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Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon‐like peptide‐1 receptor agonist BI 456906
Early tests of the safety and body effects of BI 456906, a drug that activates both glucagon and GLP-1 receptors
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Abstract
A placebo-corrected body weight loss of 13.8% was observed at week 16 with the use of BI 456906 in adults with overweight or obesity.
- Mean body weight decreased with increasing doses of BI 456906 in a phase Ia study involving 24 males.
- In the phase Ib study, maximum reductions in body weight occurred at week 6 and week 16, with decreases of -5.79% and -13.8%, respectively.
- Treatment with BI 456906 was associated with reductions in plasma amino acids and glucagon, suggesting effective target engagement.
- Drug-related adverse events increased with higher doses of BI 456906, with decreased appetite being the most common in the phase Ia study.
- In the phase Ib study, 12.5% and 17.8% of participants discontinued treatment in Parts A and B, mainly due to adverse events.
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