Overweight and Obesity
Conditions
Keywords
GLP-1R/GLP-2RA, overweight, obesity, weight management
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.
Interventions
DRUGDapiglutide 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.
Sponsors
Profil Institut für Stoffwechselforschung GmbH
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide | Trial Day 1 to 28 | Area under the dapiglutide plasma concentration-time curve from time zero to infinity after a single 7.5 mg dose of dapiglutide (AUC0-inf). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide | Day 1 to 28 | 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) |
| 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). |
Countries
Germany
Outcome results
None listed