Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study
Authors' conclusion
In people with overweight or obesity, once-weekly subcutaneous amycretin up to 60 mg had a safety and tolerability profile consistent with GLP-1 and amylin agonists. Although a high frequency of gastrointestinal events was reported, rates were similar to those seen in early-phase studies of these molecules. These results support further investigation into the weight loss properties of amycretin.
Study context
- Population
- Participants aged 18–55 years with overweight or obesity (BMI 27.0–39.9 kg/m²), single clinical research centre in San Antonio, TX, USA
- Participants
- 125 participants
- Comparison
- Once-weekly SC amycretin vs placebo
- Amycretinn = 101
- Placebon = 24reference
- Primary endpoint
- Number of treatment-emergent adverse events (Parts A-E)
- Follow-up
- Baseline to end of study
Methodological detailsplacebo-controlled, phase 1b/2a, masked, single-centre, single and multiple ascending dose, A large number of participants withdrew; a high proportion of discontinuations were for reasons unrelated to treatment-emergent adverse events
- Placebo-controlled
- Phase 1b/2a
- Masked
- Single-centre
- Single and multiple ascending dose
- A large number of participants withdrew; a high proportion of discontinuations were for reasons unrelated to treatment-emergent adverse events
Primary result
As reported in the abstract
Treatment-emergent adverse events
- Most common treatment-emergent adverse events were gastrointestinal; majority mild to moderate and resolved by end of study
Secondary outcomes
Mean
| Outcome | Amycretin | Placebo | P value |
|---|---|---|---|
| Estimated mean bodyweight change from baseline, Part B (60 mg) · week 36 | −24.3% | −1.1% | P < 0.0001 |
| Estimated mean bodyweight change from baseline, Part C (20 mg) · week 36 | −22.0% | 1.9% | P < 0.0001 |
| Estimated mean bodyweight change from baseline, Part D (5 mg) · week 28 | −16.2% | 2.3% | P < 0.0001 |
| Estimated mean bodyweight change from baseline, Part E (1.25 mg) · week 20 | −9.7% | 2.0% | P = 0.0003 |
Safety
- Most common treatment-emergent adverse events were gastrointestinal, mostly mild to moderate, resolved by end of study
Original publication
Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study. Lancet. Published 20 June 2025. doi:10.
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