Kidney health may change how obesity drug works in body
NCT ID NCT06352411
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how a single injection of BI 456906, a drug being developed for obesity and liver disease, behaves in the blood of people with different levels of kidney function. Researchers will compare drug levels in 42 adults with normal kidneys to those with mild, moderate, or severe kidney problems. The goal is to see if kidney impairment changes how much drug gets into the bloodstream, which could guide future dosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 456906 (survodutide)
- What this could lead to
- If successful, this study could help doctors understand how to dose BI 456906 safely for people with kidney problems.
- What could go wrong
- This is an early-phase study with only 42 participants, so results may not apply to everyone. It focuses on drug levels, not on treating disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
42 people
The number who actually took part.
- Started
-
May 2024
- Finished
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Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CRS Clinical Research Services Kiel GmbH
Kiel, 24105, Germany
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CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167, Germany
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