Safety, tolerability, pharmacodynamics and pharmacokinetics of the soluble guanylyl cyclase activator BI 685509 in patients with diabetic kidney disease: A randomized trial
Authors' conclusion
BI 685509 was generally well tolerated. Effects on UACR lowering merit further investigation.
Study context
- Population
- Patients with T1D or T2D, estimated glomerular filtration rate (eGFR) 20–75 mL/min/1.73 m² and urinary albumin:creatinine ratio (UACR) 200–3500 mg/g; baseline median eGFR 47.0 mL/min/1.73 m², UACR 641.5 mg/g
- Participants
- 20 / 19 / 20 / 15
- Comparison
- Oral BI 685509 vs placebo for 28 days
- 1 mg three times dailyn = 20
- 3 mg once dailyn = 19
- 3 mg three times dailyn = 20
- Placebon = 15reference
Methodological detailsphase Ib, placebo-controlled
- Phase Ib
- Placebo-controlled
Primary result
As reported in the abstract
Safety: drug-related AEs · 28 days
BI 685509
9
events
Placebo
3
events
- Patients with drug-related adverse events (AEs), overall
- 12 (16.2%)
Further findings
| Outcome | 3 mg once daily | 3 mg three times daily | Placebo-corrected mean change | P value |
|---|---|---|---|---|
| Placebo-corrected mean change from baseline in UACR in first morning void · 28 days3 mg once daily vs Placebo · decrease | 28.8% | P = 0.23 | ||
| Placebo-corrected mean change from baseline in UACR in first morning void · 28 days3 mg three times daily vs Placebo · decrease | 10.2% | P = 0.71 | ||
| Placebo-corrected mean change from baseline in UACR in first morning void · 28 days1 mg three times daily vs Placebo · increase | 6.6% | P = 0.82 | ||
| Change in UACR in 10-hour urine · 28 days | 35.3% | 56.7% | ||
| Decrease, P | P = 0.34 | P = 0.09 |
- Change in UACR in 10-hour urine — Responders (≥20% UACR decrease from baseline), 3 mg once daily/three times daily
- ≥50.0% of patients
Placebo-corrected mean change from baseline in UACR in first morning void · 28 days
- Changes were not significant
Safety
- Drug-related hypotension — Placebo
- 1 events
- Drug-related diarrhoea — Placebo
- 0 events
- AEs leading to study discontinuation — Placebo
- 1 events
- Drug-related hypotension — Overall
- 4.1%
- Drug-related diarrhoea — Overall
- 2.7%
- AEs leading to study discontinuation — Overall
- 4 (5.4%)
- Drug-related hypotension: BI 685509 2 events
- Drug-related diarrhoea: BI 685509 2 events
- AEs leading to study discontinuation: BI 685509 3 events
Original publication
Safety, tolerability, pharmacodynamics and pharmacokinetics of the soluble guanylyl cyclase activator BI 685509 in patients with diabetic kidney disease: A randomized trial. Diabetes Obes Metab. Published 25 May 2023. doi:10.
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