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

Sponsor
Boehringer Ingelheim
Study ID
NCT06352411
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • BI 456906 — COMBINATION_PRODUCT
    Solution for injection, pre-filled syringe

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
Mar 2026
Primary completion
Sep 16, 2025
Completion
Sep 16, 2025

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Participants with normal renal function
  • Experimental: Group 2: Participants with mild renal impairment
  • Experimental: Group 3: Participants with moderate renal impairment
  • Experimental: Group 4: Participants with severe renal impairment

Primary Outcome Measure

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) [ Time Frame: up to Day 29 ]

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