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

Zealand Pharma30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overweight and Obesity

Interventions

Dapiglutide 7.5 mgDRUG

Single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide

Area under the dapiglutide plasma concentration-time curve from time zero to infinity after a single 7.5 mg dose of dapiglutide (AUC0-inf).

Time frame: Trial Day 1 to 28

To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide

Maximum observed dapiglutide plasma concentration after a single 7.5 mg dose of dapiglutide (Cmax)

Time frame: Trial Day 1 to 28