臨床研究等提出・公開システム

A Phase I, Single-blinded, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3034701 in Japanese Male and Female Participants With Obesity/Overweight and Otherwise Healthy (Part 1) and Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 3034701 in Japanese Male and Female Healthy Volunteers (Part 2)

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

Takayama Hanae

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Katakabe Tetsuya

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Not Recruiting

July. 08, 2026

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

-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
-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
-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
-Further inclusion criteria apply.

-Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
-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
-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
-Part 1: Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening
-Further exclusion criteria apply.

Both

Healthy, Obesity

BI 3034701, Placebo

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

-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
-Maximum measured concentration of the analyte in plasma (Cmax) following a single dose and multiple doses of BI 3034701
-Change from baseline in body weight at the end of 16 weeks treatment (only evaluated for Part 1)

+81-92-283-7701

June. 25, 2026

Yes

Researchers can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from our clinical studies.

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