Clinical trial • Phase III • Endocrinology

cagrilintide and semaglutide for Obesity

Phase III trial of cagrilintide and semaglutide for Obesity. 100 participants.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Obesity
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
05-12-2025
First CTIS Authorization Date
06-03-2026

Trial design

Phase III trial across 1 site in Denmark.

Target Sample Size
100
Trial Duration For Participant
791

Recruitment

Planned Sample Size
100
Recruitment Window Months
26

Geography

Total Number Of Sites
1
Total Number Of Participants
100

Denmark

Earliest CTIS Part Ii Submission Date
30-01-2026
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
35
Number Of Sites
1
Number Of Participants
100

Sites

Site Name
Region Midtjylland
Department Name
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Principal Investigator Name
Niels Jessen
Principal Investigator Email
niels.jessen@biomed.au.dk
Contact Person Name
Niels Jessen
Contact Person Email
niels.jessen@biomed.au.dk

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
CagriSema
Active Substance
cagrilintide and semaglutide
Modality
Peptide/protein/enzyme
Investigational Product Name
cagrilintide
Active Substance
cagrilintide
Modality
Peptide/protein/enzyme
Investigational Product Name
semaglutide
Active Substance
semaglutide
Modality
Peptide/protein/enzyme
Combination Treatment
Yes

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