Obesity & OverweightPhase 1NCT07338214
Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations
A Phase 1 study testing Petrelintide in people with Obesity & Overweight, 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 co-morbidities or related diseases. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- 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
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 17 Dec 2025to 31 Mar 2026
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed and dated informed consent obtained before any study-related activities. Study-related activities are any procedures that would not have been done during normal management of the participant
- BMI: ≥27.0 kg/m2, at screening and Day -1
- Have sufficient venous access to allow cannulation for blood sampling as required by the protocol.
- Able and willing to comply with all study procedures
Who cannot join
- HbA1c ≥48 mmol/mol (6.5%)
- Systolic BP ≥160 mmHg or diastolic BP ≥110 mmHg at screening
- History of type 1 or type 2 diabetes mellitus
- Treatment with glucose-lowering agent(s) within 90 days prior to screening
- Obesity induced by an endocrinologic disorder (eg, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity
- Uncontrolled thyroid disease as judged clinically significant by the Investigator
Show all 25Show fewer
- Receipt of any medicinal product under clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this study
- Previous exposure to petrelintide (ZP8396) or exposure to other amylin analogs within the last 3 months
- Evidence of significant neuropsychiatric disease
- Any history or presence of a disorder or a disease, which, in the Investigator's opinion, might jeopardize the participant's safety, evaluation of results, or compliance with the protocol.
- Known or suspected hypersensitivity to study product or related products.
- Known cardiovascular disease (excluding hypertension), including arthrosclerosis, transient ischemic attack, stroke, angina pectoris, or a history of myocardial infarction or coronary arterial bypass graft/percutaneous coronary intervention
- Presence or history of clinically significant arrhythmias or clinically significant conduction disorders
- A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 ms) at screening or Day -1
- A history of additional risk factors for Torsades de pointes (eg, heart failure, hypokalemia, family history of Long QT syndrome)
- The use of concomitant medications that prolong the QT/QTc interval
- 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 gastrectomy) or chronic treatment that affects gastrointestinal motility
- History or presence of malignant neoplasms (except basal or squamous cell skin cancer or cervical carcinoma in situ) within 5 years before the screening as judged by the Investigator
- Planned surgery scheduled during the study period, except for minor surgical procedures, as judged by the Investigator
- Anticipated change in lifestyle (eg, eating, exercise, or sleep pattern) during the study
- Smoking more than 5 cigarettes or the equivalent nicotine consumption per day (including use of nicotine preparations)
- Inability or unwillingness to refrain from smoking and use of nicotine substitute products 1 day before and during the inpatient period
- Any use of chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, single intraarticular injection, or inhaled preparations) within 90 days of screening
- Any medication (prescription and non-prescription drugs) except for stable treatment with antihypertensive and lipid-lowering drugs as well as thyroid replacement therapy, unless approved by the medical monitor in consultation with the Sponsor (Note: Stable treatment with antihypertensive and lipid lowering drugs (stable for ≥1 month prior to screening) as well as thyroid replacement therapy (≥2 months prior to screening) will be allowed. Use of routine vitamins, topical treatments (including local acting steroids/antihistamines for the treatment of mild hay fever), menopausal hormone replacement therapy, and contraceptives are allowed. In addition, occasional use of acetylsalicylic acid, paracetamol, and ibuprofen for acute pain treatment is allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations in Participants With a BMI ≥27.0 kg/m²
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 co-morbidities or related diseases.
The goal is to learn how the same single dose of petrelintide, given using different concentrations, works in the body when given to participants with a BMI at, or above, 27kg/m2.
Read more
The main questions it aims to answer are:
- Are there differences in how the body absorbs, distributes, metabolises and excretes petrelintide when same single dose petrelintide is given using different concentrations?
- Are there differences in safety of petrelintide when same single dose petrelintide is given using different concentrations?
Participants will:
Visit the study center 10 times for tests and blood sampling (9 day ambulatory visits and 1 in-house visit of 4 consecutive days with sleeping 3 nights at the study center).
Petrelintide will be given once as a single injection in a skin fold of the abdomen on Day 1. The participants will be monitored until approximately Day 50.
Read the detailed description
This is an open-label, single-center, randomized, parallel-group study designed to investigate the pharmacokinetic (PK) profiles, safety, and tolerability of a single dose administration of petrelintide administered subcutanously (SC) using 4 different drug product concentrations. The study will be conducted in participants who have a body mass index (BMI) ≥27.0 kg/m2, who will be stratified to 2 cohorts by BMI at randomization (≤38 vs >38, with 40% cap in each group).
Approximately 48 participants are needed for the study.
