HealthyPhase 1NCT05751226
A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906
A Phase 1 study testing BI 1820237, semaglutide and BI 456906 in people with Healthy and Obesity, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
This study is open to adults between 18 and 55 years of age who are living with overweight or obesity. People with a body mass index (BMI) from 27 to 40 kg/m2 can join the study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- BI 1820237, semaglutide and BI 456906
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteGermany
- Study dates
- 11 Apr 2023to 1 Aug 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- 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 18 to 55 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
- 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the Investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy, bariatric surgery 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: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Titration Schedules of Subcutaneous Doses of BI 1820237 Alone or Together With Either Semaglutide or BI 456906 in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Multiple Dose, Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
This study is open to adults between 18 and 55 years of age who are living with overweight or obesity. People with a body mass index (BMI) from 27 to 40 kg/m2 can join the study.
The main purpose of this study is to find out how a medicine called BI 1820237 is tolerated by people with overweight or obesity when taken alone or in combination with a medicine called semaglutide or with a medicine called BI 456906.
Read more
Participants are divided into different groups. All participants in the study either take different doses of BI 1820237 or placebo. Some of the groups take either semaglutide or BI 456906 in addition.
Each participant has an equal chance of being in each group. All participants receive the study medicines as injections under the skin once a week for almost 5 months. Placebo injections look like BI 1820237 injections, but do not contain any medicine. Semaglutide is medicine that is already used for overweight or obesity. BI 456906 is another medicine that is being developed for the treatment of overweight and obesity. Participants are in the study for about 7 months. During this time, they visit the study site regularly. For some of the visits, the participants remain at the study site for 1 or 2 nights. At the study visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1820237, semaglutide, or BI 456906.
- Being tested
- BI 1820237, semaglutide, Placebo, 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 1820237Drug
BI 1820237
semaglutideDrug
semaglutide
PlaceboDrug
Placebo
BI 456906Drug
BI 456906
| Study group | Role | What they receive |
|---|---|---|
| BI 1820237 treatment group | Experimental | Not described Receives: Drug: BI 1820237 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
| BI 1820237 + semaglutide treatment group | Experimental | Not described Receives: Drug: BI 1820237; Drug: semaglutide |
| placebo + semaglutide group | Active comparator | Not described Receives: Drug: semaglutide; Drug: Placebo |
| BI 1820237 + BI 456906 treatment group | Experimental | Not described Receives: Drug: BI 1820237; Drug: BI 456906 |
| placebo + BI 456906 group | Active comparator | Not described Receives: Drug: Placebo; Drug: BI 456906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of treatment-emergent adverse events
assessed as drug-related by the investigator
Measured: Up to 180 days
Secondary outcomes (2)
Area under the concentration-time curve of BI 1820237 in plasma over the time interval from 0 to 168 hours after administration of BI 1820237 or placebo (AUC0-168)
Measured: Up to 141 days
Maximum measured concentration of BI 1820237 in plasma (Cmax)
Measured: Up to 141 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start11 Apr 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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
- 88 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
- NCT05751226
- Sponsor's protocol ID
- 1458-0002
- Other IDs
- 2022-002733-34
- Status last verified
- Jan 2025
- First submitted
- 21 Feb 2023
- Last updated
- 22 Jan 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Titration Schedules of Subcutaneous Doses of BI 1820237 Alone or Together With Either Semaglutide or BI 456906 in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Multiple Dose, Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT05751226
- Acronym / sponsor ID
- 1458-0002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 2 Mar 2023 (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 adults between 18 and 55 years of age who are living with overweight or obesity. People with a body mass index (BMI) from 27 to 40 kg/m2 can join the study.
The main purpose of this study is to find out how a medicine called BI 1820237 is tolerated by people with overweight or obesity when taken alone or in combination with a medicine called semaglutide or with a medicine called BI 456906.
Participants are divided into different groups. All participants in the study either take different doses of BI 1820237 or placebo. Some of the groups take either semaglutide or BI 456906 in addition.
Each participant has an equal chance of being in each group. All participants receive the study medicines as injections under the skin once a week for almost 5 months. Placebo injections look like BI 1820237 injections, but do not contain any medicine. Semaglutide is medicine that is already used for overweight or obesity. BI 456906 is another medicine that is being developed for the treatment of overweight and obesity. Participants are in the study for about 7 months. During this time, they visit the study site regularly. For some of the visits, the participants remain at the study site for 1 or 2 nights. At the study visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1820237, semaglutide, or BI 456906.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BI 1820237 treatment group | Experimental | Drug: BI 1820237 |
| Placebo group | Placebo comparator | Drug: Placebo |
| BI 1820237 + semaglutide treatment group | Experimental | Drug: BI 1820237, Drug: semaglutide |
| placebo + semaglutide group | Active comparator | Drug: semaglutide, Drug: Placebo |
| BI 1820237 + BI 456906 treatment group | Experimental | Drug: BI 1820237, Drug: BI 456906 |
| placebo + BI 456906 group | Active comparator | Drug: Placebo, Drug: BI 456906 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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 18 to 55 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
- 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 bpm
- Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the Investigator
- 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 1820237BI 1820237 | Drug | BI 1820237 + BI 456906 treatment group, BI 1820237 + semaglutide treatment group, BI 1820237 treatment group |
| semaglutidesemaglutide | Drug | BI 1820237 + semaglutide treatment group, placebo + semaglutide group |
| PlaceboPlacebo | Drug | Placebo group, placebo + BI 456906 group, placebo + semaglutide group |
| BI 456906BI 456906 | Drug | BI 1820237 + BI 456906 treatment group, placebo + BI 456906 group |
Primary outcome
Percentage of treatment-emergent adverse events
Time frame: Up to 180 days
assessed as drug-related by the investigator
2 secondary outcomes
Area under the concentration-time curve of BI 1820237 in plasma over the time interval from 0 to 168 hours after administration of BI 1820237 or placebo (AUC0-168)
Time frame: Up to 141 days
Maximum measured concentration of BI 1820237 in plasma (Cmax)
Time frame: Up to 141 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 22 Jan 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 1820237, semaglutide and BI 456906 in people with Healthy and 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 6 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 22 Jan 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?
Percentage of treatment-emergent adverse events (time frame: Up to 180 days). 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 22 Jan 2025.