conducted. It is investigational and has not been approved by the FDA. The Phase 1 renal impairment study, NCT03402438, enrolled 36 healthy volunteers in Germany and has been completed.
Fulacimstat has been evaluated in three completed trials: NCT03412006, a Phase 2 study in diabetic kidney disease with 152 patients; NCT02976467, a Phase 2 study after acute myocardial infarction with left-ventricular dysfunction with 107 patients; and NCT03402438, a Phase 1 renal impairment study with 36 healthy volunteers.
Yes, Fulacimstat is also known as BAY1142524. BAY1142524 is the Bayer development code for the same compound, and both names refer to the CMA1 inhibitor studied in diabetic kidney disease and after acute myocardial infarction. Searches for either name refer to the same investigational drug.