Clinical trial

A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Japanese Healthy People and Japanese People With Obesity or Overweight

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07693231

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years
SexAll
Healthy volunteersAccepted
ConditionHealthy, Obesity

Full registry criteria

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 exclusion criteria apply.

Treatments and study arms

BI 3034701

Drug

BI 3034701

Placebo

Drug

Placebo

Primary outcomes

Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigatorPart 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

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Fukuoka Mirai Hospital🇯🇵 Fukuoka, Fukuoka, Japan
Boehringer IngelheimContact
SOUSEIKAI Hakata Clinic🇯🇵 Fukuoka, Fukuoka, Japan
Boehringer IngelheimContact
SOUSEIKAI Sumida Hospital🇯🇵 Tokyo, Sumida-ku, Japan
Boehringer IngelheimContact