NCT06758583CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 9 Dec 2024
- Start date
- 23 Dec 2024
- Primary completion date
- 12 Apr 2025
- Lead sponsor
- Zealand Pharma
- Diseases
- Obesity
- NCT number
- NCT06758583
- EudraCT number
- 2024-516901-21
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 23 Dec 2024 to the primary completion date, 12 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Female participants of childbearing potential who are not willing to use highly effective contraception until 42 days after dosing
Who the study is looking for
- Age between 18 and 64 years, both inclusive,
- BMI \>= 27.0 kg/m\^2
- HbA1c \< 6.5 %.
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH Coordinator of this site? Confirm its status | Neuss | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.