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Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function
Lead sponsor
Asset
Petrelintide
Subcutaneous · Amylin analog
Listed sites
1
Recruiting sites
—
Enrollment
39
actual
Study population
Healthy volunteers, Renal impairment
Key I/E criteria
•BMI 21-40•HbA1c ≤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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsAUCo-inf of petrelintide
Time frame:From administration (Day 1) to Last visit (Day 43)
AUC₀–∞
concentration, descriptive
Maximum observed plasma concentration
Time frame:From administration (Day 1) to Last visit (Day 43)
Cmax
concentration, descriptive
Time to attain maximum observed plasma concentration
Time frame:From administration (Day 1) to Last visit (Day 43)
Tmax
descriptive
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
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
Terminal elimination half-life
Time frame:From administration (Day 1) to Last visit (Day 43)
Half-life
descriptive
Apparent clearance
Time frame:From administration (Day 1) to Last visit (Day 43)
descriptive
Apparent volume of distribution at terminal phase
Time frame:From administration (Day 1) to Last visit (Day 43)
descriptive
Provenance
Sources
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.