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

Dapiglutide is a dual Glucagon-like peptide-1-/Glucagon-like peptide-2 Receptor Agonist (GLP-1R/GLP-2RA) in clinical development for weight management. The purpose of this phase 1 trial is to compare pharmacokinetics (PK) of a single dose administration of 7.5 mg dapiglutide administered subcutaneously (s.c.) with two drug product concentrations, 10 mg/mL and 25 mg/mL and will be conducted in 30 participants with a body mass index (BMI) ≥ 27.0 kg/m2. The development of a drug product with higher drug concentration will facilitate investigation of a wider dose range of dapiglutide in the clinical development program of the compound. The PK profile of a weight management drug should be assessed in people with a wide range of BMI and with a BMI within the range of the target population as body weight is expected to influence PKs of dapiglutide.

Inclusion criteria

• Age between 18 and 64 years, both inclusive,
• BMI >= 27.0 kg/m^2
• HbA1c < 6.5 %.

Exclusion criteria

• Any history or presence of a disorder or a disease, which, in the investigator's opinion, might jeopardize participant's safety, evaluation of results or compliance with the protocol, treatment with dapiglutide (any exposure) or any other drugs, including dual and tri agonists, involving a GLP-1 RA or GLP-2 RA within 180 days prior to screening.
• Any medication (prescription and non-prescription drugs) with the exception of stable treatment with antihypertensive and lipid-lowering drugs as well as thyroid replacement therapy.
• Female participants of childbearing potential who are not willing to use highly effective contraception until 42 days after dosing