- Conditions
- Obesity & Overweight
- Being tested
- Petrelintide
- Keywords
- Pharmacokinetic, Obesity, Overweight, ZP8396, Phase 1, Safety and tolerability
- Medical subject headings
- Obesity, Overweight
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 |
|---|---|---|
| Arm A | Active comparator | Each participant will receive a single subcutaneous dose of petrelintide strength A on Day 1. Receives: Drug: Petrelintide |
| Arm B | Active comparator | Each participant will receive a single subcutaneous dose of petrelintide strength B on Day 1. Receives: Drug: Petrelintide |
| Arm C | Active comparator | Each participant will receive a single subcutaneous dose of petrelintide strength C on Day 1. Receives: Drug: Petrelintide |
| Arm D | Active comparator | Each participant will receive a single subcutaneous dose of petrelintide strength D on Day 1. Receives: Drug: Petrelintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Area under the petrelintide plasma concentration time curve from time zero to infinity after a single dose of petrelintide (AUC0-inf)
Measured: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Maximum observed plasma concentration (Cmax) from time zero to infinity after a single dose of petrelintide
Measured: Day 1 - day 50 (+/- 2)
Secondary outcomes (5)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Area under the petrelintide plasma concentration time curve from time zero to last measurable concentration after a single dose of petrelintide (AUC0-t)
Measured: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time to maximum observed petrelintide plasma concentration after a single dose of petrelintide (Tmax)
Measured: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Terminal elimination half-life for petrelintide after a single dose of petrelintide (t1/2)
Measured: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Apparent clearance of petrelintide after a single dose of petrelintide (CL/F)
Measured: Day 1 - day 50 (+/- 2)
To investigate the safety and tolerability of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Incidence of treatment-emergent adverse events (TEAEs) from dosing (Day 1) to end of follow-up
Measured: Day 1 - day 50 (+/- 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start17 Dec 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Martha Haidacher, Principal investigator, Charité Research Organisation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338214
- Sponsor's protocol ID
- ZP8396-25041
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations in Participants With a BMI ≥27.0 kg/m²
- ClinicalTrials.gov ID
- NCT07338214
- Acronym / sponsor ID
- ZP8396-25041
- Conditions
- Obesity & Overweight
- Keywords
- Pharmacokinetic, Obesity, Overweight, ZP8396, Phase 1, Safety and tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 13 Jan 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 study is testing the study compound petrelintide that is being developed for the weight management in people with obesity or overweight with co-morbidities or related diseases.
The goal is to learn how the same single dose of petrelintide, given using different concentrations, works in the body when given to participants with a BMI at, or above, 27kg/m2.
The main questions it aims to answer are:
- Are there differences in how the body absorbs, distributes, metabolises and excretes petrelintide when same single dose petrelintide is given using different concentrations?
- Are there differences in safety of petrelintide when same single dose petrelintide is given using different concentrations?
Participants will:
Visit the study center 10 times for tests and blood sampling (9 day ambulatory visits and 1 in-house visit of 4 consecutive days with sleeping 3 nights at the study center).
Petrelintide will be given once as a single injection in a skin fold of the abdomen on Day 1. The participants will be monitored until approximately Day 50.
Detailed description
This is an open-label, single-center, randomized, parallel-group study designed to investigate the pharmacokinetic (PK) profiles, safety, and tolerability of a single dose administration of petrelintide administered subcutanously (SC) using 4 different drug product concentrations. The study will be conducted in participants who have a body mass index (BMI) ≥27.0 kg/m2, who will be stratified to 2 cohorts by BMI at randomization (≤38 vs >38, with 40% cap in each group).
Approximately 48 participants are needed for the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: PetrelintideEach participant will receive a single subcutaneous dose of petrelintide strength A on Day 1. |
| Arm B | Active comparator | Drug: PetrelintideEach participant will receive a single subcutaneous dose of petrelintide strength B on Day 1. |
| Arm C | Active comparator | Drug: PetrelintideEach participant will receive a single subcutaneous dose of petrelintide strength C on Day 1. |
| Arm D | Active comparator | Drug: PetrelintideEach participant will receive a single subcutaneous dose of petrelintide strength D on Day 1. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed and dated informed consent obtained before any study-related activities. Study-related activities are any procedures that would not have been done during normal management of the participant
- BMI: ≥27.0 kg/m2, at screening and Day -1
- Have sufficient venous access to allow cannulation for blood sampling as required by the protocol.
- Able and willing to comply with all study procedures
Key exclusion criteria (25 listed)
- HbA1c ≥48 mmol/mol (6.5%)
- Systolic BP ≥160 mmHg or diastolic BP ≥110 mmHg at screening
- History of type 1 or type 2 diabetes mellitus
- Treatment with glucose-lowering agent(s) within 90 days prior to screening
- Obesity induced by an endocrinologic disorder (eg, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity
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 | Arm A, Arm B, Arm C, Arm D |
Primary outcome
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame: Day 1 - day 50 (+/- 2)
Area under the petrelintide plasma concentration time curve from time zero to infinity after a single dose of petrelintide (AUC0-inf)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame: Day 1 - day 50 (+/- 2)
Maximum observed plasma concentration (Cmax) from time zero to infinity after a single dose of petrelintide
5 secondary outcomes
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame: Day 1 - day 50 (+/- 2)
To investigate the safety and tolerability of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time frame: Day 1 - day 50 (+/- 2)
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 8 Apr 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.
Martha Haidacher 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 Obesity & Overweight, 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 4 inclusion and 25 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 8 Apr 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?
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity (time frame: Day 1 - day 50 (+/- 2)). The study lists 2 primary outcomes in all. 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 8 Apr 2026.