A randomized Phase I study of the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 456906, a dual glucagon receptor/glucagon‐like peptide‐1 receptor agonist, in healthy Japanese men with overweight/obesity
Authors' conclusion
BI 456906 showed no unexpected tolerability concerns and it reduced placebo-corrected bodyweight by up to 12.37% in Japanese men with overweight/obesity after 16 weeks of treatment.
Study context
- Population
- Healthy Japanese men with overweight/obesity, BMI 23 to 40 kg/m²treated
- Participants
- 36 men
- Comparison
- BI 456906 vs placebo
- DG 1n = 9
- DG 2n = 9
- DG 3n = 9
- Placebon = 9reference
Methodological detailsphase I, placebo-controlled, multiple rising doses
- Phase I
- Placebo-controlled
- Multiple rising doses
Primary result
As reported in the abstract
Placebo-corrected bodyweight change · 16 weeks
DG 1
−5.57%
DG 2
−12.37%
DG 3
−9.62%
Placebo
+1.06%
Further findings
Pharmacokinetics
- BI 456906 exposure increased with dose and dose escalation in each DG
Paracetamol absorption · Week 1
- Decreased for DGs 2 and 3, indicating transient delayed gastric emptying
Plasma alanine and glucagon
- Reduced by BI 456906, indicating indirect target engagement at GCGRs and GLP-1Rs
Safety
| Outcome | DG 1 | DG 2 | DG 3 | Placeboevents |
|---|---|---|---|---|
| Withdrawal from dose escalation due to adverse events | 22.2% | 66.7% | 22.2% | 0 |
| Drug-related adverse events | — not stated in the abstract | — not stated in the abstract | — not stated in the abstract | 4 |
— not stated in the abstract
- Withdrawal from dose escalation due to adverse events — Overall BI 456906 withdrawals
- 10 (37.0%)
- Withdrawal from dose escalation due to adverse events — Amylase increase
- n = 1
- Withdrawal from dose escalation due to adverse events — Decreased appetite
- n = 9
- Drug-related adverse events — Most frequent: decreased appetite
- n = 24, 66.7%
Drug-related adverse events
- Reported for all participants receiving BI 456906
Original publication
A randomized Phase I study of the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 456906, a dual glucagon receptor/glucagon‐like peptide‐1 receptor agonist, in healthy Japanese men with overweight/obesity. Diabetes Obes Metab. Published 27 April 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →