Part 1: To investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 3034701 in Japanese male and female participants with body mass index (BMI) ≥27.0 kg/m² or more following subcutaneous administration of multiple rising doses over 16 weeks. Part 2: To investigate safety, tolerability, and PK of BI 3034701 in Japanese male and female healthy participants with BMI ≥23.0 to \<27.0 kg/m² following subcutaneous administration of multiple rising doses over 7 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
BI 3034701
Placebo
SOUSEIKAI Hakata Clinic
Fukuoka, Fukuoka, Japan
Fukuoka Mirai Hospital
Fukuoka, Fukuoka, Japan
SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, Japan
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Expressed as the percentage of trial participants treated with investigational drug who experience such an event
Time frame: Part 1: up to Week 19, Part 2: up to Week 10
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) following a single dose and multiple doses of BI 3034701
Time frame: Part 1: up to Week 17, Part 2: up to Week 8
Maximum measured concentration of the analyte in plasma (Cmax) following a single dose and multiple doses of BI 3034701
Time frame: Part 1: up to Week 19, Part 2: up to Week 10
Change from baseline in body weight at the end of 16 weeks treatment (only evaluated for Part 1)
Time frame: Part 1: at Baseline and at Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.