Clinical trial • Phase III • Endocrinology

semaglutide for Type 1 diabetes

Phase III trial of semaglutide for Type 1 diabetes. 96 participants.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Type 1 diabetes
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme|Other

Key dates

Initial CTIS Submission Date
04-04-2025
First CTIS Authorization Date
28-05-2025

Trial design

Phase III trial across 1 site in Germany.

Target Sample Size
96

Eligibility

Recruits 96 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent or assent handling are provided in the CTIS record..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent or assent handling are provided in the CTIS record.

Recruitment

Planned Sample Size
96
Recruitment Window Months
14
Consent Approach
Not specified in CTIS record.

Geography

Total Number Of Sites
1
Total Number Of Participants
96

Germany

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
28-10-2025
Processing Time Days
165
Number Of Sites
1
Number Of Participants
96

Sites

Site Name
PROFIL Institut fuer Stoffwechselforschung GmbH
Contact Person Name
Grit Andersen
Contact Person Email
grit.andersen@profil.com

Sponsor

Primary sponsor

Full Name
Novo Nordisk A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Investigational products

Investigational Product Name
NNC0194-0499
Modality
Other
Investigational Product Name
semaglutide
Active Substance
semaglutide
Modality
Peptide/protein/enzyme
Combination Treatment
Yes

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