Clinical trial • Phase III • Endocrinology

Cagrilintide for Obesity | Postmenopausal state

Phase III trial of Cagrilintide for Obesity | Postmenopausal state. 144 participants.

Overview

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

Key dates

Initial CTIS Submission Date
13-12-2024
First CTIS Authorization Date
21-03-2025

Trial design

Phase III trial across 1 site in Denmark.

Target Sample Size
144

Eligibility

Recruits 144 Vulnerable population not selected; participants are adult post‑menopausal females (50-70 years). No specific consent or assent handling described..

Vulnerable Population
Vulnerable population not selected; participants are adult post‑menopausal females (50-70 years). No specific consent or assent handling described.

Inclusion criteria

  • {"criterion_text":"- Female (aged between 50-70 years (both included)) with obesity (BMI ≥ 30.0 kg/m2) of post-menopausal state at screening (defined as minimum 12 months of amenorrhea and high levels of follicular stimulating hormone (FSH) ≥16 UI/L. In cases of uncertainty, confirmation of postmenopausal status requires low levels of anti-Müllerian hormone (AMH) and inhibin B)."}

Recruitment

Planned Sample Size
144
Recruitment Window Months
30

Geography

Total Number Of Sites
1
Total Number Of Participants
144

Denmark

Earliest CTIS Part Ii Submission Date
12-03-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
380
Number Of Sites
1
Number Of Participants
144

Sites

Site Name
Steno Diabetes Center Copenhagen
Principal Investigator Name
Jonatan Ising Bagger
Principal Investigator Email
jonatan.ising.bagger@regionh.dk
Contact Person Name
Jonatan Ising Bagger
Number Of Participants
144

Sponsor

Primary sponsor

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

Third parties

  • {"country":"Denmark","full_name":"Steno Diabetes Center Copenhagen","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}

Co-sponsors

  • Steno Diabetes Center Copenhagen

Investigational products

Investigational Product Name
Cagrilintide
Active Substance
Cagrilintide
Modality
Peptide/protein/enzyme

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