Impaired Hepatic FunctionPhase 1NCT07682818
Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
A Phase 1 study testing Petrelintide in people with Impaired Hepatic Function, run by Zealand Pharma at 3 sites in 2 countries.
Trial summary
This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Hepatic Function
- 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
- 36 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 May 2026to 12 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants:
- Sex: male and female participants.
- Body mass index (BMI): 18.5 to 40.0 kg/m^2, inclusive, at screening.
- Additional Inclusion Criteria for Participants with Normal Hepatic Function
- Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..
- Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.
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- Additional Inclusion Criteria for Participants with Hepatic Impairment
- Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
- Participants should be otherwise judged to be in acceptable health (type 2 diabetes mellitus [T2DM] is allowed) in the opinion of the Investigator based on a medical evaluation (including a physical examination, medical history, electrocardiogram [ECG], vital signs, concomitant medication and the results of laboratory safety tests) performed during the screening visit.
- Participants with T2DM may be enrolled if they have/are: a. Hemoglobin A1c ≤11% at screening b. On a stable regimen for at least 8 weeks prior to screening, defined as: stable diet and exercise program, and/or, stable dose of metformin, and/or, stable dose of a sodium-glucose cotransporter-2 inhibitor.
Who cannot join
- All participants:
- Known or suspected hypersensitivity to the IMP or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Slovakia2 sites, 2 recruiting
- Recruiting
Summit Clinical Research s.r.o.
Bratislava, Bratislava Region, 831 01
Viera Kupčová, Dr., +421905286213, viera.kupcova@summit-cr.eu
- Recruiting
Summit Clinical Research s.r.o.
Malacky, Malacky, 901 01
Edita Kadlubiaková, Dr., +421905434699, edita.kadlubiakova@summit-cr.eu
Poland1 site, 1 recruiting
- Recruiting
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Wroclaw, Poland, 51-162
Piotr Napora, Dr., +483267900, napora.piotr@cbk.wroc.pl
About this study
Official title: Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function
This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities.
The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.
Read the detailed description
This is a Phase 1, open-label, multicenter, single-dose, parallel-group, non-randomized trial to evaluate the PK, safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe HI, and participants with normal hepatic function. Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.
Each participant will receive a single subcutaneous (SC) dose of petrelintide on Day 1.
Up to 18 participants with normal hepatic function and 18 participants with HI (6 participants each in the following groups: mild, moderate, or severe HI) will participate in this trial.
- Conditions
- Impaired Hepatic Function
- Being tested
- Petrelintide
- Keywords
- HI, Impaired Hepatic Function, Petrelintide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PetrelintideDrug
Also called ZP8396
Petrelintide will be administered as a single SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Petrelintide: Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single SC dose of petrelintide. Receives: Drug: Petrelintide |
| Petrelintide: Mild HI | Experimental | Participants with mild HI will receive a single SC dose of petrelintide. Receives: Drug: Petrelintide |
| Petrelintide: Moderate HI | Experimental | Participants with moderate HI will receive a single SC dose of petrelintide. Receives: Drug: Petrelintide |
| Petrelintide: Severe HI | Experimental | Participants with severe HI will receive a single SC dose of petrelintide. Receives: Drug: Petrelintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
Measured: Day 1 (pre-dose) to Day 50 (Follow-up)
Secondary outcomes (7)
AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide
Measured: Day 1 (pre-dose) to Day 50 (Follow-up)
Maximum Observed Plasma Concentration (Cmax) of Petrelintide
Measured: Day 1 (pre-dose) to Day 50 (Follow-up)
Time to Cmax (tmax)
Measured: Day 1 (pre-dose) to Day 50 (Follow-up)
Apparent Clearance (CL/F) of Petrelintide
Measured: Day 1 (pre-dose) to Day 50 (Follow-up)
Terminal Elimination Half-life (t1/2) of Petrelintide
Measured: Day 1 (pre-dose) to Day 50 (Follow-up)
Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide
Measured: Day 1 (pre-dose) to Day 50 (Follow-up)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 up to Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start18 May 2026
- Primary completion12 Apr 2027 (estimated)
- Study completion12 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Hepatic FunctionStudies 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Information Desk, Principal investigator, Zealand Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682818
- Sponsor's protocol ID
- ZP8396-25077
- Other IDs
- 2025-523641-10-00, Universal Trial number, 2025
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 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 Hepatic Function
- ClinicalTrials.gov ID
- NCT07682818
- Acronym / sponsor ID
- ZP8396-25077
- Conditions
- Impaired Hepatic Function
- Keywords
- HI, Impaired Hepatic Function, Petrelintide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 12 Apr 2027 (estimated)
- Study completion
- 12 Apr 2027 (estimated)
- First posted
- 6 Jul 2026 (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 trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities.
The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.
Detailed description
This is a Phase 1, open-label, multicenter, single-dose, parallel-group, non-randomized trial to evaluate the PK, safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe HI, and participants with normal hepatic function. Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.
Each participant will receive a single subcutaneous (SC) dose of petrelintide on Day 1.
Up to 18 participants with normal hepatic function and 18 participants with HI (6 participants each in the following groups: mild, moderate, or severe HI) will participate in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Petrelintide: Normal Hepatic Function | Experimental | Drug: PetrelintideParticipants with normal hepatic function will receive a single SC dose of petrelintide. |
| Petrelintide: Mild HI | Experimental | Drug: PetrelintideParticipants with mild HI will receive a single SC dose of petrelintide. |
| Petrelintide: Moderate HI | Experimental | Drug: PetrelintideParticipants with moderate HI will receive a single SC dose of petrelintide. |
| Petrelintide: Severe HI | Experimental | Drug: PetrelintideParticipants with severe HI will receive a single SC dose of petrelintide. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sex: male and female participants.
- Body mass index (BMI): 18.5 to 40.0 kg/m^2, inclusive, at screening.
- Additional Inclusion Criteria for Participants with Normal Hepatic Function
- Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..
- Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to the IMP or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
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: ZP8396Petrelintide will be administered as a single SC injection. | Drug | Petrelintide: Mild HI, Petrelintide: Moderate HI, Petrelintide: Normal Hepatic Function, Petrelintide: Severe HI |
Primary outcome
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
Time frame: Day 1 (pre-dose) to Day 50 (Follow-up)
7 secondary outcomes
AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide
Time frame: Day 1 (pre-dose) to Day 50 (Follow-up)
Maximum Observed Plasma Concentration (Cmax) of Petrelintide
Time frame: Day 1 (pre-dose) to Day 50 (Follow-up)
Time to Cmax (tmax)
Time frame: Day 1 (pre-dose) to Day 50 (Follow-up)
Apparent Clearance (CL/F) of Petrelintide
Time frame: Day 1 (pre-dose) to Day 50 (Follow-up)
Terminal Elimination Half-life (t1/2) of Petrelintide
Time frame: Day 1 (pre-dose) to Day 50 (Follow-up)
Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide
Time frame: Day 1 (pre-dose) to Day 50 (Follow-up)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 50
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Hepatic Impairment
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.
Clinical Trial Information Desk principal investigator
Zealand Pharma A/S
3 sites in 2 countries: 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 Impaired Hepatic Function, run by Zealand Pharma at 3 sites in 2 countries.
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 10 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovakia, Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Information Desk (+4588773600, clinicaltrials@zealandpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide (time frame: Day 1 (pre-dose) to Day 50 (Follow-up)). 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 6 Jul 2026.