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NCT Number: NCT07693231

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fukuoka Mirai Hospital, Fukuoka, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Parts 1 and 2: Age of 18 to 64 years (inclusive)
  • Further inclusion criteria apply.

Exclusion criteria

  • 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.

Treatment and study plan

BI 3034701

Drug

BI 3034701

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: 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 outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 9, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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