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
Overview
- Phase
- Phase 1
- Intervention
- Dapiglutide 7.5 mg
- Conditions
- Overweight and Obesity
- Sponsor
- Zealand Pharma
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide
- Status
- Completed
- Last Updated
- 12 months ago
Overview
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.
Investigators
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
Arms & Interventions
Dapiglutide 25 mg/mL
Single dose, s.c. administration
Intervention: Dapiglutide 7.5 mg
Dapiglutide 10 mg/mL
Single dose, s.c. administration
Intervention: Dapiglutide 7.5 mg
Outcomes
Primary Outcomes
To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide
Time Frame: Trial Day 1 to 28
Maximum observed dapiglutide plasma concentration after a single 7.5 mg dose of dapiglutide (Cmax)
Secondary Outcomes
- To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide(Day 1 to 28)
- To investigate the safety and tolerability of a single dose administration of 7.5 mg dapiglutide(Day 1 to 42)