Safety, pharmacokinetics and pharmacodynamics of Efsubaglutide Alfa in healthy participants: A randomised, dose‐escalation phase 1 study
Authors' conclusion
Efsubaglutide Alfa was well tolerated in healthy participants, with a favourable PK and PD profiles that support further clinical development in type 2 diabetes and metabolic disorders.
Study context
- Population
- Healthy adults, single centrerandomised 6:2
- Participants
- 48 adults
- Comparison
- Single-dose subcutaneous Efsubaglutide Alfa vs placebo
- Primary endpoint
- Safety, PK and Pharmacodynamics (PD) of single-dose subcutaneous Efsubaglutide Alfa
Methodological detailsphase 1, double-blind, placebo-controlled, single-dose escalation, single-centre
- Phase 1
- Double-blind
- Placebo-controlled
- Single-dose escalation
- Single-centre
Primary result
As reported in the abstract
PK of Efsubaglutide Alfa
Dose-proportional pharmacokinetics (PK); median Tmax
47.5-71.7 h
Mean half-life (T1/2)
121.4 h
Exposure increased linearly across doses; Cmax
37.1-832.4 ng/mL
AUC0-∞
8699.6-193446.6 ng/mL·h
Further findings
| Outcome | Glucose AUC (mmol/L·2 h) | P value |
|---|---|---|
| OGTT glucose excursions · Day 2Lower with Efsubaglutide Alfa | ≈0.7 | P = 0.0150 |
FPG · Day 1 to Day 28
- Transiently declined on Day 1, returned to baseline by Day 2; change from baseline through Day 28 (within expected physiological variability)
- −0.8 to +1.9 mmol/L
Fasting insulin and C-peptide
- Slightly increased on Day 1, normalised by Day 2, and remained stable
OGTT glucose excursions · Day 2
- Insulin and C-peptide levels remained unchanged
Body weight · peak Day 4-7
- Dose-dependent weight loss, up to reduction at the higher dose (p < 0.0001), gradual return towards baseline by Day 28
- 4.0%
Safety
- Serious AEs
- 0
- Mild-to-moderate gastrointestinal AEs (nausea, vomiting, decreased appetite) most common with Efsubaglutide Alfa
Original publication
Safety, pharmacokinetics and pharmacodynamics of Efsubaglutide Alfa in healthy participants: A randomised, dose‐escalation phase 1 study. Diabetes Obes Metab. Published 5 June 2025. doi:10.
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