Trial · Interventional
CompletedPhase 1Registry dataA Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 110 participants (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
Germany
- Start
- 13 Mar 2024
- Primary completion
- 22 Oct 2025
- Completion
- 22 Oct 2025
- First posted
- 11 Jan 2024
- Last update posted
- 13 Mar 2026
- Conditions
- Overweight · Obesity
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity
NCT0620046713 Mar 2024 to 22 Oct 2025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- BI 456906Combination product
- Placebo to BI 456906Combination product
- MoxifloxacinDrug
- Placebo to moxifloxacinDrug
Arms3
Experimental
Arm A: R1 then R3 then T then R
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)
Placebo comparator
Arm B: R1 then R2 then R1 then R3
Arm B: BI 456906-placebo (R1) then moxifloxacin (Reference Treatment 2 (R2)) then BI 456906-placebo (R1) then moxifloxacin-placebo (R3)
Placebo comparator
Arm C: R1 then R3 then R1 then R2
Arm C: BI 456906-placebo (R1) then moxifloxacin-placebo (R3) then BI 456906-placebo (R1) then moxifloxacin (R2)
Primary outcomes1
Outcomes the sponsor listed as primary.
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.
Registry description
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.
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
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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