Renal ImpairmentPhase 1NCT07076030
Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function
A Phase 1 study testing Petrelintide in people with Renal Impairment, run by Zealand Pharma at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Petrelintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2025to 25 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Renal Impairment
- Being tested
- Petrelintide
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PetrelintideDrug
Also called ZP8396
Solution administered with a syringe
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Normal Renal Function | Experimental | Each participant will receive a single subcutaneous dose of petrelintide on Day 1. Receives: Drug: Petrelintide |
| Group 2 Mild Renal Impairment | Experimental | Each participant will receive a single subcutaneous dose of petrelintide on Day 1. Receives: Drug: Petrelintide |
| Group 3 Moderate Renal Impairment | Experimental | Each participant will receive a single subcutaneous dose of petrelintide on Day 1. Receives: Drug: Petrelintide |
| Group 4 Severe Renal Impairment | Experimental | Each participant will receive a single subcutaneous dose of petrelintide on Day 1. Receives: Drug: Petrelintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCo-inf of petrelintide
AUCo-inf: Area Under the Curve from time 0 to infinity
Measured: From administration (Day 1) to Last visit (Day 43)
Secondary outcomes (7)
Maximum observed plasma concentration
Measured: From administration (Day 1) to Last visit (Day 43)
Time to attain maximum observed plasma concentration
Measured: From administration (Day 1) to Last visit (Day 43)
Area under the plasma concentration-time curve from time 0 to infinity
Measured: From administration (Day 1) to Last visit (Day 43)
Area under the concentration versus time curve from time zero to last measurable concentration
Measured: From administration (Day 1) to Last visit (Day 43)
Terminal elimination half-life
Measured: From administration (Day 1) to Last visit (Day 43)
Apparent clearance
Measured: From administration (Day 1) to Last visit (Day 43)
Apparent volume of distribution at terminal phase
Measured: From administration (Day 1) to Last visit (Day 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start15 Apr 2025
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Victoria Kegel-Hübner, Dr.med., Principal investigator, Charité Research Organisation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076030
- Sponsor's protocol ID
- ZP8396-24059
- Status last verified
- Jan 2026
- First submitted
- 10 Jul 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT07076030
- Acronym / sponsor ID
- ZP8396-24059
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Normal Renal Function | Experimental | Drug: PetrelintideEach participant will receive a single subcutaneous dose of petrelintide on Day 1. |
| Group 2 Mild Renal Impairment | Experimental | Drug: PetrelintideEach participant will receive a single subcutaneous dose of petrelintide on Day 1. |
| Group 3 Moderate Renal Impairment | Experimental | Drug: PetrelintideEach participant will receive a single subcutaneous dose of petrelintide on Day 1. |
| Group 4 Severe Renal Impairment | Experimental | Drug: PetrelintideEach participant will receive a single subcutaneous dose of petrelintide on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PetrelintideAlso: ZP8396Solution administered with a syringe | Drug | Group 1 Normal Renal Function, Group 2 Mild Renal Impairment, Group 3 Moderate Renal Impairment, Group 4 Severe Renal Impairment |
Primary outcome
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
7 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Kegel-Hübner, Dr.med. principal investigator
Charité Research Organisation GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Petrelintide in people with Renal Impairment, run by Zealand Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCo-inf of petrelintide (time frame: From administration (Day 1) to Last visit (Day 43)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.