Clinical trial NCT06758583: A Trial Comparing Pharmacokinetics, Safety and Tolerability of Two Subcutaneous Concentrations of Dapiglutide
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight and Obesity
Keywords: GLP-1R/GLP-2RA
overweight
obesity
weight management
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
Collaborators: name: Profil Institut für Stoffwechselforschung GmbH
First posted: 2025-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide
timeFrame: Trial Day 1 to 28
measure: To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide
timeFrame: Trial Day 1 to 28
Secondary outcomes:
measure: To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
timeFrame: Day 1 to 28
measure: To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
timeFrame: Day 1 to 28
measure: To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
timeFrame: Day 1 to 28
measure: To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
timeFrame: Day 1 to 28
measure: To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
timeFrame: Day 1 to 28
measure: To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
timeFrame: Day 1 to 28
measure: To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
timeFrame: Day 1 to 28
measure: To investigate the safety and tolerability of a single dose administration of 7.5 mg dapiglutide
timeFrame: Day 1 to 42
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
state: North Rhine-Westphalia
Study officials:
affiliation: Profil, Neuss
name: Ulrike Hoevelmann, MD
role: PRINCIPAL_INVESTIGATOR
References: