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

An Open-label, Randomized, Parallel-group, Single-center Trial to Compare Pharmacokinetics of Dapiglutide After a Single Subcutaneous Dose of the Drug Product Concentrations 10 mg/mL or 25 mg/mL in Participants With Overweight or Obesity

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Drug: Dapiglutide 7.5 mg

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Neuss, North Rhine-Westphalia, Germany, 41460
      • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapiglutide 10 mg/mL; Single dose, s.c. administration	Drug: Dapiglutide 7.5 mg; Single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL.
Experimental: Dapiglutide 25 mg/mL; Single dose, s.c. administration	Drug: Dapiglutide 7.5 mg; Single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	Trial Day 1 to 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide	Area under the dapiglutide plasma concentration-time curve from time zero to last measurable concentration after a single 7.5 mg dose of dapiglutide (AUC0-t)	Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide	Time to maximum observed dapiglutide plasma concentration after a single 7.5 mg dose of dapiglutide (Tmax)	Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide	Terminal elimination half-life for dapiglutide after a single 7.5 mg dose of dapiglutide (t½)	Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide	Elimination rate constant for dapiglutide after a single 7.5 mg dose of dapiglutide (λz)	Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide	Apparent clearance of dapiglutide after a single 7.5 mg dose of dapiglutide (CL/F)	Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide	Apparent volume of distribution during terminal phase of dapiglutide after a single 7.5 mg dose of dapiglutide (Vz/f)	Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide	Mean residence time of dapiglutide after a single 7.5 mg dose of dapiglutide (MRT)	Day 1 to 28
To investigate the safety and tolerability of a single dose administration of 7.5 mg dapiglutide	Incidence of treatment emergent adverse events (TEAEs) from dosing (Day 1) to end of trial (Day 42).	Day 1 to 42

Collaborators and Investigators

• Sponsor: Zealand Pharma
• Collaborators: Profil Institut für Stoffwechselforschung GmbH
• Investigators: Principal Investigator: Ulrike Hoevelmann, MD, Profil, Neuss

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2024
• Primary Completion (Actual): April 12, 2025
• Study Completion (Actual): April 25, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: obesity; overweight; weight management; GLP-1R/GLP-2RA
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: ZP7570-24026; 2024-516901-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data collection and handling of clinical trial data at the trial site has been designed to limit the possibility of identifying trial subjects from their data. To this end, pseudonymised data will be used wherever possible and the collection of demographic information that could be used for re-identification of subjects will be restricted to the extent necessary for the conduct of this trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No