Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial
Authors' conclusion
Eloralintide produced clinically meaningful, dose-dependent reductions in bodyweight over 48 weeks and was generally well tolerated, supporting eloralintide's potential use for obesity treatment.
Study context
- Population
- Adults aged 18–75 years with BMI ≥30 kg/m², or ≥27 kg/m² with ≥1 weight-related comorbidity, without T2D; 46 centres in the USArandomised 2:1:1:1:2:1:2
- Participants
- 263 adults
- Comparison
- Once-weekly eloralintide vs placebo
- 1 mgn = 28
- 3 mgn = 24
- 6 mgn = 28
- 9 mgn = 54
- 6-9 mgn = 24
- 3-9 mgn = 52
- Placebon = 53reference
- Primary endpoint
- Percent change in bodyweight from baseline
- Follow-up
- 48 weeks
Methodological detailsphase 2, multicentre, double-blind, placebo-controlled, dose-ranging
- Phase 2
- Multicentre
- Double-blind
- Placebo-controlled
- Dose-ranging
Primary result
As reported in the abstract
Mean percent change in bodyweight (efficacy estimand)
1 mg
−9%
mean · 95% CI −12.6–-6.3
3 mg
−12%
mean · 95% CI −14.9–-9.8
6 mg
−18%
mean · 95% CI −20.7–-14.5
9 mg
−20%
mean · 95% CI −22.7–-17.5
6-9 mg
−20%
mean · 95% CI −22.7–-17.0
3-9 mg
−16%
mean · 95% CI −18.6–-14.1
Placebo
−0.4%
mean · 95% CI −2.2–1.4
Safety
| Outcome | Values |
|---|---|
| NauseaMost common AE with eloralintide | 1 mg 11% · 3 mg 13% · 6 mg 64% · 9 mg 33% · 6-9 mg 54% · 3-9 mg 25% · Placebo 14% |
| FatigueMost common AE with eloralintide | 1 mg 0% · 3 mg 13% · 6 mg 29% · 9 mg 43% · 6-9 mg 46% · 3-9 mg 21% · Placebo 12% |
Original publication
Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. Published 6 November 2025. doi:10.
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