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

Phase 1

Completed

• Conditions: Overweight and Obesity
• Interventions: Drug: Dapiglutide 7.5 mg

• Registration Number: NCT06758583
• Lead Sponsor: Zealand Pharma

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-12-09
• Study Start: 2024-12-23
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-06
• Primary Completion: 2025-04-12
• Study Completion: 2025-04-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapiglutide 10 mg/mL	Dapiglutide 7.5 mg	Single dose, s.c. administration
Dapiglutide 25 mg/mL	Dapiglutide 7.5 mg	Single dose, s.c. administration

Primary Outcome Measures

Name	Time	Method
To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide	Trial Day 1 to 28	Maximum observed dapiglutide plasma concentration after a single 7.5 mg dose of dapiglutide (Cmax)

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide	Day 1 to 28	Mean residence time of dapiglutide after a single 7.5 mg dose of dapiglutide (MRT)
To investigate the safety and tolerability of a single dose administration of 7.5 mg dapiglutide	Day 1 to 42	Incidence of treatment emergent adverse events (TEAEs) from dosing (Day 1) to end of trial (Day 42).

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, North Rhine-Westphalia, Germany