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Trial · Interventional

CompletedPhase 1Registry data

Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function

Overview

Status
Completed
Phase
Phase 1
Enrollment
39 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Not randomized · Double masking
Countries
1 country

Germany

Start
15 Apr 2025
Primary completion
25 Nov 2025
Completion
25 Nov 2025
First posted
20 Jul 2025
Last update posted
28 Jan 2026
Conditions
Renal Impairment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026
  1. Ph 1

    Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function

    NCT07076030

    15 Apr 2025 to 25 Nov 2025

Registry summary

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

This clinical research study is testing the study compound petrelintide that is being developed for the weight management in people with obesity or overweight with comorbidities or related diseases. The aim of this clinical research study is to investigate whether the effects of petrelintide will be different in people with normal kidney function compared to people with impaired kidney function.

Interventions

  • PetrelintideDrug

Arms4

  • Experimental

    Group 1 Normal Renal Function

    Each participant will receive a single subcutaneous dose of petrelintide on Day 1.

  • Experimental

    Group 2 Mild Renal Impairment

    Each participant will receive a single subcutaneous dose of petrelintide on Day 1.

  • Experimental

    Group 3 Moderate Renal Impairment

    Each participant will receive a single subcutaneous dose of petrelintide on Day 1.

  • Experimental

    Group 4 Severe Renal Impairment

    Each participant will receive a single subcutaneous dose of petrelintide on Day 1.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. AUCo-inf of petrelintide

    Time frame · From administration (Day 1) to Last visit (Day 43)

    Registry description

    AUCo-inf: Area Under the Curve from time 0 to infinity

Secondary outcomes(7)
  1. Maximum observed plasma concentration

    Time frame · From administration (Day 1) to Last visit (Day 43)

  2. Time to attain maximum observed plasma concentration

    Time frame · From administration (Day 1) to Last visit (Day 43)

  3. Area under the plasma concentration-time curve from time 0 to infinity

    Time frame · From administration (Day 1) to Last visit (Day 43)

  4. Area under the concentration versus time curve from time zero to last measurable concentration

    Time frame · From administration (Day 1) to Last visit (Day 43)

  5. Terminal elimination half-life

    Time frame · From administration (Day 1) to Last visit (Day 43)

  6. Apparent clearance

    Time frame · From administration (Day 1) to Last visit (Day 43)

  7. Apparent volume of distribution at terminal phase

    Time frame · From administration (Day 1) to Last visit (Day 43)

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 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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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