Clinical trial • Phase III • Endocrinology

cagrilintide (NNC0174-0833) | semaglutide (NNC0113-0217) for Overweight | Obesity

Phase III trial of cagrilintide (NNC0174-0833) | semaglutide (NNC0113-0217) for Overweight | Obesity.

Overview

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

Key dates

Initial CTIS Submission Date
15-04-2024
First CTIS Authorization Date
22-05-2024

Trial design

Placebo; Semaglutide (comparator; dose/schedule not specified in provided data); Cagrilintide (comparator; dose/schedule not specified in provided data)-controlled Phase III trial across 80 sites in Spain, Finland, Belgium and others.

Comparator
Placebo; Semaglutide (comparator; dose/schedule not specified in provided data); Cagrilintide (comparator; dose/schedule not specified in provided data)
Target Sample Size
2314

Eligibility

Recruits 2314 Vulnerable population not selected; participants must be adults (age ≥ 18) and provide their own informed consent..

Vulnerable Population
Vulnerable population not selected; participants must be adults (age ≥ 18) and provide their own informed consent.

Inclusion criteria

  • {"criterion_text":"- Male or female"}
  • {"criterion_text":"- Age above or equal to 18 years at the time of signing informed consent"}
  • {"criterion_text":"- a) BMI ≥ 30.0 kg/m2 or b) BMI ≥ 27.0 kg/m2 with the presence of at least one obesity-related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease"}

Exclusion criteria

  • {"criterion_text":"- HbA1c ≥ 6.5 % (48 mmol/mol) as measured by the central laboratory at screening"}
  • {"criterion_text":"- History of type 1 or type 2 diabetes mellitus"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Relative change in body weight","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of ≥ 5% weight reduction","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Achievement of ≥ 20% weight reduction","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of ≥ 25% weight reduction","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of ≥ 30% weight reduction","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Relative change in body weight","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in waist circumference","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in systolic blood pressure (SBP)","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 SF-36 V2 Health Survey Acute (SF-36v2) Physical Functioning score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Treatment-emergent Adverse Events (TEAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Treatment-emergent Serious adverse events (TESAEs)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
2314
Recruitment Window Months
35
Consent Approach
Informed consent required from participants (age ≥18). Country-specific subject information and informed consent forms are provided (multiple languages/translations available as indicated in document list).

Methods

  • Direct to Patient recruitment (appears in sponsor third-party duties and country-specific SI-IC documents; e.g. Marken Limited listed with duty 'Direct to Patient' and several country SI-IC documents labelled 'Direct To Patient' or 'Direct Shipment of IMP')

Geography

Total Number Of Sites
80
Total Number Of Participants
1101

Spain

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
19-03-2025
Processing Time Days
324
Number Of Sites
7
Number Of Participants
69

Sites

Site Name
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Contact Person Name
Alberto Aliaga Verdugo
Contact Person Email
a.aliaga@ntde.es
Site Name
Hospital General Universitario Gregorio Maranon
Contact Person Name
Olga González Albarrán
Contact Person Email
ogonzaleza@salud.madrid.org
Site Name
Area De Salud De Leon Y El Bierzo
Contact Person Name
María Ballesteros Pomar
Site Name
Hospital Clinic De Barcelona
Contact Person Name
Ana de Hollanda
Contact Person Email
endotrials@clinic.cat
Site Name
Clinica Universidad De Navarra
Contact Person Name
Javier Escalada
Contact Person Email
fescalada@unav.es
Site Name
Hospital Nisa Sevilla Aljarafe
Contact Person Name
Cristobal Morales Portillo
Contact Person Email
moralesPCJ@vithas.es
Site Name
Hospital Quironsalud Infanta Luisa
Contact Person Name
Margarita Rivas Fernández

Finland

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
19-03-2025
Processing Time Days
324
Number Of Sites
4
Number Of Participants
101

Sites

Site Name
Oulu University Hospital
Contact Person Name
Janne Hukkanen
Contact Person Email
janne.hukkanen@oulu.fi
Site Name
Health Step Finland Oy
Contact Person Name
Timo Lakka
Contact Person Email
timo.lakka@uef.fi
Site Name
HUS-Yhtymae
Contact Person Name
Kirsi Pietiläinen
Contact Person Email
kirsi.pietilainen@helsinki.fi
Site Name
Turku University Hospital
Contact Person Name
Heidi Immonen
Contact Person Email
heidi.immonen@varha.fi

Belgium

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
14-03-2025
Processing Time Days
319
Number Of Sites
6
Number Of Participants
75

Sites

Site Name
Universitair Ziekenhuis Gent
Contact Person Name
Guy T'Sjoen
Contact Person Email
guy.tsjoen@ugent.be
Site Name
UZ Leuven
Contact Person Name
Roman Vangoitsenhoven
Site Name
Imelda
Contact Person Name
Chris Vercammen
Contact Person Email
chris.vercammen@imelda.be
Site Name
Antwerp University Hospital
Contact Person Name
Eveline Dirinck
Contact Person Email
eveline.dirinck@uza.be
Site Name
CHU Helora
Contact Person Name
Ides Colin
Contact Person Email
ides.michel.colin@helora.be
Site Name
Cliniques Universitaires Saint-Luc
Contact Person Name
Audrey Loumaye

Bulgaria

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
18-03-2025
Processing Time Days
323
Number Of Sites
15
Number Of Participants
177

Sites

Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Department Name
Endocrinology and Metabolic Diseases Consulting Room
Contact Person Name
Katya Kurteva-Hristova
Contact Person Email
katiakurteva@abv.bg
Site Name
Diagnostichno-Konsultativen Tsentar XVIII-Sofia OOD
Department Name
Cabinet №40
Contact Person Name
Aleksandra Traykovska-Dimitrova
Contact Person Email
dr.trajkovska@yahoo.com
Site Name
Alexandrovska University Hospital
Department Name
Department of Clinical Densitometry and Bone Metabolic Diseases
Contact Person Name
Plamen Popivanov
Contact Person Email
ppopivanov@abv.bg
Site Name
Outpatient Clinic For Individual Practice For Specialized Outpatient Medical Care Endocrinology Nt EOOD
Contact Person Name
Tatyana Kamenova
Contact Person Email
tania_nk@abv.bg
Site Name
Diagnostic And Consulting Center East Ltd.
Department Name
Cabinet №11
Contact Person Name
Vera Naldzhieva
Contact Person Email
veronitkata@abv.bg
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Clinic of endocrinology and metabolic disease for metabolic disorders treatment
Contact Person Name
Daniela Popova
Contact Person Email
danielapopovabg@yahoo.com
Site Name
Asclepius Medical Center OOD
Department Name
Endocrinology and Metabolic Diseases Consulting Room
Contact Person Name
Kiril Kirilov
Contact Person Email
drkirilkirilov68@gmail.com
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
Department of Internal diseases
Contact Person Name
Anita Shanina-Yordanova
Contact Person Email
dr.shanina@mbalpuls.bg
Site Name
Outpatient Clinic For Specialized Outpatient Medical Care in Endocrinology and Metabolic Diseases
Contact Person Name
Antoanela Petrova-Gancheva
Contact Person Email
a.slavcheva@abv.bg
Site Name
Medical Center Berbatov Ltd.
Contact Person Name
Dimitar Berbatov
Contact Person Email
dimitar_berbatov@mail.bg
Site Name
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD
Department Name
Ground floor
Contact Person Name
Albena Dinkova
Contact Person Email
a.dinkova@abv.bg
Site Name
Ambulatory For Individual Practice And Specialized Medical Aid Dr. Artin Magardichian Ltd.
Department Name
Consulting room 402 A
Contact Person Name
Artin Magardichyan
Contact Person Email
artinmagardichan@gmail.com
Site Name
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
Department Name
First Clinic of Endocrinology and Metabolic Diseases
Contact Person Name
Ralitsa Robeva
Contact Person Email
rali_robeva@yahoo.com
Site Name
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
Department Name
Second Clinic of Endocrinology and Metabolic Diseases
Contact Person Name
Tsvetalina Tankova
Contact Person Email
tankova@iname.com
Site Name
Nader Yabrudi - ambulatory for specialized medical care of internal diseases and endocrinology
Department Name
Room 11
Contact Person Name
Nader Mohamed Said Yabrudi
Contact Person Email
nader_65@abv.bg

Poland

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
19-03-2025
Processing Time Days
324
Number Of Sites
15
Number Of Participants
187

Sites

Site Name
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP
Contact Person Name
Piotr Jankowski
Contact Person Email
piotrjankowski@interia.pl
Site Name
Centrum Kardiometaboliczne Gierach-Med Marcin Gierach
Contact Person Name
Marcin Gierach
Contact Person Email
marcin_gierach@wp.pl
Site Name
Terpa Sp. z o.o. S.K.
Contact Person Name
Beata Matyjaszek-Matuszek
Contact Person Email
bmm@2com.pl
Site Name
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
Contact Person Name
Barbara Sorobka
Contact Person Email
b.sorobka@wp.pl
Site Name
Centrum Zdrowia Metabolicznego
Contact Person Name
Pawel Bogdanski
Contact Person Email
pawelbogdanski73@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne
Contact Person Name
Michal Hoffmann
Contact Person Email
michalhoffmann@gumed.edu.pl
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Contact Person Name
Katarzyna Palka
Contact Person Email
palka.trials@gmail.com
Site Name
50BIO.COM sp. z o.o., Przychodnia "Przy Szpitalu"
Contact Person Name
Radoslaw Wieczor
Contact Person Email
przychodnia@przyszpitalu.pl
Site Name
Klinika Bellamed
Contact Person Name
Gabriel Rucinski
Contact Person Email
gabrielrucinski@gmail.com
Site Name
Instytut Diabetologii Sp. z o.o.
Contact Person Name
Ewa Pankowska
Site Name
Centrum Ginekologii Poloznictwa I Leczenia Nieplodnosci Pastelova Sp z.o.o.
Contact Person Name
Robert Spaczynski
Contact Person Email
rspaczynski@yahoo.com
Site Name
Gabinet Leczenia Otyłości i Chorób Dietozależnych
Contact Person Name
Lucyna Ostrowska
Contact Person Email
lucyna.ostrowska@umb.edu.pl
Site Name
Salvia Lekston I Madej Sp. J.
Contact Person Name
Andrzej Madej
Contact Person Email
andrzejmadej@tlen.pl
Site Name
Niepubliczny Zakład Opieki Zdrowotnej Vita-Diabetica Małgorzata Buraczyk
Contact Person Name
Malgorzata Buraczyk
Contact Person Email
badaniaburaczyk@wp.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Contact Person Name
Adam Kretowski
Contact Person Email
adam.kretowski@umb.edu.pl

Germany

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
19-03-2025
Processing Time Days
324
Number Of Sites
9
Number Of Participants
113

Sites

Site Name
MVZ DiaMedicum Bad Mergentheim GmbH
Contact Person Name
Simon Vidal
Contact Person Email
Vidal@diabetespraxis.de
Site Name
Institut fuer Diabetesforschung Muenster GmbH
Contact Person Name
Ludger Rose
Contact Person Email
l.rose@diabetes-muenster.de
Site Name
Universitaet Leipzig
Contact Person Name
Matthias Blüher
Site Name
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Contact Person Name
Andreas Hagenow
Contact Person Email
a.hagenow@zks-sbb.com
Site Name
MZM Praxis Drs. Erlinger
Contact Person Name
Moritz Mauro Erlinger
Contact Person Email
mzm@moenchfeld.de
Site Name
Zentrum für klinische Forschung Allgäu Oberschwaben
Contact Person Name
Joachim Sauter
Contact Person Email
joachim@dr-sauter-wangen.de
Site Name
Wendisch/Dahl Hamburg
Contact Person Name
Jens Aberle
Contact Person Email
Dr.Aberle@dzhw.de
Site Name
InnoDiab Forschung GmbH
Contact Person Name
Thomas Schürholz
Contact Person Email
thomas.schuerholz@innodiab.de
Site Name
Ambenet GmbH Das Ambulante Behandlungsnetz
Contact Person Name
Hans-Detlev Stahl
Contact Person Email
ds@ambenet.de

Netherlands

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
18-03-2025
Processing Time Days
323
Number Of Sites
5
Number Of Participants
101

Sites

Site Name
Bravis Ziekenhuis
Contact Person Name
I Rietveld
Contact Person Email
i.rietveld@bravis.nl
Site Name
Albert Schweitzer Ziekenhuis
Contact Person Name
Simone Hartong
Contact Person Email
s.c.c.hartong@asz.nl
Site Name
Spaarne Gasthuis Stichting
Contact Person Name
Victor Gerdes
Contact Person Email
vgerdes@spaarnegasthuis.nl
Site Name
Academisch Medisch Centrum
Contact Person Name
Sarah Siegelaar
Contact Person Email
endocrinologie@amsterdamumc.nl
Site Name
Rijnstate Ziekenhuis Stichting
Contact Person Name
Arianne van Bon
Contact Person Email
ACvanBon@rijnstate.nl

France

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
18-03-2025
Processing Time Days
323
Number Of Sites
5
Number Of Participants
62

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Contact Person Name
David Jacobi
Contact Person Email
David.Jacobi@univ-nantes.fr
Site Name
Centre De Recherche Clinique Portes Du Sud
Contact Person Name
Claire MARX
Contact Person Email
c.marx@lesportesdusud.net
Site Name
Hospices Civils De Lyon
Contact Person Name
Emmanuel DISSE
Contact Person Email
emmanuel.disse@chu-lyon.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Contact Person Name
Alain Pradignac
Site Name
Assistance Publique Hopitaux De Paris
Contact Person Name
Christine Poitou-Bernert

Italy

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
24-06-2025
Processing Time Days
421
Number Of Sites
9
Number Of Participants
126

Sites

Site Name
Azienda Ospedaliera Universitaria Senese
Contact Person Name
Maria Grazia Castagna
Contact Person Email
mariagrazia.castagna@nisi.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
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Contact Person Name
Andrea Isidori
Contact Person Email
andrea.isidori@uniroma1.it
Site Name
IRCCS Policlinico San Donato
Contact Person Name
Alexis Malavazos
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Contact Person Name
Dario Tuccinardi
Site Name
Azienda Ospedale-Universita Padova
Contact Person Name
Alessandro Scarda
Site Name
Azienda Ospedaliera Universitaria Mater Domini
Contact Person Name
Francesco Andreozzi
Contact Person Email
andreozzif@unicz.it
Site Name
Ospedale Garibaldi
Contact Person Name
Lucia Frittitta
Contact Person Email
lfritti@unict.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Contact Person Name
Paolo Sbraccia
Contact Person Email
sbraccia@med.uniroma2.it

Denmark

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
23-06-2025
Processing Time Days
420
Number Of Sites
5
Number Of Participants
90

Sites

Site Name
Hvidovre Hospital
Contact Person Name
Carsten Dirksen
Contact Person Email
carsten.dirksen@regionh.dk
Site Name
Esbjerg Og Grindsted Sygehus
Contact Person Name
Claus Bogh Juhl
Contact Person Email
Claus.Bogh.Juhl@rsyd.dk
Site Name
Gentofte Hospital
Contact Person Name
Asger Bach Lund
Contact Person Email
Asger.Lund.01@regionh.dk
Site Name
Aarhus Universitetshospital
Contact Person Name
Jens Meldgaard Bruun
Contact Person Email
jensbruu@rm.dk
Site Name
Region Sjaelland
Contact Person Name
Leif Breum
Contact Person Email
lbru@regionsjaelland.dk

Sponsor

Primary sponsor

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

Contract research organisations

Name
Oracle America Inc.
Responsibilities
CRF Supplier
Name
4G Clinical B.V.
Responsibilities
RTSM and RTSM Help center
Name
Q Squared Solutions Limited
Responsibilities
Role code 4 (unspecified in provided data)
Name
IQVIA Limited
Responsibilities
Event Adjudication
Name
Icon (Lr) Limited
Responsibilities
ePRO & Cognitive debrief translations
Name
Marken Limited
Responsibilities
Direct to Patient

Third parties

  • {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"CRF Supplier","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM and RTSM Help center","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Denmark","full_name":"HCL Technologies Denmark Aps","duties_or_roles":"e-PID helpdesk","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"unknown (code 4)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging Supplier","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Somalogic Operating Co. Inc.","duties_or_roles":"Special Laboratory: Exploratory proteomics samples","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"ePRO & eDiary translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Event Adjudication","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA Supplier","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Marken Limited","duties_or_roles":"Direct to Patient","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"Special Laboratory: Antibody Analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Special Laboratory: PK, Biomarkers and antibodies","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"ePRO & Cognitive debrief translations","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
CagriSema (combination of cagrilintide and semaglutide)
Active Substance
cagrilintide (NNC0174-0833) | semaglutide (NNC0113-0217)
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous (s.c.)
Route
Subcutaneous
Frequency
Once-weekly
Investigational Product Name
Cagrilintide (NN9838 / NNC0174-0833)
Active Substance
cagrilintide (NNC0174-0833)
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous (s.c.)
Route
Subcutaneous
Investigational Product Name
Semaglutide (NNC0113-0217)
Active Substance
semaglutide (NNC0113-0217)
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous (s.c.)
Route
Subcutaneous
Investigational Product Name
Placebo
Modality
Other
Combination Treatment
Yes

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