Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
Authors' conclusion
In adults with obesity or overweight without diabetes (type 1 or 2), individuals administered ecnoglutide had superior and sustained reduction in bodyweight versus placebo with a favourable safety profile, supporting its potential use for weight management.
Study context
- Population
- Chinese adults aged 18–75 years with overweight or obesity (BMI ≥28 kg/m² or ≥24 kg/m² with ≥1 weight-related comorbidity), without diabetes; 36 centres in Chinarandomized 3:3:3:1:1:1
- Participants
- 664 adults
- Comparison
- Once-weekly subcutaneous ecnoglutide vs placebo
- Ecnoglutide 1.2 mgn = 166
- Ecnoglutide 1.8 mgn = 166
- Ecnoglutide 2.4 mgn = 167
- Placebon = 165reference
- Primary endpoint
- Coprimary: percentage change in bodyweight and proportion with bodyweight reduction ≥5%
- Follow-up
- Week 40
Methodological detailsmulticentre, double-blind, placebo-controlled, phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- Phase 3
Primary result
As reported in the abstract
Percentage change in bodyweight (LS mean)
Ecnoglutide 1.2 mg
−9.1
least-squares mean · SE 0.8 · %
Ecnoglutide 1.8 mg
−10.9
least-squares mean · SE 0.9 · %
Ecnoglutide 2.4 mg
−13.2
least-squares mean · SE 0.8 · %
Placebo
0.1
least-squares mean · SE 0.8 · %
Each group vs placeboEstimated treatment difference, % (97% CI)P value
Ecnoglutide 1.2 mg
−9.2(−11.0 to −7.5)
P < 0.0001Ecnoglutide 1.8 mg
−11.1(−13.1 to −9.1)
P < 0.0001Ecnoglutide 2.4 mg
−13.3(−15.3 to −11.3)
P < 0.0001Further findings
| Outcome | Ecnoglutide 1.2 mg | Ecnoglutide 1.8 mg | Ecnoglutide 2.4 mg | Placebo | Estimated treatment difference (%) (98% CI) | P value | |
|---|---|---|---|---|---|---|---|
| Coprimary: bodyweight reduction ≥5% · week 40Ecnoglutide 1.2 mgvs PlaceboTreatment policy estimand, full analysis set | 77% | 84% | 87% | 16% | 60 (50–71) | P < 0.0001 | |
| Coprimary: bodyweight reduction ≥5% · week 40Ecnoglutide 1.8 mgvs PlaceboTreatment policy estimand, full analysis set | 68 (58–78) | P < 0.0001 | |||||
| Coprimary: bodyweight reduction ≥5% · week 40Ecnoglutide 2.4 mgvs PlaceboTreatment policy estimand, full analysis set | 70 (61–80) | P < 0.0001 | |||||
| −50050100Difference, % (linear scale) |
Safety
Treatment-emergent adverse events
- Treatment-emergent adverse events — Ecnoglutide-treated participants discontinuing due to adverse events
- 10
Treatment-emergent adverse events
- Most common adverse events were mild-to-moderate gastrointestinal events
Original publication
Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. Published 21 June 2025. doi:10.
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