ObesityPhase 1NCT06352424
A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity
A Phase 1 study testing BI 456906 and BI 1820237 in people with Obesity, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- BI 456906 and BI 1820237
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 30 Apr 2024to 24 Feb 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects with obesity/overweight (otherwise healthy) 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
- Age of 40 to 60 years (inclusive)
- Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive). Overweight/obesity should be due to excess adipose tissue, as judged by the Investigator
- Body weight greater than or equal to 75 kg
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male trial participants without need for contraception
Show all 14Show fewer
- Female trial participants, only if any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 2 months after last administration of trial medication are met:
- Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (intravaginal or transdermal)
- Bilateral tubal occlusion
- A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm according to verbal confirmation of female participant) and provided that partner is the sole sexual partner of the trial participant
- Abstention from male-female sex. This is defined as being in line with the preferred and usual lifestyle of the patient. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods; declaration of abstinence for the duration of exposure to study drug, and withdrawal are not acceptable.
- Or female subject meets any of the following criteria:
- Permanent sterilisation by hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy
- Woman is postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
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
- 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 bpm and assessed as clinically relevant by the investigator
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Randomized, Placebo-controlled Phase I Study on the Effects of a Subcutaneous Dose of BI 1820237 and BI 456906, and Combination Thereof on Functional MRI Measurements in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Single-blind, Cross-over Design)
The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity.
- Conditions
- Obesity
- Being tested
- BI 456906, BI 1820237, Placebo for BI 1820237, Placebo for BI 456906
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 456906Drug
BI 456906
BI 1820237Drug
BI 1820237
Placebo for BI 1820237Drug
Placebo for BI 1820237
Placebo for BI 456906Drug
Placebo for BI 456906
| Study group | Role | What they receive |
|---|---|---|
| A-B-C-D | Experimental | * A: Treatment Test 1 (T1): BI 1820237 + Placebo for BI 456906
* B: Treatment Test 2 (T2): BI 456906 + Placebo for BI 1820237
* C: Treatment Test 3 (T3): BI 1820237 + BI 456906
* D: Treatment Reference (R1, R2): Placebo for BI 1820237 + Placebo for BI 456906 Receives: Drug: BI 456906; Drug: BI 1820237; Drug: Placebo for BI 1820237; Drug: Placebo for BI 456906 |
| B-D-A-C | Experimental | Not described Receives: Drug: BI 456906; Drug: BI 1820237; Drug: Placebo for BI 1820237; Drug: Placebo for BI 456906 |
| C-A-D-B | Experimental | Not described Receives: Drug: BI 456906; Drug: BI 1820237; Drug: Placebo for BI 1820237; Drug: Placebo for BI 456906 |
| D-C-B-A | Experimental | Not described Receives: Drug: BI 456906; Drug: BI 1820237; Drug: Placebo for BI 1820237; Drug: Placebo for BI 456906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo
- in the fasted state in response to food visual stimuli and nutrient-specific food preference
- assessed by task based functional magnetic resonance imaging (fMRI) in the whole brain
Measured: 32 days plus up to 8 weeks wash-out for each sequence, up to 51 weeks
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 start30 Apr 2024
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 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
- NCT06352424
- Sponsor's protocol ID
- 1458-0006
- Other IDs
- 2023-506233-30-01, U1111-1293-4672, 2023
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2024
- Last updated
- 12 Mar 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomized, Placebo-controlled Phase I Study on the Effects of a Subcutaneous Dose of BI 1820237 and BI 456906, and Combination Thereof on Functional MRI Measurements in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Single-blind, Cross-over Design)
- ClinicalTrials.gov ID
- NCT06352424
- Acronym / sponsor ID
- 1458-0006
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 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.
The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A-B-C-D | Experimental | Drug: BI 456906, Drug: BI 1820237, Drug: Placebo for BI 1820237, Drug: Placebo for BI 456906* A: Treatment Test 1 (T1): BI 1820237 + Placebo for BI 456906 * B: Treatment Test 2 (T2): BI 456906 + Placebo for BI 1820237 * C: Treatment Test 3 (T3): BI 1820237 + BI 456906 * D: Treatment Reference (R1, R2): Placebo for BI 1820237 + Placebo for BI 456906 |
| B-D-A-C | Experimental | Drug: BI 456906, Drug: BI 1820237, Drug: Placebo for BI 1820237, Drug: Placebo for BI 456906 |
| C-A-D-B | Experimental | Drug: BI 456906, Drug: BI 1820237, Drug: Placebo for BI 1820237, Drug: Placebo for BI 456906 |
| D-C-B-A | Experimental | Drug: BI 456906, Drug: BI 1820237, Drug: Placebo for BI 1820237, Drug: Placebo for BI 456906 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or female subjects with obesity/overweight (otherwise healthy) 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
- Age of 40 to 60 years (inclusive)
- Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive). Overweight/obesity should be due to excess adipose tissue, as judged by the Investigator
- Body weight greater than or equal to 75 kg
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- 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 bpm and assessed as clinically relevant by the investigator
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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 456906BI 456906 | Drug | A-B-C-D, B-D-A-C, C-A-D-B, D-C-B-A |
| BI 1820237BI 1820237 | Drug | A-B-C-D, B-D-A-C, C-A-D-B, D-C-B-A |
| Placebo for BI 1820237Placebo for BI 1820237 | Drug | A-B-C-D, B-D-A-C, C-A-D-B, D-C-B-A |
| Placebo for BI 456906Placebo for BI 456906 | Drug | A-B-C-D, B-D-A-C, C-A-D-B, D-C-B-A |
Primary outcome
Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo
Time frame: 32 days plus up to 8 weeks wash-out for each sequence, up to 51 weeks
* in the fasted state in response to food visual stimuli and nutrient-specific food preference * assessed by task based functional magnetic resonance imaging (fMRI) in the whole brain
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 12 Mar 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
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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.
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 456906 and BI 1820237 in people with Obesity, 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 14 inclusion and 8 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 12 Mar 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. 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?
Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo (time frame: 32 days plus up to 8 weeks wash-out for each sequence, up to 51 weeks). 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 12 Mar 2025.