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

Phase 1

Recruiting

• Conditions: Renal Impairment; Healthy
• Interventions: Drug: BI 456906

• Registration Number: NCT06352411
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-08
• Study Start: 2024-05-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-04-29
• Study Completion: 2025-04-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Participants with mild renal impairment	BI 456906	-
Group 3: Participants with moderate renal impairment	BI 456906	-
Group 1: Participants with normal renal function	BI 456906	-
Group 4: Participants with severe renal impairment	BI 456906	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	up to Day 29
Maximum measured concentration of BI 456906 in plasma (Cmax)	up to Day 29

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to Day 29
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator	up to 36 days

Trial Locations

Locations (2)

CRS Clinical Research Services Mannheim GmbH; 🇩🇪 Mannheim, Germany

CRS Clinical Research Services Kiel GmbH; 🇩🇪 Kiel, Germany