The safety, tolerability, pharmacokinetics and pharmacodynamics of an optimized dual GLP ‐1/ GIP receptor agonist ( BGM0504 ) in healthy volunteers: A dose‐escalation Phase I study
Authors' conclusion
BGM0504 was generally safe and well tolerated with favourable PK profile and potential role in weight loss was also confirmed. These findings support subsequent development of BGM0504 for type 2 diabetes mellitus (T2DM) and obesity.
Study context
- Population
- Chinese healthy volunteersreceived ≥1 dose
- Participants
- 40 volunteers
- Comparison
- BGM0504 vs placebo
- Primary endpoint
- Safety, tolerability, PK and pharmacodynamics (PD)
Methodological detailsdouble-blind, placebo-controlled, dose-escalation, phase I
- Double-blind
- Placebo-controlled
- Dose-escalation
- Phase I
Primary result
As reported in the abstract
PK
- Pharmacokinetics (PK) profile supported once-weekly administration
- Cmax and AUC linearly proportional to dose from 2.5-15 mg
Further findings
| Outcome | 2.5 mg | 5 mg | 10 mg | 15 mg |
|---|---|---|---|---|
| Change in body weight (%) from baseline | −3.24% | −6.26% | −7.09% | - 8.30% |
Change in body weight (%) from baseline
- Greater weight change with BGM0504 than placebo, with a certain dose correlation
Glycaemic control
- Potential roles of BGM0504 in glycaemic control observed
Safety
Adverse events
- Most frequent AEs gastrointestinal (vomiting, nausea, decreased appetite, diarrhoea, abdominal distension)
Original publication
The safety, tolerability, pharmacokinetics and pharmacodynamics of an optimized dual GLP ‐1/ GIP receptor agonist ( BGM0504 ) in healthy volunteers: A dose‐escalation Phase I study. Diabetes Obes Metab. Published 22 January 2025. doi:10.
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