Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Kidney function may affect new Weight-Loss drug

NCT ID NCT07076030

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Renal impairment are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.