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NCT05613387
A Research Study Looking at the Safety of Multiple Doses of ZP8396 and How it Works in the Body of Healthy Participants
Conditions: Overweight, Healthy Volunteers
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 30
Sponsor: Zealand Pharma
Location: Germany
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 placebo
Eligibility Criteria
Inclusion Criteria:Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusiveGlycosylated hemoglobin (HbA1c) below 5.7 percentFurther inclusion criteria applyExclusion Criteria:History of metabolic diseases more frequently associated with obesity, e.g.
type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or strokeSystolic blood pressure below 90 mmHg or above139 mmHg and/or diastolic blood pressure below 50 mmHg or above 89 mmHgSymptoms of arterial hypotensionFurther exclusion criteria apply
Source: ClinicalTrials.gov (NCT05613387). StuddyBuddy aggregates publicly available trial information.