A three-part first-in-human trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of GUB-UCN2 in healthy lean and obese participants and participants with T2D

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol GUB-UCN2

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruitment pending

Participants planned 220

Countries 1

Sites 1

Type 2 Diabetes

Key facts

Sponsor: Gubra A/S
Participant type: Healthy volunteers, Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Decision date (initial): 2026-05-11
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Type 2 Diabetes

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gubra A/S

Sponsor organisation: Gubra A/S
Address: Hoersholm Kongevej 11b
City: Hoersholm
Postcode: 2970
Country: Denmark

Scientific contact point

Organisation: Gubra A/S
Contact name: Drug Development

Public contact point

Organisation: Gubra A/S
Contact name: Drug Development

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Authorised, recruitment pending	220	1
Rest of world	—	0	—

Investigational sites

Germany

1 site · Authorised, recruitment pending

PROFIL Institut fuer Stoffwechselforschung GmbH

n/a, Hellersbergstrasse 9, Hammfeld, Neuss

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-02-25	Germany	Acceptable 2026-04-23	2026-05-11
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2026-05-11	Germany	Acceptable 2026-04-23	2026-05-11