A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity

Sponsor
Boehringer Ingelheim
Study ID
NCT06200467
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BI 456906 — COMBINATION_PRODUCT
    Solution for injection, pre-filled syringe
  • Placebo to BI 456906 — COMBINATION_PRODUCT
    Solution for injection, pre-filled syringe
  • Moxifloxacin — DRUG
    Film-coated tablet
  • Placebo to moxifloxacin — DRUG
    Film-coated tablet

Study Details

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.

Key Dates

Start date
Mar 13, 2024
Status verified
Mar 2026
Primary completion
Oct 22, 2025
Completion
Oct 22, 2025

Study Design

Enrollment
110 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 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. ]

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