OverweightPhase 1NCT06200467
A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity
A Phase 1 study testing BI 456906 and Moxifloxacin in people with Overweight 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 with overweight or obesity. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) has an effect on cardiac safety. When a new medicine is developed, it is important to check whether it affects the heart. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- BI 456906 and Moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 13 Mar 2024to 22 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Otherwise 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 (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 39.9 kg/m2 (inclusive) and body weight > 70 kg
- 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
- Female subjects who meet any of the following criteria for a highly effective contraception from at least 7 days before the first administration of trial medication until 28 days after trial completion:
- Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal). In case of oral contraception a barrier method should be used in addition.
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- Use of progestogen-only hormonal contraception that inhibits ovulation (oral, injectable or implantable). In case of oral contraception a barrier method should be used in addition.
- Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- Sexually abstinent
- A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
- Surgically sterilised (including hysterectomy)
- Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of 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
- 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 glutamyltransferase (GGT) above ULN + 20%
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- Lipase or amylase above ULN + 20%
- Bilirubin above 1.2x ULN (except for cases of Gilbert's Syndrome)
- eGFR < 60 mL/min/1.73 m²
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- History of either chronic or acute pancreatitis
- 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 Double-blind, Randomized, Placebo-controlled, Multiple-dose, Parallel Group With Nested Crossover Design Trial With Moxifloxacin as Positive Control to Evaluate the Effects of Multiple Subcutaneous Doses of BI 456906 in a Titration Scheme on Cardiac Safety Parameters in (Otherwise) Healthy Male and Female Subjects With Overweight/Obesity
This study is open to adults between 18 and 55 years of age with overweight or obesity. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) has an effect on cardiac safety. When a new medicine is developed, it is important to check whether it affects the heart. Moxifloxacin is a medicine that is known to change the heart rhythm. In this study, moxifloxacin is used as a so-called positive control.
Participants are put into 3 groups by chance. There is a different treatment schedule for each of the groups. All participants start with one placebo injection under their skin. The next day, depending on the group, participants take either moxifloxacin or placebo as a tablet. Then, for about 30 weeks, participants receive survodutide or placebo as an injection under their skin once a week. After this, they take again a single dose of moxifloxacin or placebo.
Participants are in the study for up to 9 months. During this time, they visit the study site regularly. For 2 of the visits, participants stay at the study site for 2 nights. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the study staff regularly performs ECG tests. The doctors also regularly check participants' health and take note of any unwanted effects.
- Conditions
- Overweight, Obesity
- Being tested
- BI 456906, Placebo to BI 456906, Moxifloxacin, Placebo to moxifloxacin
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 456906Combination product
Also called survodutide
Solution for injection, pre-filled syringe
Placebo to BI 456906Combination product
Also called BI 456906-placebo
Solution for injection, pre-filled syringe
MoxifloxacinDrug
Film-coated tablet
Placebo to moxifloxacinDrug
Film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm A: R1 then R3 then T then R | Experimental | Arm A: BI 456906-placebo (reference treatment 1 (R1)) then moxifloxacin-placebo (reference treatment 3 (R3)) then BI 456906 (Test Treatment (T)) then moxifloxacin-placebo (R3) Receives: Combination Product: BI 456906; Combination Product: Placebo to BI 456906; Drug: Placebo to moxifloxacin |
| Arm B: R1 then R2 then R1 then R3 | Placebo comparator | Arm B: BI 456906-placebo (R1) then moxifloxacin (Reference Treatment 2 (R2)) then BI 456906-placebo (R1) then moxifloxacin-placebo (R3) Receives: Combination Product: Placebo to BI 456906; Drug: Moxifloxacin; Drug: Placebo to moxifloxacin |
| Arm C: R1 then R3 then R1 then R2 | Placebo comparator | Arm C: BI 456906-placebo (R1) then moxifloxacin-placebo (R3) then BI 456906-placebo (R1) then moxifloxacin (R2) Receives: Combination Product: Placebo to BI 456906; Drug: Moxifloxacin; Drug: Placebo to moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-matched QTcI change from baseline (ΔQTcI) collected at the same time points as the BI 456906 plasma concentrations up to a maximum of 30 weeks after first drug administration of BI 456906 / BI 456906-placebo
QTcI is the QT interval (electrocardiogram interval from the start of the QRS complex (combination of the Q wave, R wave and S wave) to the end of the T wave) individually corrected for heart rate.
Measured: up to 30 weeks.
Secondary outcomes (2)
The QTcI change from baseline (ΔQTcI) collected at the same time points as the moxifloxacin plasma concentrations up to 12 hours after drug administration of a single dose of moxifloxacin or moxifloxacin-placebo
Measured: up to 12 hours.
