Obesity
Conditions
Brief summary
Frequency, seriousness and intensity of adverse events (AEs)., Clinically significant changes from baseline in vital signs (blood pressure, pulse and body temperature), ECG, clinical laboratory measurements (haematology, clinical chemistry, coagulation) and physical examination findings.
Detailed description
Change from baseline to after 4, 8 and 12 weeks of dosing with XEN-D0501 on: body weight (mean absolute and percentage change), body composition (fat mass, fat-free mass) (change to week 12 only), waist and hip circumference, waist height ratio and waist hip ratio, Change from baseline to after 4, 8 and 12 weeks of dosing with XEN-D0501 on (including but not limited to): blood lipids, FPG, FI, HbA1c, Part 1: Plasma levels of XEN-D0501, and PK parameters (full profile, as applicable).
Interventions
DRUGPlacebo formulation contains the same excipients and is identical to XEN-D0501 in terms of appearance.
DRUGXEN-D0501
Sponsors
Pila Pharma AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, seriousness and intensity of adverse events (AEs)., Clinically significant changes from baseline in vital signs (blood pressure, pulse and body temperature), ECG, clinical laboratory measurements (haematology, clinical chemistry, coagulation) and physical examination findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to after 4, 8 and 12 weeks of dosing with XEN-D0501 on: body weight (mean absolute and percentage change), body composition (fat mass, fat-free mass) (change to week 12 only), waist and hip circumference, waist height ratio and waist hip ratio, Change from baseline to after 4, 8 and 12 weeks of dosing with XEN-D0501 on (including but not limited to): blood lipids, FPG, FI, HbA1c, Part 1: Plasma levels of XEN-D0501, and PK parameters (full profile, as applicable). | — |
Outcome results
None listed