HealthyPhase 1NCT07693231
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 1 study testing BI 3034701 in people with Healthy and Obesity, run by Boehringer Ingelheim at 3 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- What is being tested?
- BI 3034701
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesJapan
- Study dates
- 21 Jul 2026to 5 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
SOUSEIKAI Hakata Clinic
Fukuoka, Fukuoka, 812-0025
Fukuoka Mirai Hospital
Fukuoka, Fukuoka, 813-0017
SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, 130-0004
About this study
Official 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)
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.
- Being tested
- BI 3034701, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3034701Drug
BI 3034701
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BI 3034701 | Experimental | Part 1: multiple rising doses in participants with BMI
≥27.0 kg/m² or more
Part 2: multiple rising doses in participants with BMI ≥23.0 to <27.0 kg/m² Receives: Drug: BI 3034701 |
| Placebo | Placebo comparator | Part 1: multiple rising doses in participants with BMI
≥27.0 kg/m² or more
Part 2: multiple rising doses in participants with BMI ≥23.0 to <27.0 kg/m² Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Expressed as the percentage of trial participants treated with investigational drug who experience such an event
Measured: Part 1: up to Week 19, Part 2: up to Week 10
Secondary outcomes (3)
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
Measured: Part 1: up to Week 17, Part 2: up to Week 8
Maximum measured concentration of the analyte in plasma (Cmax) following a single dose and multiple doses of BI 3034701
Measured: Part 1: up to Week 19, Part 2: up to Week 10
Change from baseline in body weight at the end of 16 weeks treatment (only evaluated for Part 1)
Measured: Part 1: at Baseline and at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start21 Jul 2026
- Primary completion22 Dec 2026 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693231
- Sponsor's protocol ID
- 1507-0004
- Other IDs
- U1111-1334-2043
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07693231
- Acronym / sponsor ID
- 1507-0004
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 3034701 | Experimental | Drug: BI 3034701Part 1: multiple rising doses in participants with BMI ≥27.0 kg/m² or more Part 2: multiple rising doses in participants with BMI ≥23.0 to <27.0 kg/m² |
| Placebo | Placebo comparator | Drug: PlaceboPart 1: multiple rising doses in participants with BMI ≥27.0 kg/m² or more Part 2: multiple rising doses in participants with BMI ≥23.0 to <27.0 kg/m² |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 3034701BI 3034701 | Drug | BI 3034701 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 3034701 in people with Healthy and Obesity, run by Boehringer Ingelheim at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.