HealthyPhase 1NCT06352437
A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity
A Phase 1 study testing BI 3034701 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 3034701
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jun 2024to 7 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A: healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Part B: healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
- Part A: age of 18 to 55 years (inclusive). Part B: age 18 to 65 years (inclusive).
- Parts A and B: Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Further inclusion criteria apply
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (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 (bpm).
- 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%
Show all 11Show fewer
- 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
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Subcutaneous Doses of BI 3034701 in Healthy Male Volunteers (Part A) and of Multiple Rising Subcutaneous Doses in Otherwise Healthy Male and Female Volunteers With Obesity/Overweight (Part B)
This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy.
The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men (Part A) and people with overweight or obesity (Part B). Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood.
Read more
Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo. In this study, BI 3034701 is given to humans for the first time.
Participants in Part A are in the study up to 10 weeks. During this time, they visit the study site 8 times. Participants in Part B are in the study for about 5 months. They visit the study regularly. At some of the visits, participants in both parts stay at the study site for up to 5 nights. During the study, the doctors collect information on any health problems of the participants.
- Conditions
- Healthy
- Being tested
- BI 3034701, Placebo matching BI 3034701
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3034701Drug
BI 3034701
Placebo matching BI 3034701Drug
Placebo matching BI 3034701
| Study group | Role | What they receive |
|---|---|---|
| Part A: BI 3034701 dose group 1 | Experimental | Not described |
| Part A: BI 3034701 dose group 2 | Experimental | Not described Receives: Drug: BI 3034701 |
| Part A: BI 3034701 dose group 3 | Experimental | Not described Receives: Drug: BI 3034701 |
| Part A: BI 3034701 dose group 4 | Experimental | Not described Receives: Drug: BI 3034701 |
| Part A: BI 3034701 dose group 5 | Experimental | Not described Receives: Drug: BI 3034701 |
| Part A: BI 3034701 dose group 6 | Experimental | Not described Receives: Drug: BI 3034701 |
| Part A: BI 3034701 dose group 7 | Experimental | Not described |
| Part A: BI 3034701 dose group | Experimental | Not described Receives: Drug: BI 3034701 |
| Part A: Placebo | Placebo comparator | Not described Receives: Drug: Placebo matching BI 3034701 |
| Part B: BI 3034701 dose group 1 | Experimental | Not described Receives: Drug: BI 3034701 |
| Part B: BI 3034701 dose group 2 | Experimental | Not described Receives: Drug: BI 3034701 |
| Part B: BI 3034701 dose group 3 | Experimental | Not described Receives: Drug: BI 3034701 |
| Part B: BI 3034701 dose group 4 | Experimental | Not described Receives: Drug: BI 3034701 |
| Part B: Placebo | Placebo comparator | Not described Receives: Drug: Placebo matching BI 3034701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A and Part B: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Measured: up to 48 days for Part A and up to 130 days for Part B.
Secondary outcomes (4)
Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) following a single dose of BI 3034701
Measured: up to 48 days.
Part A: Maximum measured concentration of the analyte in plasma (Cmax) following a single dose of BI 3034701
Measured: up to 48 days.
Part B: Area under the concentration-time curve in plasma over the dosing interval of 0 to 168 hours (AUCtau) following multiple doses of BI 3034701
Measured: up to 130 days.
Part B: Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701
Measured: up to 130 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start10 Jun 2024
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
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
- 125 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
- NCT06352437
- Sponsor's protocol ID
- 1507-0001
- Other IDs
- 2023-508767-79-00, U1111-1302-5933, 2023
- Status last verified
- Nov 2025
- First submitted
- 3 Apr 2024
- Last updated
- 21 Nov 2025
- 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.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single Subcutaneous Doses of BI 3034701 in Healthy Male Volunteers (Part A) and of Multiple Rising Subcutaneous Doses in Otherwise Healthy Male and Female Volunteers With Obesity/Overweight (Part B)
- ClinicalTrials.gov ID
- NCT06352437
- Acronym / sponsor ID
- 1507-0001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 8 Apr 2024 (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.
This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy.
The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men (Part A) and people with overweight or obesity (Part B). Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood.
Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo. In this study, BI 3034701 is given to humans for the first time.
Participants in Part A are in the study up to 10 weeks. During this time, they visit the study site 8 times. Participants in Part B are in the study for about 5 months. They visit the study regularly. At some of the visits, participants in both parts stay at the study site for up to 5 nights. During the study, the doctors collect information on any health problems of the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part A: BI 3034701 dose group 1 | Experimental | – |
| Part A: BI 3034701 dose group 2 | Experimental | Drug: BI 3034701 |
| Part A: BI 3034701 dose group 3 | Experimental | Drug: BI 3034701 |
| Part A: BI 3034701 dose group 4 | Experimental | Drug: BI 3034701 |
| Part A: BI 3034701 dose group 5 | Experimental | Drug: BI 3034701 |
| Part A: BI 3034701 dose group 6 | Experimental | Drug: BI 3034701 |
| Part A: BI 3034701 dose group 7 | Experimental | – |
| Part A: BI 3034701 dose group | Experimental | Drug: BI 3034701 |
| Part A: Placebo | Placebo comparator | Drug: Placebo matching BI 3034701 |
| Part B: BI 3034701 dose group 1 | Experimental | Drug: BI 3034701 |
| Part B: BI 3034701 dose group 2 | Experimental | Drug: BI 3034701 |
| Part B: BI 3034701 dose group 3 | Experimental | Drug: BI 3034701 |
| Part B: BI 3034701 dose group 4 | Experimental | Drug: BI 3034701 |
| Part B: Placebo | Placebo comparator | Drug: Placebo matching BI 3034701 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Part A: healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Part B: healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
- Part A: age of 18 to 55 years (inclusive). Part B: age 18 to 65 years (inclusive).
- Parts A and B: Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Further inclusion criteria apply
Key exclusion criteria (11 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (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 (bpm).
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and, in particular:
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- 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 | Part A: BI 3034701 dose group, Part A: BI 3034701 dose group 2, Part A: BI 3034701 dose group 3, Part A: BI 3034701 dose group 4, Part A: BI 3034701 dose group 5, Part A: BI 3034701 dose group 6, Part B: BI 3034701 dose group 1, Part B: BI 3034701 dose group 2, Part B: BI 3034701 dose group 3, Part B: BI 3034701 dose group 4 |
| Placebo matching BI 3034701Placebo matching BI 3034701 | Drug | Part A: Placebo, Part B: Placebo |
Primary outcome
Part A and Part B: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: up to 48 days for Part A and up to 130 days for Part B.
4 secondary outcomes
Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) following a single dose of BI 3034701
Time frame: up to 48 days.
Part A: Maximum measured concentration of the analyte in plasma (Cmax) following a single dose of BI 3034701
Time frame: up to 48 days.
Part B: Area under the concentration-time curve in plasma over the dosing interval of 0 to 168 hours (AUCtau) following multiple doses of BI 3034701
Time frame: up to 130 days.
Part B: Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701
Time frame: up to 130 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- 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.mystudywindow.com/msw/datatransparency
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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.
1 site 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, run by Boehringer Ingelheim at 1 site in Germany.
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 11 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part A and Part B: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator (time frame: up to 48 days for Part A and up to 130 days for Part B.). 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 21 Nov 2025.