Kidney function may affect new Weight-Loss drug
NCT ID NCT07076030
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new weight-management drug called petrelintide in 39 people with normal or impaired kidney function. Researchers wanted to see if kidney problems change how the drug behaves in the body. The goal is to guide safe dosing for people with kidney issues who might use this drug for weight loss.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- petrelintide (ZP8396)
- What this could lead to
- If successful, this study could help doctors understand how to dose petrelintide safely in people with kidney problems.
- What could go wrong
- This is a very early Phase 1 study with only 39 people, so results may not apply to everyone. It only looks at drug levels in the blood, not weight loss or long-term safety.
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
-
39 people
The number who actually took part.
- Started
-
Apr 2025
- Finished
-
Nov 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 65 years
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Age: 18 to 65 years (both inclusive) at screening. 2. BMI (Body Mass Index): 21.0 to 40.0 kg/m2, inclusive, at screening. 3. Sex: Male and female participants. 4. Participants with mild, moderate, or severe renal impairment and participants with normal renal function. 5. For participants with renal impairment: stable renal impairment for 3 months prior to screening. 6. For participants with Type 2 diabetes mellitus and renal impairment: 1. HbA1c (hemoglobin A1c) ≤11% at screening. 2. On a stable diet and exercise regimen or stable metformin and/or SGLT2i (Sodium-Glucose Cotransporter 2 inhibitors) treatment for at least 3 months prior to screening. Exclusion Criteria: 1. Exposure to amylin analogs, including petrelintide (ZP8396) within the last 3 months. 2. Clinically significant acute illness within 4 weeks prior to Day 1, as judged by the Investigator to potentially interfere with the study conduct and/or results. 3. Impaired liver function, defined as alanine aminotransferase (ALT) \>1.2 times upper normal limit, or bilirubin \>1.2 times upper normal limit, measured at screening. 4. Presence or history of acute or chronic pancreatitis. 5. Known clinically significant gastric emptying abnormality (for example, severe gastroparesis, gastric outlet obstruction, gastric bypass operations, or sleeve gastrectomies) or chronic treatment that affects gastrointestinal motility. 6. Any disorder, unwillingness, or inability, not covered by any of the other exclusions criteria, which in the Investigator´s opinion, might jeopardize the participant´s safety or compliance with the protocol. 7. Participants with Type 1 diabetes mellitus as declared by the participant. 8. A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). 9. Presence or history of clinically significant arrhythmias or clinically significant conduction disorders. 10. A marked baseline prolongation of QT/QTc (e.g. repeated demonstration of a QTc interval \>450 ms. 11. Smoking of more than 10 cigarettes (or equivalent nicotine consumption) per day. Tobacco that contains menthol must not be consumed within 7 days prior to study drug administration. 12. Presence or history of following cardiovascular diseases: 1. Decompensated heart failure (New York Heart Association (NYHA) class III and IV). 2. Unstable angina pectoris. 3. Myocardial infarction within the last 12 months.
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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
-
Charité Research Organisation GmbH
Berlin, 10117, Germany
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Other studies related to the condition(s) this trial covers.
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