PHARMACOKINETICS OF PETRELINTIDE FOLLOWING ADMINISTRATION TO PARTICIPANTS WITH IMPAIRED HEPATIC FUNCTION

Start 18 May 2026 · Status Ongoing, recruiting · 2 EU/EEA countries · 3 sites · Protocol ZP8396-25077

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ongoing, recruiting

Participants planned 36

Countries 2

Sites 3

Healthy / hepatic impaired volunteers only study to assess PK parameters

Key facts

Sponsor: Zealand Pharma A/S
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Not possible to specify
Trial duration: 18 May 2026 → ongoing
Decision date (initial): 2026-05-07
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2025-523641-10-00
WHO UTN: U1111-1328-8578

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Healthy / hepatic impaired volunteers only study to assess PK parameters

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Zealand Pharma A/S

Sponsor organisation: Zealand Pharma A/S
Address: Sydmarken 11
City: Soeborg
Postcode: 2860
Country: Denmark

Scientific contact point

Organisation: Zealand Pharma A/S
Contact name: Clinical Trial Information Desk

Public contact point

Organisation: Zealand Pharma A/S
Contact name: Clinical Trial Information Desk

Locations

2 EU/EEA countries · 3 investigational sites

By country

Country	MS status	Planned subjects	Sites
Poland	Ongoing, recruiting	18	1
Slovakia	Ongoing, recruiting	18	2
Rest of world	—	0	—

Investigational sites

Poland

1 site · Ongoing, recruiting

Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.

Centrum Badań Klinicznych Ośrodek Badań Wczesnej Fazy, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw

Slovakia

2 sites · Ongoing, recruiting

Summit Clinical Research s.r.o.

N/A, Duklianskych Hrdinov 34, 901 01, Malacky