New drug candidate BI 3034701 targets obesity in japanese adults
NCT ID NCT07693231
First seen Jul 09, 2026 · Last updated Jul 24, 2026 · Updated 3 times
Summary
This early-stage trial investigates a new drug called BI 3034701 in Japanese adults. Part 1 includes people with obesity or overweight (BMI 27 or higher) to see if the drug is safe and how the body processes it over 16 weeks. Part 2 includes healthy volunteers with a BMI between 23 and 27 to check safety and drug levels over 7 weeks. The study aims to gather initial information on safety, tolerability, and how the drug moves through the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 3034701
- What this could lead to
- If successful, this could point toward a new treatment option for obesity and overweight in Japanese adults.
- What could go wrong
- This is an early phase 1 trial with only 48 participants, so the drug may not prove safe or effective. Side effects are possible and not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fukuoka Mirai Hospital
RECRUITINGFukuoka, Fukuoka, 813-0017, Japan
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SOUSEIKAI Hakata Clinic
RECRUITINGFukuoka, Fukuoka, 812-0025, Japan
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SOUSEIKAI Sumida Hospital
RECRUITINGTokyo, Sumida-ku, 130-0004, Japan
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