← Trials/Trial dossier/NCT07076030

CompletedPhase 1

Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function

Lead sponsor

Zealand Pharma

Asset

Petrelintide

Subcutaneous · Amylin analog

Listed sites

1

Recruiting sites

Enrollment

39

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criteria

BMI 21-40HbA1c ≤11%

Primary endpoint

AUCo-inf of petrelintide

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07076030
Org study IDZP8396-24059

Timeline

Milestones

Study start2025-04-15actual
Study first posted2025-07-20actual
Primary completion2025-11-25actual
Study completion2025-11-25actual
Last update posted2026-01-28actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

AUCo-inf of petrelintide

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed plasma concentration

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

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to attain maximum observed plasma concentration

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

Tmax

descriptive

Secondary/protocol endpoint

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

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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)

concentration, descriptive

Secondary/protocol endpoint

Terminal elimination half-life

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

Half-life

descriptive

Secondary/protocol endpoint

Apparent clearance

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

descriptive

Secondary/protocol endpoint

Apparent volume of distribution at terminal phase

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

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.