NCT06352411

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

Pharmacokinetics, Safety, and Tolerability of BI 456906 Following Subcutaneous Injection in Male and Female Participants With Mild, Moderate and Severe Renal Impairment in Comparison to Participants With Normal Renal Function (Mono-centric, Open-label Study With Parallel Matched-pair Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems. BI 456906 is being developed to treat people with obesity and liver problems. People living with these conditions often also have kidney problems. Therefore, it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood. Study participants receive a single dose of BI 456906 as an injection under the skin. Participants are divided into 4 groups based on how well their kidneys work: 1 group without kidney problems, and 3 groups with mild, moderate, and severe kidney problems. Each participant without kidney problems is matched with participants from the other groups based on factors such as age, gender, race, and body mass index (BMI) to ensure accurate comparisons. Participants are in the study for about 2 months. They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The participants also answer questions about their well-being. The doctors regularly check participants' health and take note of any unwanted effects.

Conditions

• Healthy
• Renal Impairment

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BI 456906	Solution for injection, pre-filled syringe

Timeline

• Start date: 2024-05-15
• Primary completion: 2025-09-16
• Completion: 2025-09-16
• First posted: 2024-04-08
• Last updated: 2026-03-13

Locations

2 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study