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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT06352411 (opens ClinicalTrials.gov in a new tab)Other id1404-0009Other id2023-508557-13-00Other idU1111-1298-3135Other id2023

Overview

Status
Completed
Phase
Phase 1
Enrollment
42 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Germany

Start
15 May 2024
Primary completion
16 Sept 2025
Completion
16 Sept 2025
First posted
8 Apr 2024
Last update posted
13 Mar 2026
Conditions
Healthy · Renal Impairment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 1

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

    NCT06352411

    15 May 2024 to 16 Sept 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • BI 456906Combination product

Arms4

  • 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 outcomes2

Outcomes the sponsor listed as primary.

  1. 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

  2. Maximum measured concentration of BI 456906 in plasma (Cmax)

    Time frame · up to Day 29

Secondary outcomes(2)
  1. Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame · up to Day 29

  2. Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

    Time frame · up to 36 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria applicable to all participants Participants will only be included in the trial if they meet the following criteria: * Male or female participants with age 18 to 80 years, inclusive at the screening visit. * Body mass index (BMI) of 20.0-40.0 kg/m\^2 (inclusive). * Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use -good clinical practice (ICH-GCP) and local legislation prior to admission to the trial. * Male participants are not required to use contraception. Further criteria apply. Inclusion criteria applying only to participants with impaired renal function: * Renal impairment based on assessment of estimated glomerular filtration rate (eGFR) at screening (severe renal impairment: 10.0-29.9 mL/min, moderate renal impairment: 30.0 - 59.9 mL/min (with at least 4 participants with a GFR between 30.0 and 45.0 mL/min), mild renal impairment: 60.0 - 89.9 mL/min) * Chronic renal impairment \> 12 months (documented renal impairment indicated by reduced eGFR for more than 12 months until screening) * Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening, with the exception of findings that in the opinion of the investigator are consistent with the participant's renal impairment. * Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor. Further criteria apply. Exclusion criteria applying to all participants * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Diseases of the central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder) * History of relevant orthostatic hypotension, fainting spells, or blackouts * Relevant chronic or acute infections Further criteria apply. Exclusion criteria applying only to participants with renal impairment * A marked prolongation of ECG interval from the start of the QRS complex (measured from the beginning of the Q wave to the end of the S wave) to the end of the T wave (QT)/QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF) or Bazett (QTcB)(QTc) interval (such as QTc intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant ECG finding at screening * Acute renal failure or active nephritis * Nephrotic syndrome * Impaired hepatic function, including relevant increases in liver enzymes indicating liver disease Further criteria apply.

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