Current partner codePEPTIDESDE
NCT07076030·Phase 1·INTERVENTIONAL

Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function

Status

Completed

Phase

Phase 1

Enrollment

39

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

This is a Phase 1, open-label, single-center, single dose, parallel-group, non-randomized study to evaluate the pharmacokinetics (PK), safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe renal impairment, and participants with normal renal function. Allocation of participants to the renal function groups will be based on the estimated glomerular filtration rate (eGFR). Each participant will receive a single subcutaneous dose of petrelintide on Day 1. Up to 24 participants with normal renal function and 24 participants with renal impairment (8 participants each in the following groups: mild, moderate, or severe renal impairment) will participate in this study.

Interventions

Treatment arms and agents.

DRUG

Petrelintide

Solution administered with a syringe

Timeline

From registration to results.

  1. First posted

    Jul 20, 2025

  2. Study start

    Apr 15, 2025

  3. Primary completion

    Nov 25, 2025

  4. Study completion

    Nov 25, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jan 28, 2026

Outcomes

What the study measures.

Primary outcomes

AUCo-inf of petrelintide

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

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

Secondary outcomes

Maximum observed plasma concentration

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

Time to attain maximum observed plasma concentration

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

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

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

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)

Terminal elimination half-life

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

Apparent clearance

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

Apparent volume of distribution at terminal phase

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
Yes

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.

Study locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Charité Research Organisation GmbH

Berlin, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Petrelintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.