A Trial Comparing Pharmacokinetics, Safety and Tolerability of Two Subcutaneous Concentrations of Dapiglutide

Phase 1 Completed 30 enrolled Zealand Pharma Profil Institut für Stoffwechselforschung GmbH · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 1, open-label, single-center, randomized, parallel-group trial designed to investigate the pharmacokinetic profiles, safety, and tolerability of a single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL. The trial will be conducted in participants with a BMI ≥ 27.0 kg/m2.

Timeline

Start: 2024-12-23
Primary completion: 2025-04-12
Completion: 2025-04-25

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapiglutide	Protein / enzyme biologic	7.5 mg	Subcutaneous

Indications

No indication recorded.