Clinical trial • Phase III • Endocrinology
ZENAGAMTIDE for Obesity
Phase III trial of ZENAGAMTIDE for Obesity. Randomised, placebo-controlled. 850 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
- 04-05-2026
Trial design
Randomised, placebo-controlled Phase III trial in Belgium, France, Germany and others.
- Randomised
- Yes
- Comparator
- Placebo
- Target Sample Size
- 850
Eligibility
Recruits 850 No vulnerable population selected; participants are adults (Age 18 years and older). Informed consent obtained from adult participants; partner information/consent documents are provided (adult/partner ICFs available)..
- Vulnerable Population
- No vulnerable population selected; participants are adults (Age 18 years and older). Informed consent obtained from adult participants; partner information/consent documents are provided (adult/partner ICFs available).
Inclusion criteria
- {"criterion_text":"- 1. Male or female (sex at birth).\n- 2. Age 18CCI years CCI at the time of signing the informed consent.\n- 3. Body Mass Index (BMI) CCI kg/m2 .\n- 4. CCI"}
Exclusion criteria
- {"criterion_text":"- 1. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.\n- 2. History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.\n- 3. 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":"- CCI\n- CCI\n- CCI\n- Change in waist circumference\n- Change in systolic blood pressure (SBP)\n- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score\n- CCI\n- Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning scorea\n- CCI\n- Change in body weight\n- Change in body mass index (BMI)\n- CCI\n- Change in IWQOL-Lite-CT Physical composite score Psychosocial composite score Total score\n- CCI\n- CCI\n- CCI\n- Change in glycated haemoglobin (HbA1c)\n- Change in fasting plasma glucose (FPG)\n- Change in fasting insulin\n- Change in diastolic blood pressure (DBP)\n- 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\n- Change in high-sensitivity C-reactive protein (hsCRP)\n- CCI\n- CCI\n- Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation\n- Extension phase secondary endpoints are as follows: Relative change in body weight\n- CCI\n- Change in body weight\n- Change in body mass index (BMI)\n- CCI\n- Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score\n- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT): Physical composite score Physical functioning score Psychosocial composite score Total score\n- CCI\n- CCI\n- CCI\n- CCI\n- Change in waist circumference\n- Change in systolic blood pressure (SBP)\n- Change in glycated haemoglobin (HbA1c)\n- Change in fasting plasma glucose (FPG)\n- Change in fasting insulin\n- Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglyceride\n- Change in high-sensitivity C-reactive protein (hsCRP)\n- CCI\n- CCI\n- Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation","definition_or_measurement_approach":""}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 850
- Recruitment Window Months
- 39
- Consent Approach
- Informed consent obtained from adult participants (participants aged 18 years and older). Subject information and informed consent forms (ICFs) are available in multiple languages and country-specific versions (examples in Dutch, French, English, German, Danish are present among uploaded l1/l2 documents). Partner information/partner ICFs are provided where applicable. No paediatric assent procedures indicated.
Methods
- Recruitment via landing page (TrialTree) / website text (country-specific landing pages and website texts referenced in recruitment materials).
- Social media texts / social media recruitment (titles reference social-media-texts).
- Recruitment posters and promotional materials (posters in Dutch, French, German, Danish as per recruitment-material titles).
- Recruitment brochures and site-specific recruitment plans (site Meclinas materials).
- Letters to participants (country-specific, e.g. Danish letter-to-participants document).
- Direct-to-Patient (DTP) distribution (third party Marken Limited duties indicate Direct to Patient).
- Home delivery information referenced in subject information materials (France document l1_fr...-piic-home-delivery).
