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

Zealand Pharma

Status and phase: Completed; Phase 1

Conditions: Overweight and Obesity

Treatments: Drug: Dapiglutide 7.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06758583

ZP7570-24026

2024-516901-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Dapiglutide 10 mg/mL

Experimental group

Description:

Single dose, s.c. administration

Treatment:

Drug: Dapiglutide 7.5 mg

Dapiglutide 25 mg/mL

Experimental group

Description:

Single dose, s.c. administration

Treatment:

Drug: Dapiglutide 7.5 mg