Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials
Authors' conclusion
Petrelintide appeared safe, had a low incidence of GI TEAEs, and resulted in clinically relevant weight loss.
Study context
- Population
- Single ascending dose (SAD) and multiple ascending dose (MAD) part 1: normal or overweight adults; MAD part 2: adults with overweight or obesity
- Comparison
- Petrelintide vs placebo
- Primary endpoint
- Safety, tolerability, pharmacokinetics and pharmacodynamics
Methodological detailsphase 1 SAD and MAD trials, randomized, placebo-controlled, double-blind, single ascending dose, multiple ascending dose
- Phase 1 SAD and MAD trials
- Randomized
- Placebo-controlled
- Double-blind
- Single ascending dose
- Multiple ascending dose
Primary result
As reported in the abstract
- Petrelintide was well tolerated, with no serious or severe treatment-emergent adverse events (TEAEs)
- Most common TEAEs were gastrointestinal (GI) disorders, most of which were mild
Safety
| Outcome | Petrelintide | Placebo |
|---|---|---|
| Nausea (most common GI TEAE), MAD part 2 | 16.7%-33.3% | 16.7% |
Other TEAEs
- Discontinued treatment due to GI TEAEs
- 1 participant
- Most common TEAEs in both trials included GI disorders, mostly mild
- Diarrhoea was rare; vomiting only in the participant who discontinued
Original publication
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials. Diabetes Obes Metab. Published 22 April 2026. doi:10.
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