Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations

NCT07338214 | Completed Phase 1

• 1 other identifier: ZP8396-25041
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Are there differences in how the body absorbs, distributes, metabolises and excretes petrelintide when same single dose petrelintide is given using different concentrations?
2. 2.Are there differences in safety of petrelintide when same single dose petrelintide is given using different concentrations?

Conditions

Obesity & Overweight

Keywords

Pharmacokinetic; Obesity; Overweight; ZP8396; Phase 1; Safety and tolerability

Outcome Measures

Primary Outcomes (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

  Area under the petrelintide plasma concentration time curve from time zero to infinity after a single dose of petrelintide (AUC0-inf)

  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

  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

  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

  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

  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

  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

  Day 1 - day 50 (+/- 2)

Study Arms (4)

Arm A

ACTIVE COMPARATOR

Each participant will receive a single subcutaneous dose of petrelintide strength A on Day 1.

Drug: Petrelintide

Arm B

ACTIVE COMPARATOR

Each participant will receive a single subcutaneous dose of petrelintide strength B on Day 1.

Drug: Petrelintide

Arm C

ACTIVE COMPARATOR

Each participant will receive a single subcutaneous dose of petrelintide strength C on Day 1.

Drug: Petrelintide

Arm D

ACTIVE COMPARATOR

Each participant will receive a single subcutaneous dose of petrelintide strength D on Day 1.

Drug: Petrelintide

Interventions

Petrelintide DRUG

Solution administered with a syringe

Also known as: ZP8396

Arm A; Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Zealand Pharma: lead
• ICON Clinical Research: collaborator

Study Sites (1)

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martha Haidacher

  Charité Research Organisation GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 13, 2026
• Study Start: December 17, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)