ObesityPhase 1NCT03591718
A Study to Test Different Doses of BI 456906 in Patients With Obesity
A Phase 1 study testing BI 456906 in people with Obesity, run by Boehringer Ingelheim at 2 sites in Germany.
Trial summary
Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- BI 456906
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 2 sitesGermany
- Study dates
- 26 Jul 2018to 30 Apr 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 18 years and < 70 years of age at screening
- Body Mass Index (BMI) ≥ 27 kg/m2 and <40 kg/m2 at screening
- A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening
- HbA1c <6.5%
- Further inclusion criteria apply
Who cannot join
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Supine blood pressure (BP) ≥160/100 mmHg at screening
- Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Further exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Profil Mainz GmbH & Co. KG
Mainz, 55116
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460
About this study
Official title: A Phase I, Blinded Within Dose Groups, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Titration Schemes of BI 456906 in Patients With Obesity and Overweight.
Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.
- Conditions
- Obesity
- Being tested
- BI 456906, 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 456906Drug
Solution for injection
PlaceboDrug
solution for injection
| Study group | Role | What they receive |
|---|---|---|
| BI 456906 | Experimental | Not described Receives: Drug: BI 456906 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme
Measured: Up to 132 days
Secondary outcomes (2)
AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)
Measured: Up to 168 hours
Cmax (maximum measured concentration of the analyte in plasma) after first dose
Measured: Up to 132 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start26 Jul 2018
- Primary completion20 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 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
- NCT03591718
- Sponsor's protocol ID
- 1404-0003
- Other IDs
- 2018-000250-22, 2018
- Status last verified
- Mar 2021
- First submitted
- 4 Jul 2018
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1.find information in order to request access to clinical study data, for listed studies. 2.request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.
Publications
Jungnik A, Arrubla Martinez J, Plum-Morschel L, Kapitza C, Lamers D, Thamer C, Scholch C, Desch M, Hennige AM. Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906. Diabetes Obes Metab. 2023 Apr;25(4):1011-1023. doi: 10.1111/dom.14948. Epub 2023 Jan 30.
PubMed 36527386
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Blinded Within Dose Groups, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Titration Schemes of BI 456906 in Patients With Obesity and Overweight.
- ClinicalTrials.gov ID
- NCT03591718
- Acronym / sponsor ID
- 1404-0003
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 19 Jul 2018 (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.
Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 456906 | Experimental | Drug: BI 456906 |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients ≥ 18 years and < 70 years of age at screening
- Body Mass Index (BMI) ≥ 27 kg/m2 and <40 kg/m2 at screening
- A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening
- HbA1c <6.5%
- Further inclusion criteria apply
Key exclusion criteria (5 listed)
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Supine blood pressure (BP) ≥160/100 mmHg at screening
- Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- 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 456906Solution for injection | Drug | BI 456906 |
| Placebosolution for injection | Drug | Placebo |
Primary outcome
Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme
Time frame: Up to 132 days
2 secondary outcomes
AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)
Time frame: Up to 168 hours
Cmax (maximum measured concentration of the analyte in plasma) after first dose
Time frame: Up to 132 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 Mar 2021.
- Derived from this study: PubMed 36527386Jungnik A, Arrubla Martinez J, Plum-Morschel L, Kapitza C, Lamers D, Thamer C, Scholch C, Desch M, Hennige AM. Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906. Diabetes Obes Metab. 2023 Apr;25(4):1011-1023. doi: 10.1111/dom.14948. Epub 2023 Jan 30.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1.find information in order to request access to clinical study data, for listed studies. 2.request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.
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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.
2 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 456906 in people with Obesity, run by Boehringer Ingelheim at 2 sites 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 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: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme (time frame: Up to 132 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03591718, which also lists 1 linked publication.
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 Mar 2021.