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 270
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-04-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 31
- Number Of Sites
- 6
- Number Of Participants
- 60
Sites
- Site Name
- Algemeen Ziekenhuis Delta
- Contact Person Name
- Francis Duyck
- Contact Person Email
- francis.duyck@azdelta.be
- Site Name
- Hopital Erasme
- Contact Person Name
- Laurent Crenier
- Contact Person Email
- laurent.crenier@hubruxelles.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Department of Endocrinology, Diabetology and Metabolic diseases
- Contact Person Name
- Eveline Dirinck
- Contact Person Email
- eveline.dirinck@uza.be
- Site Name
- Meclinas
- Contact Person Name
- Julie Casaer
- Contact Person Email
- julie.casaer@meclinas.com
- Site Name
- Universitair Ziekenhuis Gent
- Contact Person Name
- Imke Matthys
- Contact Person Email
- imke.matthys@uzgent.be
- Site Name
- UZ Leuven
- Contact Person Name
- Roman Vangoitsenhoven
- Contact Person Email
- roman.vangoitsenhoven@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 05-02-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 90
- Number Of Sites
- 5
- Number Of Participants
- 80
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
- Centre Hospitalier Universitaire De Toulouse
- Contact Person Name
- Emilie Montastier
- Contact Person Email
- montastier.e@chu-toulouse.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Contact Person Name
- Sebastien CZERNICHOW
- Contact Person Email
- sebastien.czernichow@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Contact Person Name
- Emmanuel DISSE
- Contact Person Email
- emmanuel.disse@chu-lyon.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 65
- Number Of Sites
- 7
- Number Of Participants
- 60
Sites
- Site Name
- Smo Md GmbH
- Department Name
- Zentrum für klinische Studien Magdeburg
- Contact Person Name
- Falk Schlichthaar
- Contact Person Email
- fsc@smo-md.de
- Site Name
- Institut für Diabetesforschung Osnabrück
- Contact Person Name
- Markus Graf
- Contact Person Email
- mgraf@dzos.de
- Site Name
- MVZ im Altstadt-Carree Fulda GmbH
- Contact Person Name
- Jörg Simon
- Contact Person Email
- Simon.Fulda@t-online.de
- Site Name
- Zentrum fuer klinische Studien Suedbrandenburg GmbH
- Contact Person Name
- Andreas Hagenow
- Contact Person Email
- a.hagenow@zks-sbb.com
- Site Name
- Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
- Contact Person Name
- Susanne Reger-Tan
- Contact Person Email
- sreger-tan@hdz-nrw.de
- Site Name
- KliFoCenter GmbH
- Department Name
- Forschungszentrum Ruhr
- Contact Person Name
- Gerd Kahrmann
- Contact Person Email
- kahrmann@forschungszentrum-ruhr.de
- Site Name
- Additional site (organisation Smo Md GmbH entry repeated?)
Denmark
- Earliest CTIS Part Ii Submission Date
- 22-04-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 16
- Number Of Sites
- 5
- Number Of Participants
- 70
Sites
- Site Name
- Gentofte Hospital
- Contact Person Name
- Asger Lund
- Contact Person Email
- Asger.Lund.01@regionh.dk
- Site Name
- Region Hovedstaden (Kettegaard Alle 36)
- Contact Person Name
- Carsten Dirksen
- Contact Person Email
- carsten.dirksen@regionh.dk
- Site Name
- Sanos A/S (Borgergade 39)
- Contact Person Name
- Cecilie Rovsing
- Contact Person Email
- cec@sanosclinic.com
- Site Name
- Region Hovedstaden (Dyrehavevej 29)
- Contact Person Name
- Ulrik Pedersen-Bjergaard
- Contact Person Email
- ulrik.pedersen-bjergaard@regionh.dk
- Site Name
- Sanos A/S (Boulevarden 19g)
- Contact Person Name
- David Overgaard
- Contact Person Email
- dlo@sanosclinic.com
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Ambulatory Blood Pressure Monitoring; eCOA; supplier support
- Name
- Icon Clinical Research Limited
- Responsibilities
- Imaging; Central Laboratory coordination
- Name
- Celerion Switzerland AG
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Ambulatory Blood Pressure Monitoring; eCOA; supplier queries; studyhubtechsupport@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Imaging; Central Laboratory (LabSiteHelp@iconplc.com)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Roche Diabetes Care Inc.","duties_or_roles":"Blood Glucose Meter (accuchekdelivers@roche.com)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited (supplier.queries)","duties_or_roles":"eCOA (supplier.queries@iqvia.com)","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM/IWRS supplier and RTSM/IWRS helpdesk","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited (LabSiteHelp)","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Marken Limited","duties_or_roles":"Direct to Patient (PM.NovoNordisk.DTP@marken.com)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Colorado Prevention Center","duties_or_roles":"Performance Tests: Timed Up and Go (TUG) and Sit to Stand","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"CRF supplier and Global Safety Database supplier","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- 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 10145
- 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 (duplicate listing in Part I/Group)
- 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 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 10141
- 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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