NCT05613387CompletedPhase 1
A Research Study Looking at the Safety of Multiple Doses of ZP8396 and How it Works in the Body of Healthy Participants
A Randomized, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects
Source: ClinicalTrials.gov · Last updated 18 Jun 2024
Brief summary (registry, in English)
The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial in normal weight and overweight but otherwise healthy subjects randomised to subcutaneous administration of ZP8396 or placebo
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 68 (actual)
- First submitted
- 28 Oct 2022
- Start date
- 7 Nov 2022
- Primary completion date
- 13 Jun 2024
- Lead sponsor
- Zealand Pharma
- Diseases
- Obesity
- NCT number
- NCT05613387
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 68
- From 7 Nov 2022 to the primary completion date, 13 Jun 2024
- 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.
Other illness
- History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
- History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
Other
- Part 1:
- Systolic blood pressure below 90 mmHg or above 139 mmHg and/or diastolic blood pressure below 50 mmHg or above 89 mmHg
- Symptoms of arterial hypotension
- Further exclusion criteria apply
- Part 2:
- Systolic blood pressure below 90 mmHg or above 159 mmHg and/or diastolic blood pressure below 50 mmHg or above 99 mmHg
- Symptoms of arterial hypotension
- Further exclusion criteria apply
Who the study is looking for
- Part 1:
- Body Mass Index (BMI) between 21.0 and 29.9 kg/m\^2, both inclusive
- Glycosylated hemoglobin (HbA1c) below 5.7 percent
- Further inclusion criteria apply
- Part 2:
- Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2, both inclusive
- Glycosylated hemoglobin (HbA1c) below 6.5 percent
- Further inclusion criteria apply
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.