The time-matched heart rate change from baseline (ΔHR) collected at the same time points as the BI 456906 plasma concentrations up to a maximum of 30 weeks after first drug administration of BI 456906 / BI 456906-placebo
Measured: up to 30 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start13 Mar 2024
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Model description
- Parallel group design trial, with moxifloxacin as positive control in a nested cross-over in healthy male and female subjects with overweight/obesity.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 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
- NCT06200467
- Sponsor's protocol ID
- 1404-0011
- Other IDs
- 2023-506375-10-00, U1111-1295-4369, 2023
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Parallel Group With Nested Crossover Design Trial With Moxifloxacin as Positive Control to Evaluate the Effects of Multiple Subcutaneous Doses of BI 456906 in a Titration Scheme on Cardiac Safety Parameters in (Otherwise) Healthy Male and Female Subjects With Overweight/Obesity
- ClinicalTrials.gov ID
- NCT06200467
- Acronym / sponsor ID
- 1404-0011
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 11 Jan 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 adults between 18 and 55 years of age with overweight or obesity. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) has an effect on cardiac safety. When a new medicine is developed, it is important to check whether it affects the heart. Moxifloxacin is a medicine that is known to change the heart rhythm. In this study, moxifloxacin is used as a so-called positive control.
Participants are put into 3 groups by chance. There is a different treatment schedule for each of the groups. All participants start with one placebo injection under their skin. The next day, depending on the group, participants take either moxifloxacin or placebo as a tablet. Then, for about 30 weeks, participants receive survodutide or placebo as an injection under their skin once a week. After this, they take again a single dose of moxifloxacin or placebo.
Participants are in the study for up to 9 months. During this time, they visit the study site regularly. For 2 of the visits, participants stay at the study site for 2 nights. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the study staff regularly performs ECG tests. The doctors also regularly check participants' health and take note of any unwanted effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel group design trial, with moxifloxacin as positive control in a nested cross-over in healthy male and female subjects with overweight/obesity.
| Arm | Type | Receives |
|---|---|---|
| Arm A: R1 then R3 then T then R | Experimental | Combination Product: BI 456906, Combination Product: Placebo to BI 456906, Drug: Placebo to moxifloxacinArm A: BI 456906-placebo (reference treatment 1 (R1)) then moxifloxacin-placebo (reference treatment 3 (R3)) then BI 456906 (Test Treatment (T)) then moxifloxacin-placebo (R3) |
| Arm B: R1 then R2 then R1 then R3 | Placebo comparator | Combination Product: Placebo to BI 456906, Drug: Moxifloxacin, Drug: Placebo to moxifloxacinArm B: BI 456906-placebo (R1) then moxifloxacin (Reference Treatment 2 (R2)) then BI 456906-placebo (R1) then moxifloxacin-placebo (R3) |
| Arm C: R1 then R3 then R1 then R2 | Placebo comparator | Combination Product: Placebo to BI 456906, Drug: Moxifloxacin, Drug: Placebo to moxifloxacinArm C: BI 456906-placebo (R1) then moxifloxacin-placebo (R3) then BI 456906-placebo (R1) then moxifloxacin (R2) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Otherwise 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 (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 39.9 kg/m2 (inclusive) and body weight > 70 kg
- 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
- Female subjects who meet any of the following criteria for a highly effective contraception from at least 7 days before the first administration of trial medication until 28 days after trial completion:
Key exclusion criteria (14 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
- 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 456906Also: survodutideSolution for injection, pre-filled syringe | Combination product | Arm A: R1 then R3 then T then R |
| Placebo to BI 456906Also: BI 456906-placeboSolution for injection, pre-filled syringe | Combination product | Arm A: R1 then R3 then T then R, Arm B: R1 then R2 then R1 then R3, Arm C: R1 then R3 then R1 then R2 |
| MoxifloxacinFilm-coated tablet | Drug | Arm B: R1 then R2 then R1 then R3, Arm C: R1 then R3 then R1 then R2 |
| Placebo to moxifloxacinFilm-coated tablet | Drug | Arm A: R1 then R3 then T then R, Arm B: R1 then R2 then R1 then R3, Arm C: R1 then R3 then R1 then R2 |
Primary outcome
Time-matched QTcI change from baseline (ΔQTcI) collected at the same time points as the BI 456906 plasma concentrations up to a maximum of 30 weeks after first drug administration of BI 456906 / BI 456906-placebo
Time frame: up to 30 weeks.
QTcI is the QT interval (electrocardiogram interval from the start of the QRS complex (combination of the Q wave, R wave and S wave) to the end of the T wave) individually corrected for heart rate.
2 secondary outcomes
The QTcI change from baseline (ΔQTcI) collected at the same time points as the moxifloxacin plasma concentrations up to 12 hours after drug administration of a single dose of moxifloxacin or moxifloxacin-placebo
Time frame: up to 12 hours.
The time-matched heart rate change from baseline (ΔHR) collected at the same time points as the BI 456906 plasma concentrations up to a maximum of 30 weeks after first drug administration of BI 456906 / BI 456906-placebo
Time frame: up to 30 weeks.
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 13 Mar 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.
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 Moxifloxacin in people with Overweight 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 12 inclusion and 14 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 13 Mar 2026. 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?
Time-matched QTcI change from baseline (ΔQTcI) collected at the same time points as the BI 456906 plasma concentrations up to a maximum of 30 weeks after first drug administration of BI 456906 / BI 456906-placebo (time frame: up to 30 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 13 Mar 2026.