Safety, Pharmacokinetics and Pharmacodynamics of the GLP ‐1/ GIP / GCG Receptor Agonist UBT251 Injection: A Randomized, Placebo‐Controlled Phase 1a/1b Study
Authors' conclusion
UBT251 demonstrated an acceptable safety profile and predictable pharmacokinetic properties, accompanied by substantial weight reduction and meaningful metabolic improvements.
Study context
- Population
- Phase 1b: participants with overweight or obesity without DM
- Comparison
- UBT251 vs placebo
- Primary endpoint
- Safety and tolerability
Methodological detailsfirst-in-human, phase 1a/1b, double-blind, placebo-controlled, single-ascending-dose (phase 1a), multiple-ascending-dose (phase 1b)
- First-in-human
- Phase 1a/1b
- Double-blind
- Placebo-controlled
- Single-ascending-dose (phase 1a)
- Multiple-ascending-dose (phase 1b)
Primary result
As reported in the abstract
- UBT251 was generally well tolerated; most common adverse effects were laboratory investigations, decreased appetite and gastrointestinal adverse events
Further findings
| Outcome | UBT251 | Placebo |
|---|---|---|
| Body weight change, overweight or obesity (phase 1b) · 12 weeks | mean 8.96-13.48 kg | 1.57 kg |
- Body weight change, overweight or obesity (phase 1b): UBT251 1, 3 and 6 mg: mean reduction; placebo: increase
Pharmacokinetics
- Approximately linear PK across the 1.0-6.0 mg dose range after single and multiple dosing
Metabolic effects
- Reductions in FPG, HbA1c and lipid parameters with UBT251
Safety
Adverse events
- Most common adverse effects: laboratory investigations, decreased appetite and gastrointestinal AEs
Original publication
Safety, Pharmacokinetics and Pharmacodynamics of the GLP ‐1/ GIP / GCG Receptor Agonist UBT251 Injection: A Randomized, Placebo‐Controlled Phase 1a/1b Study. Diabetes Obes Metab. Published 8 September 2026. doi:10.
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