Healthy, Obesity
Conditions
Brief summary
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.
Interventions
DRUGBI 3034701
BI 3034701
DRUGPlacebo
Placebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
: 1. Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \< 10 years, and have parents and grandparents who are Japanese 2. Part 1: Male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests 3. Part 2: Healthy male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests 4. Parts 1 and 2: Age of 18 to 64 years (inclusive) 5. Further inclusion criteria apply.
Exclusion criteria
: 1. Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and, in particular: alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%, aspartate aminotransferase (AST) above ULN + 20%, gamma-glutamyl transferase (GGT) above ULN + 20%, Lipase or amylase above ULN + 20%, bilirubin above 1.2x ULN (except for cases of Gilbert's Syndrome), estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m² 4. Part 1: Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening 5. Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator | Part 1: up to Week 19, Part 2: up to Week 10 | Expressed as the percentage of trial participants treated with investigational drug who experience such an event |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 | 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) | Part 1: at Baseline and at Week 16 |
Countries
Japan
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed