Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial
Authors' conclusion
In people with overweight or obesity, amycretin appeared safe and tolerable. Results from this first-in-human, phase 1 study support further investigation of the weight loss properties of amycretin.
Study context
- Population
- Adults aged 18–55 years with overweight or obesity (BMI 25.0–34.9 kg/m² parts A and B; 27.0–39.9 kg/m² part C/D), single clinical research unit, San Antonio (TX, USA)48 part A, 36 part B, 60 part C/D
- Participants
- 144 adults
- Comparison
- Oral amycretin vs placebo
- Primary endpoint
- Number of treatment-emergent adverse events
- Follow-up
- Day 1 to end-of-study visit on day 22 (part A), day 31 (part B), or day 105 (part C/D)
Methodological detailsphase 1, first-in-human, double-blind, placebo-controlled, multipart, single-centre, single and multiple ascending doses, Enrolment May 11, 2022 to Jan 9, 2024
- Phase 1
- First-in-human
- Double-blind
- Placebo-controlled
- Multipart
- Single-centre
- Single and multiple ascending doses
- Enrolment May 11, 2022 to Jan 9, 2024
Primary result
As reported in the abstract
Treatment-emergent adverse events, parts A-D
Treatment-emergent adverse events
364 events in 89 (62%) of 144 participants
Gastrointestinal events
180 [49%] of 364 events
Participants with a treatment-emergent adverse event who had gastrointestinal events
72 (81%) of 89
Deaths
0
Further findings
Pharmacokinetics
- Amycretin plasma concentrations consistent with dose proportionality across all treatment groups
Safety
- Treatment-emergent adverse events
- 364 events in 89 (62%) of 144 participants
- Gastrointestinal events
- 180 [49%] of 364 events
- Deaths
- 0
Original publication
Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial. Lancet. Published 20 June 2025. doi:10.
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