Overview
A Research Study Looking at the Safety of Multiple Doses of ZP8396 and How it Works in the Body of Healthy Participants
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-07-01
2023-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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 placeboPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Zealand Pharma
Criteria
Inclusion Criteria:- 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
Exclusion Criteria:
- History of metabolic diseases more frequently associated with obesity, e.g.
type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
- Systolic blood pressure below 90 mmHg or above139 mmHg and/or diastolic blood pressure
below 50 mmHg or above 89 mmHg
- Symptoms of arterial hypotension
- Further exclusion criteria apply