Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon‐like peptide‐1 receptor agonist BI 456906
Authors' conclusion
BI 456906 produced a placebo-corrected body weight loss of 13.8% (week 16), highlighting its potential to promote clinically meaningful body weight loss in people with overweight/obesity.
Study context
- Population
- Phase Ia: males with body mass index (BMI) 20-<30 kg/m²; phase Ib: adults with BMI 27–40 kg/m² (overweight/obesity)24 SRD + 125 MRD
- Comparison
- BI 456906 vs placebo
Methodological detailssingle rising dose (phase Ia), multiple rising dose (phase Ib)
- Single rising dose (phase Ia)
- Multiple rising dose (phase Ib)
Primary result
As reported in the abstract
Body weight
MRD Part A: max placebo-corrected mean body weight decrease, week 6 (DS1)
−5.79%
MRD Part B: max placebo-corrected mean body weight decrease, week 16 (DS7)
−13.8%
Further findings
Pharmacodynamics
- BI 456906 reduced plasma amino acids and glucagon, indicating target engagement at GCGRs and GLP-1Rs
Safety
- SRD: most frequent drug-related AE, decreased appetite
- n = 9, 50.0%
- SRD: did not complete because of adverse events (AEs) (nausea and vomiting)
- 2 (8.3%)
- MRD Part A (N = 80): discontinued BI 456906
- 10 (12.5%)
- MRD Part A: discontinued due to cardiac or vascular AE
- n = 6, 7.5%
- MRD Part B (N = 45): discontinued BI 456906
- 8 (17.8%)
- MRD Part B: discontinued due to AEs, mostly gastrointestinal
- n = 6, 13.3%
- Drug-related AEs increased with BI 456906 dose
Original publication
Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon‐like peptide‐1 receptor agonist BI 456906. Diabetes Obes Metab. Published 30 January 2023. doi:10.
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