Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function

NCT07076030 | Completed Phase 1 FDA Drug

• 1 other identifier: ZP8396-24059
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (1)

• AUCo-inf of petrelintide

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

  From administration (Day 1) to Last visit (Day 43)

Secondary Outcomes (7)

• Maximum observed plasma concentration

  From administration (Day 1) to Last visit (Day 43)

• Time to attain maximum observed plasma concentration

  From administration (Day 1) to Last visit (Day 43)

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

  From administration (Day 1) to Last visit (Day 43)

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

  From administration (Day 1) to Last visit (Day 43)

• Terminal elimination half-life

  From administration (Day 1) to Last visit (Day 43)

Study Arms (4)

Group 1 Normal Renal Function

EXPERIMENTAL

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

Drug: Petrelintide

Group 2 Mild Renal Impairment

EXPERIMENTAL

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

Drug: Petrelintide

Group 3 Moderate Renal Impairment

EXPERIMENTAL

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

Drug: Petrelintide

Group 4 Severe Renal Impairment

EXPERIMENTAL

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

Drug: Petrelintide

Interventions

Petrelintide DRUG

Solution administered with a syringe

Also known as: ZP8396

Group 1 Normal Renal Function; Group 2 Mild Renal Impairment; Group 3 Moderate Renal Impairment; Group 4 Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65 years (both inclusive) at screening.
• BMI (Body Mass Index): 21.0 to 40.0 kg/m2, inclusive, at screening.
• Sex: Male and female participants.
• Participants with mild, moderate, or severe renal impairment and participants with normal renal function.
• For participants with renal impairment: stable renal impairment for 3 months prior to screening.
• For participants with Type 2 diabetes mellitus and renal impairment:
• HbA1c (hemoglobin A1c) ≤11% at screening.
• 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.

You may not qualify if:

• Exposure to amylin analogs, including petrelintide (ZP8396) within the last 3 months.
• 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.
• 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.
• Presence or history of acute or chronic pancreatitis.
• 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.
• Participants with Type 1 diabetes mellitus as declared by the participant.
• A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• Presence or history of clinically significant arrhythmias or clinically significant conduction disorders.
• A marked baseline prolongation of QT/QTc (e.g. repeated demonstration of a QTc interval \>450 ms.
• 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.
• Presence or history of following cardiovascular diseases:
• Decompensated heart failure (New York Heart Association (NYHA) class III and IV).
• Unstable angina pectoris.
• Myocardial infarction within the last 12 months.

Sponsors & Collaborators

• Zealand Pharma: lead
• ICON plc: collaborator

Study Sites (1)

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Victoria Kegel-Hübner, Dr.med.

  Charité Research Organisation GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: April 15, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)