NCT06200467

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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. 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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BI 456906	Solution for injection, pre-filled syringe
COMBINATION_PRODUCT	Placebo to BI 456906	Solution for injection, pre-filled syringe
DRUG	Moxifloxacin	Film-coated tablet
DRUG	Placebo to moxifloxacin	Film-coated tablet

Timeline

• Start date: 2024-03-13
• Primary completion: 2025-10-22
• Completion: 2025-10-22
• First posted: 2024-01-11
• Last updated: 2026-03-13

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study