A Phase 1, Randomised, Double‐Blind, Placebo‐Controlled Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN069 (a Dual GLP ‐ 1R Agonist and GIPR Antagonist) in Male Adults With Overweight or Obesity
Authors' conclusion
KN069 exhibits favourable safety, long-acting PK and preliminary dose-dependent weight reduction alongside expected pharmacologic metabolic effects
Study context
- Population
- Chinese men with overweight/obesity
- Participants
- 36 vs 12
- Comparison
- KN069 vs placebo
- Single ascending dose (SAD)n = 36
- Multiple ascending dose (MAD)n = 12
- Primary endpoint
- Safety and tolerability (AEs and compliance)
Methodological detailsphase 1, first-in-human, double-blind, placebo-controlled, single ascending dose, multiple ascending dose
- Phase 1
- First-in-human
- Double-blind
- Placebo-controlled
- Single ascending dose
- Multiple ascending dose
Primary result
As reported in the abstract
Safety and tolerability
- KN069 was well tolerated, with predominantly mild-to-moderate gastrointestinal adverse events (AEs)
Further findings
| Outcome | Values |
|---|---|
| Body weight change, SAD part · Day 7 | 90 mg −4.71% · Placebo −0.41% |
| Mean weight change from baseline, MAD part · Day 25 | Group B (60 mg) mean −2.57% |
Pharmacokinetics (PK) of Total KN069
- Half-life of Total KN069
- 899.74-1099.01 h
- Dose-proportional exposure (12-90 mg)
Body weight change, SAD part · Day 7
- Preliminary dose-dependent weight reductions, sustained for up to 133 days
Waist circumference, MAD Group B (60 mg) · Day 25
- Significant decrease in waist circumference
- P = 0.0446
Metabolic parameters
- Lower fasting glucose, TG, uric acid and elevated insulin/C-peptide
Safety
- Well tolerated; predominantly mild-to-moderate gastrointestinal AEs
Original publication
A Phase 1, Randomised, Double‐Blind, Placebo‐Controlled Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN069 (a Dual GLP ‐ 1R Agonist and GIPR Antagonist) in Male Adults With Overweight or Obesity. Diabetes Obes Metab. Published 20 April 2026. doi:10.
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