A randomized phase I study of BI 1820237, a novel neuropeptide Y receptor type 2 agonist, alone or in combination with low‐dose liraglutide in otherwise healthy men with overweight or obesity
Authors' conclusion
BI 1820237 treatment was associated with transient nausea and vomiting at higher doses. No differences in tolerability were observed when combined with liraglutide; effects on gastric emptying appeared additive.
Study context
- Population
- Otherwise healthy men with increased body mass index (BMI) (25.0–34.9 kg/m²)randomized
- Participants
- 95 men
- Comparison
- BI 1820237 alone or with low-dose liraglutide vs placebo
- Primary endpoint
- Proportion of participants with drug-related AEs
Methodological detailsfirst-in-human, three-part, partially blinded, phase I, single ascending doses
- First-in-human
- Three-part
- Partially blinded
- Phase I
- Single ascending doses
Primary result
As reported in the abstract
Drug-related AEs (mainly gastrointestinal)
Drug-related adverse events (AEs), parts 1 + 2
39.0%
n = 23
Drug-related AEs, part 3
30.6%
n = 11
Drug-related AE with placebo + liraglutide (part 3)
1
11.1%
Secondary outcomes
Gastric emptying (post-dose paracetamol pharmacokinetics (PK))
- BI 1820237 and low-dose liraglutide suggested additive effects on gastric emptying
Safety
- Drug-related AEs, mainly gastrointestinal, parts 1 + 2
- 39.0% (n = 23)
- Drug-related AEs, part 3
- 30.6% (n = 11)
- Transient nausea and vomiting at higher BI 1820237 doses
Original publication
A randomized phase I study of BI 1820237, a novel neuropeptide Y receptor type 2 agonist, alone or in combination with low‐dose liraglutide in otherwise healthy men with overweight or obesity. Diabetes Obes Metab. Published 7 October 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →