Clinical trial • Phase III • Endocrinology

ZENAGAMTIDE for Obesity

Phase III trial of ZENAGAMTIDE for Obesity. Randomised, placebo-controlled. 275 participants.

Overview

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

Key dates

Initial CTIS Submission Date
12-01-2026
First CTIS Authorization Date
27-04-2026

Trial design

Randomised, placebo-controlled Phase III trial in Belgium, Bulgaria, Denmark and others.

Randomised
Yes
Comparator
Placebo
Target Sample Size
275
Trial Duration For Participant
777

Eligibility

Recruits 275 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants must be aged ≥ 18 years and provide informed consent; no assent/parental consent procedures for minors are specified in the record..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Participants must be aged ≥ 18 years and provide informed consent; no assent/parental consent procedures for minors are specified in the record.

Inclusion criteria

  • {"criterion_text":"- Male or female (sex at birth)."}
  • {"criterion_text":"- Age between 18 CCI years CCI at the time of signing informed consent."}
  • {"criterion_text":"- Body Mass Index (BMI) ≥ CCI kg/m2."}
  • {"criterion_text":"- CCI"}

Exclusion criteria

  • {"criterion_text":"- Glycated haemoglobin (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 as declared by the participant or reported in the medical records."}
  • {"criterion_text":"- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues within CCI before screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Relative change in body weight","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Relative change in body weight","definition_or_measurement_approach":""}
  • {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
  • {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
  • {"endpoint_text":"- CCI","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-36v2® Health Survey Acute (SF-36v2 Acute) Physical functioning score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in body weight","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in body mass index (BMI)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in glycated haemoglobin (HbA1c)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in fasting plasma glucose (FPG)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in fasting insulin","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in diastolic blood pressure (DBP)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in high-sensitivity C-reactive protein (hsCRP)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in IWQOL-Lite-CT: Physical composite score Psychosocial composite score Total score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment
True, patient association (unnamed)
Digital Remote Recruitment
True, recruitment documents include landing pages, web advertisements, digital reels/carrousel adverts and online promotional text (country-specific digital materials present).
Planned Sample Size
275
Recruitment Window Months
26
Consent Approach
Informed consent is obtained from each participant (participants must be ≥ 18 years). Subject information and informed consent forms are provided in country/language-specific versions (examples include English, French, Dutch, German, Bulgarian, Spanish, Italian). Partner/partner-statement and home-delivery information documents are available where applicable.

Methods

  • Direct-to-patient delivery (documented sponsor duty: 'Direct to patient' via Marken Limited).
  • Printed recruitment materials and posters (country-specific recruitment-poster documents present for Belgium, Netherlands, France, Germany, Italy, Spain, Bulgaria, Denmark).
  • Digital recruitment (landing pages, website advertisements, reels, carrousel adverts, promotional web content) as documented in country recruitment materials (examples: Spain, Netherlands, Belgium).
  • Patient-association targeted outreach (recruitment poster for patient association present in Spain).

Geography

Total Number Of Sites
48
Total Number Of Participants
325

Belgium

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
32
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Anima
Principal Investigator Name
Erik Buntinx
Principal Investigator Email
erik.buntinx@anima-alken.be
Contact Person Name
Erik Buntinx
Contact Person Email
erik.buntinx@anima-alken.be
Site Name
Anima
Principal Investigator Name
Erik Buntinx
Principal Investigator Email
erik.buntinx@anima-alken.be
Contact Person Name
Erik Buntinx
Contact Person Email
erik.buntinx@anima-alken.be
Site Name
Algemeen Ziekenhuis Groeninge
Principal Investigator Name
Gerd Vanhaverbeke
Principal Investigator Email
gerd.vanhaverbeke@azgroeninge.be
Contact Person Name
Gerd Vanhaverbeke
Site Name
Centre hospitalier universitaire de Liege
Principal Investigator Name
Nathalie Esser
Principal Investigator Email
Nathalie.Esser@chuliege.be
Contact Person Name
Nathalie Esser
Contact Person Email
Nathalie.Esser@chuliege.be

Bulgaria

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
32
Number Of Sites
9
Number Of Participants
45

Sites

Site Name
Alexandrovska University Hospital
Department Name
Clinic of Endocrinology and Metabolic Diseases
Principal Investigator Name
Zdravko Kamenov
Principal Investigator Email
zkamenov@hotmail.com
Contact Person Name
Zdravko Kamenov
Contact Person Email
zkamenov@hotmail.com
Site Name
Medical Center Maria Med EOOD
Department Name
Endocrinology consulting room
Principal Investigator Name
Ivona Daskalova
Principal Investigator Email
bda.congress@abv.bg
Contact Person Name
Ivona Daskalova
Contact Person Email
bda.congress@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Clinic of Endocrinology and Metabolic Diseases
Principal Investigator Name
Boyan Nonchev
Principal Investigator Email
nonchev_md@abv.bg
Contact Person Name
Boyan Nonchev
Contact Person Email
nonchev_md@abv.bg
Site Name
MBAL Med Line Clinic AD
Department Name
Department of Endocrinology and Metabolic Diseases
Principal Investigator Name
Dimitar Georgiev
Principal Investigator Email
ddime@mail.bg
Contact Person Name
Dimitar Georgiev
Contact Person Email
ddime@mail.bg
Site Name
Outpatient Clinic For Individual Practice For Specialized Medical Care Dr. Traykovska EOOD
Department Name
Endocrinology consulting room
Principal Investigator Name
Aleksandra Traykovska-Dimitrova
Principal Investigator Email
dr.trajkovska@yahoo.com
Contact Person Name
Aleksandra Traykovska-Dimitrova
Contact Person Email
dr.trajkovska@yahoo.com
Site Name
Outpatient Center For Individual Practice For Specialized Outpatient Medical Care In Endocrinology And Diseases Of The Mutual System Endo Med Consult 2020 - Dr. Alexander Botushanov
Department Name
Endocrinology consulting room
Principal Investigator Name
Nikolay Botushanov
Principal Investigator Email
nbotush@gmail.com
Contact Person Name
Nikolay Botushanov
Contact Person Email
nbotush@gmail.com
Site Name
Diagnostic Consultative Center 1 Lom EOOD
Department Name
Endocrinology consulting room
Principal Investigator Name
Vladislav Ivanov
Principal Investigator Email
vladiivanov@dir.bg
Contact Person Name
Vladislav Ivanov
Contact Person Email
vladiivanov@dir.bg
Site Name
Specialized Obstetrics And Gynecology Hospital For Active Treatment Dr. Shterev EOOD
Department Name
Department of Obstetrics and Gynecology
Principal Investigator Name
Vesselina Yanachkova
Principal Investigator Email
v_ess@abv.bg
Contact Person Name
Vesselina Yanachkova
Contact Person Email
v_ess@abv.bg

Denmark

Earliest CTIS Part Ii Submission Date
21-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
7
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Region Sjaelland
Principal Investigator Name
Jesper Krogh
Principal Investigator Email
jekrog@regionsjaelland.dk
Contact Person Name
Jesper Krogh
Contact Person Email
jekrog@regionsjaelland.dk
Site Name
Sanos A/S
Principal Investigator Name
David Overgaard
Principal Investigator Email
dlo@sanosclinic.com
Contact Person Name
David Overgaard
Contact Person Email
dlo@sanosclinic.com
Site Name
Esbjerg Og Grindsted Sygehus
Principal Investigator Name
Claus Juhl
Principal Investigator Email
Claus.Bogh.Juhl@rsyd.dk
Contact Person Name
Claus Juhl
Contact Person Email
Claus.Bogh.Juhl@rsyd.dk

France

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
32
Number Of Sites
5
Number Of Participants
40

Sites

Site Name
Groupe Sos Sante
Principal Investigator Name
Julien Paccini
Principal Investigator Email
julien.paccini@groupe-sos.org
Contact Person Name
Julien Paccini
Contact Person Email
julien.paccini@groupe-sos.org
Site Name
Centre Hospitalier Universitaire De Poitiers
Principal Investigator Name
Hélena MOSBAH
Principal Investigator Email
Helena.MOSBAH@chu-poitiers.fr
Contact Person Name
Hélena MOSBAH
Contact Person Email
Helena.MOSBAH@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Lille
Principal Investigator Name
Hélène Verkindt
Principal Investigator Email
helene.verkindt@chu-lille.fr
Contact Person Name
Hélène Verkindt
Contact Person Email
helene.verkindt@chu-lille.fr
Site Name
University Hospital Of Clermont-Ferrand
Principal Investigator Name
Yves Boirie
Principal Investigator Email
yboirie@chu-clermontferrand.fr
Contact Person Name
Yves Boirie
Contact Person Email
yboirie@chu-clermontferrand.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Principal Investigator Name
Anne-Laure BOREL
Principal Investigator Email
alborel@chu-grenoble.fr
Contact Person Name
Anne-Laure BOREL
Contact Person Email
alborel@chu-grenoble.fr

Germany

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
34
Number Of Sites
7
Number Of Participants
45

Sites

Site Name
Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet
Principal Investigator Name
Thomas Segiet
Principal Investigator Email
segiet.thomas@web.de
Contact Person Name
Thomas Segiet
Contact Person Email
segiet.thomas@web.de
Site Name
Institut fuer Diabetesforschung Muenster GmbH
Principal Investigator Name
Ludger Rose
Principal Investigator Email
l.rose@diabetes-muenster.de
Contact Person Name
Ludger Rose
Contact Person Email
l.rose@diabetes-muenster.de
Site Name
Zentrum für klinische Studien Alexander Segner
Principal Investigator Name
Alexander Segner
Principal Investigator Email
alexander.segner@zks-igb.de
Contact Person Name
Alexander Segner
Contact Person Email
alexander.segner@zks-igb.de
Site Name
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Principal Investigator Name
Thomas Schaum
Principal Investigator Email
schaum@red-institut.de
Contact Person Name
Thomas Schaum
Contact Person Email
schaum@red-institut.de
Site Name
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Principal Investigator Name
Andreas Staudenmeyer
Principal Investigator Email
staudenmeyer@diabetes-lingen.de
Contact Person Name
Andreas Staudenmeyer
Site Name
Diabeteszentrum Hamburg West (DZHW)
Principal Investigator Name
Dominik Dahl
Principal Investigator Email
dr.dahl@dzhw.de
Contact Person Name
Dominik Dahl
Contact Person Email
dr.dahl@dzhw.de
Site Name
Eugastro GmbH
Department Name
Zentrum Sudost
Principal Investigator Name
Ingolf Schiefke
Principal Investigator Email
Ingolf.Schiefke@eugastro.de
Contact Person Name
Ingolf Schiefke
Contact Person Email
Ingolf.Schiefke@eugastro.de

Italy

Earliest CTIS Part Ii Submission Date
27-01-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
91
Number Of Sites
8
Number Of Participants
40

Sites

Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Principal Investigator Name
Mauro Zamboni
Principal Investigator Email
mauro.zamboni@univr.it
Contact Person Name
Mauro Zamboni
Contact Person Email
mauro.zamboni@univr.it
Site Name
Istituti Clinici Scientifici Maugeri S.p.A.
Principal Investigator Name
Flavia Magri
Principal Investigator Email
flavia.magri@icsmaugeri.it
Contact Person Name
Flavia Magri
Contact Person Email
flavia.magri@icsmaugeri.it
Site Name
IRCCS Ospedale Policlinico San Martino
Principal Investigator Name
Mara Boschetti
Principal Investigator Email
mara.boschetti@unige.it
Contact Person Name
Mara Boschetti
Contact Person Email
mara.boschetti@unige.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Principal Investigator Name
Uberto Pagotto
Principal Investigator Email
uberto.pagotto@unibo.it
Contact Person Name
Uberto Pagotto
Contact Person Email
uberto.pagotto@unibo.it
Site Name
University Hospital Of Ferrara
Principal Investigator Name
Maria Chiara Zatelli
Principal Investigator Email
ztlmch@unife.it
Contact Person Name
Maria Chiara Zatelli
Contact Person Email
ztlmch@unife.it
Site Name
Humanitas Mirasole S.p.A.
Principal Investigator Name
Marco Mirani
Principal Investigator Email
marco.mirani@humanitas.it
Contact Person Name
Marco Mirani
Contact Person Email
marco.mirani@humanitas.it
Site Name
Azienda Ospedaliera di Padova
Principal Investigator Name
Mirto Foletto
Principal Investigator Email
mirto.foletto@unipd.it
Contact Person Name
Mirto Foletto
Contact Person Email
mirto.foletto@unipd.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Principal Investigator Name
Manfredi Rizzo
Principal Investigator Email
manfredi.rizzo@unipa.it
Contact Person Name
Manfredi Rizzo
Contact Person Email
manfredi.rizzo@unipa.it

Spain

Earliest CTIS Part Ii Submission Date
25-02-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
68
Number Of Sites
7
Number Of Participants
45

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Principal Investigator Name
Virginia Bellido Castañeda
Contact Person Name
Virginia Bellido Castañeda
Site Name
Hospital Clinico San Carlos
Principal Investigator Name
Miguel Rubio
Principal Investigator Email
miguelangel.rubio@salud.madrid.org
Contact Person Name
Miguel Rubio
Site Name
Hospital Universitario Virgen De La Victoria
Principal Investigator Name
Francisco Tinahones
Principal Investigator Email
ensayosclinicosendocrino@ibima.eu
Contact Person Name
Francisco Tinahones
Site Name
Hospital Universitario Quironsalud Madrid
Principal Investigator Name
Esteban Jodar
Principal Investigator Email
esteban.jodar@quironsalud.es
Contact Person Name
Esteban Jodar
Contact Person Email
esteban.jodar@quironsalud.es
Site Name
Hospital Clinic De Barcelona
Principal Investigator Name
Ana de Hollanda
Principal Investigator Email
endotrials@clinic.cat
Contact Person Name
Ana de Hollanda
Contact Person Email
endotrials@clinic.cat
Site Name
Centro Periferico De Especialidades Bola Azul
Principal Investigator Name
Pedro Mezquita Raya
Principal Investigator Email
pmr.hut@gmail.com
Contact Person Name
Pedro Mezquita Raya
Contact Person Email
pmr.hut@gmail.com
Site Name
Area De Salud De Leon Y El Bierzo
Principal Investigator Name
María Ballesteros Pomar
Principal Investigator Email
dballesteros@saludcastillayleon.es
Contact Person Name
María Ballesteros Pomar

Netherlands

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
12
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
Rijnstate Ziekenhuis Stichting
Principal Investigator Name
Arianne van Bon
Principal Investigator Email
ACvanBon@rijnstate.nl
Contact Person Name
Arianne van Bon
Contact Person Email
ACvanBon@rijnstate.nl
Site Name
Meander Medisch Centrum
Principal Investigator Name
Lioe-Ting Dijkhorst - Oei
Principal Investigator Email
L.Dijkhorst-oei@meandermc.nl
Contact Person Name
Lioe-Ting Dijkhorst - Oei
Contact Person Email
L.Dijkhorst-oei@meandermc.nl
Site Name
EB FlevoResearch B.V.
Principal Investigator Name
Mazin AlHakim
Principal Investigator Email
M.Alhakim@flevoresearch.com
Contact Person Name
Mazin AlHakim
Contact Person Email
M.Alhakim@flevoresearch.com
Site Name
PreCare Trial & Recruitment B.V.
Principal Investigator Name
V.E.K.M. Van de Walle
Principal Investigator Email
vivienne.vandewalle@ptr.nu
Contact Person Name
V.E.K.M. Van de Walle
Contact Person Email
vivienne.vandewalle@ptr.nu
Site Name
Brain Research Center Den Bosch B.V.
Principal Investigator Name
V.E.K.M. Van de Walle
Principal Investigator Email
v.vandewalle@progressresearch.com
Contact Person Name
V.E.K.M. Van de Walle

Sponsor

Primary sponsor

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

Contract research organisations

Name
Marken Limited
Responsibilities
Direct to patient
Name
Icon Clinical Research Limited
Responsibilities
Central Laboratory
Name
Veeva Systems Inc.
Responsibilities
CRF supplier. Global Safety Database supplier.
Name
Roche Diabetes Care Inc.
Responsibilities
Blood Glucose Meter
Name
4G Clinical B.V.
Responsibilities
RTSM/IWRS supplier
Name
Celerion Switzerland AG
Responsibilities
Laboratory analysis
Name
Iqvia Biotech Limited
Responsibilities
eCOA

Third parties

  • {"country":"United Kingdom","full_name":"Marken Limited","duties_or_roles":"Direct to patient","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"CRF supplier. Global Safety Database supplier.","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Roche Diabetes Care Inc.","duties_or_roles":"Blood Glucose Meter","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM/IWRS supplier","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Laboratory analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
NNC0487-0111 B 10141
Active Substance
ZENAGAMTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
1
Frequency
once weekly
Investigational Product Name
NNC0487-0111 B 10144
Active Substance
ZENAGAMTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
1
Frequency
once weekly
Investigational Product Name
NNC0487-0111 B 10142
Active Substance
ZENAGAMTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
1
Frequency
once weekly
Investigational Product Name
NNC0487-0111 B 10146
Active Substance
ZENAGAMTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
1
Frequency
once weekly
Investigational Product Name
NNC0487-0111 B 10143
Active Substance
ZENAGAMTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
1
Frequency
once weekly
Investigational Product Name
NNC0487-0111 B 10145
Active Substance
ZENAGAMTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
1
Frequency
once weekly
Investigational Product Name
Placebo
Modality
Other

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