NCT07693231Active, not recruitingPhase 1
A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Japanese Healthy People and Japanese People With Obesity or Overweight
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)
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 3 Jul 2026
- Start date
- 21 Jul 2026
- Primary completion date
- 22 Dec 2026
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Obesity
- NCT number
- NCT07693231
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 48
- From 21 Jul 2026 to the primary completion date, 22 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Part 1: Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening
Lab values
- 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
Other
- 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
- Further exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fukuoka Mirai Hospital Coordinator of this site? Confirm its status | Fukuoka, Fukuoka | Japan | Unknown status |
| SOUSEIKAI Hakata Clinic Coordinator of this site? Confirm its status | Fukuoka, Fukuoka | Japan | Unknown status |
| SOUSEIKAI Sumida Hospital Coordinator of this site? Confirm its status | Tokyo, Sumida-ku | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.