Clinical trial • Phase III • Endocrinology

CAGRILINTIDE for Overweight | Obesity

Phase III trial of CAGRILINTIDE for Overweight | Obesity. cagrilintide s.c. 00 mg once weekly versus placebo-controlled. 181 participants.

Overview

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

Key dates

Initial CTIS Submission Date
02-07-2025
First CTIS Authorization Date
07-10-2025

Trial design

cagrilintide s.c. 00 mg once weekly versus placebo-controlled Phase III trial in France, Germany, Italy and others.

Comparator
cagrilintide s.c. 00 mg once weekly versus placebo
Target Sample Size
181

Eligibility

Recruits 181 No vulnerable population selected. Participants must be aged 18 years or above and provide informed consent prior to any study-related activities. There is no assent process described (minors are excluded)..

Vulnerable Population
No vulnerable population selected. Participants must be aged 18 years or above and provide informed consent prior to any study-related activities. There is no assent process described (minors are excluded).

Inclusion criteria

  • {"criterion_text":"- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study."}
  • {"criterion_text":"- Female or male (sex at birth)."}
  • {"criterion_text":"- Age 18 years or above at the time of signing the informed consent."}
  • {"criterion_text":"- History of at least one self-reported unsuccessful dietary effort to lose body weight."}
  • {"criterion_text":"- Body mass index (BMI) ≥ 30.0 kg/m2, or BMI ≥ 27.0 kg/m2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease."}

Exclusion criteria

  • {"criterion_text":"- History of type 1 or type 2 diabetes."}
  • {"criterion_text":"- Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening."}
  • {"criterion_text":"- Previous dosing of marketed or non-marketed amylin-based compounds."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Relative change in body weight.","definition_or_measurement_approach":"Relative change from baseline in body weight."}
  • {"endpoint_text":"- Achievement of ≥ 5% body weight reduction.","definition_or_measurement_approach":"Proportion of participants achieving ≥ 5% reduction in body weight from baseline."}

Secondary endpoints

  • {"endpoint_text":"- Achievement of ≥ 10% body weight reduction.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of ≥ 15% body weight reduction.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in waist circumference.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Ratio to baseline in triglycerides.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Ratio to baseline in hsCRP.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in body weight.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in SF-36v2® mental component summary score.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in IWQOL-Lite-CT total score.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in systolic blood pressure.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in diastolic blood pressure.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Ratio to baseline of: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Free fatty acids CCI CCI","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in glycated haemoglobin (HbA1c).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in fasting plasma glucose.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Ratio to baseline in fasting serum insulin.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of treatment emergent adverse events.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of treatment emergent serious adverse events.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
181
Recruitment Window Months
20
Consent Approach
Informed consent must be obtained before any study-related activities. Participants provide consent themselves (minimum age 18). Subject information and consent documents are provided for adults; no assent for minors is described. Participant-facing and consent materials are available in multiple languages (documents present for German, French, Italian, Norwegian, Polish and English).

Geography

Total Number Of Sites
16
Total Number Of Participants
120

France

Earliest CTIS Part Ii Submission Date
02-09-2025
Latest Decision Or Authorization Date
07-10-2025
Processing Time Days
35
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Centre De Recherche Clinique Portes Du Sud
Contact Person Name
Claire Marx
Contact Person Email
c.marx@lesportesdusud.net
Site Name
Centre Hospitalier Universitaire De Nantes
Contact Person Name
David Jacobi
Contact Person Email
David.Jacobi@univ-nantes.fr

Germany

Earliest CTIS Part Ii Submission Date
26-08-2025
Latest Decision Or Authorization Date
08-10-2025
Processing Time Days
43
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
InnoDiab Forschung GmbH
Contact Person Name
Thomas Schürholz
Contact Person Email
thomas.schuerholz@innodiab.de
Site Name
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Contact Person Name
Thomas Schaum
Contact Person Email
schaum@red-institut.de
Site Name
Gemeinschaftspraxis für Innere Medizin, Diabetologie und Endokrinologie
Contact Person Name
Dominik Dahl
Contact Person Email
Dr.Aberle@dzhw.de

Italy

Earliest CTIS Part Ii Submission Date
23-07-2025
Latest Decision Or Authorization Date
10-10-2025
Processing Time Days
79
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Person Name
Geltrude Mingrone
Contact Person Email
geltrude.mingrone@unicatt.it
Site Name
Ospedale San Raffaele S.r.l.
Contact Person Name
Emanuela Setola
Contact Person Email
setola.emanuela@hsr.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Contact Person Name
Silvio Buscemi
Contact Person Email
silvio.buscemi@unipa.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Contact Person Name
Uberto Pagotto
Contact Person Email
uberto.pagotto@unibo.it

Norway

Earliest CTIS Part Ii Submission Date
30-09-2025
Latest Decision Or Authorization Date
09-10-2025
Processing Time Days
9
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Helse Bergen HF
Contact Person Name
Paal Methlie
Contact Person Email
paal.methlie@helse-bergen.no
Site Name
Drammen Sykehus
Contact Person Name
Stina Therese Sollid
Contact Person Email
stthso@vestreviken.no
Site Name
St. Olavs Hospital HF
Contact Person Name
Hilde Selsås
Contact Person Email
hilde.selsas@stolav.no

Poland

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
28
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Care Clinic Sp. z o.o.
Contact Person Name
Mariola Minkina-Pędras
Contact Person Email
minkina_pedras.mariola@onet.pl
Site Name
NBR Polska Tomasz Klodawski
Contact Person Name
Katarzyna Klodawska
Site Name
Terpa Sp. z o.o. sp.k.
Contact Person Name
Beata Matyjaszek-Matuszek
Contact Person Email
bmm@2com.pl
Site Name
Osteo-Medic s.c. A. Racewicz, J. Supronik
Contact Person Name
Katarzyna Wasilewska
Contact Person Email
k.wasilewska.osteo@gmail.com

Sponsor

Primary sponsor

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

Third parties

  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Special Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Special Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"Special Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"Global Safety Database supplier","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM supplier","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"eCRF supplier:","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
cagrilintide
Active Substance
CAGRILINTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised
Frequency
Once weekly
Investigational Product Name
Placebo
Modality
Other

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