Clinical trial • Phase III • Endocrinology
CAGRILINTIDE for Obesity | Type 2 diabetes
Phase III trial of CAGRILINTIDE for Obesity | Type 2 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Obesity | Type 2 diabetes
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 09-01-2026
- First CTIS Authorization Date
- 28-04-2026
Trial design
Randomised, semaglutide 2.4 mg subcutaneous once weekly; placebo (placebo + placebo) as comparator arm-controlled Phase III trial in Austria, Belgium, Bulgaria and others.
- Randomised
- Yes
- Comparator
- semaglutide 2.4 mg subcutaneous once weekly; Placebo (Placebo + Placebo) as comparator arm
- Target Sample Size
- 303
- Trial Duration For Participant
- 476
Eligibility
Recruits 303 paediatric patients.
- Vulnerable Population
- The trial enrols children and adolescents (aged 8 to <18 years). Consent and assent procedures are age-appropriate: informed consent must be obtained from the parent(s) or legally acceptable representative (LAR) and child assent obtained as appropriate before any study-related activities. The protocol provides child assent and parent/LAR informed consent forms (age-specific: e.g., child forms for 8-11, 12-17, and parent/LAR forms) and country-specific subject information/consent documents in local languages as per local requirements.
Inclusion criteria
- {"criterion_text":"- Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, 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. a. The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements) b. The child must sign and date the Child Assent Form or provide oral assent (according to local requirements).\n- Male or female.\n- Aged 8 to <18 years at the time of signing the informed consent.\n- Body mass index (BMI), at screening, corresponding to: a. ≥95th percentilea for children aged 8 to <12 years (Tanner stage 1-5) b. ≥95th percentilea or ≥85th percentilea with the presence of at least one obesity-related complication including, but not limited to, type 2 diabetes (T2D), hypertension, dyslipidaemia or obstructive sleep apnoea for adolescents aged 12 to <18 years (Tanner stage 2-5).\n- Laboratory parameters, as measured by the central lab at screening, within normal sex- and age-specific ranges of total calcium, phosphate, alkaline phosphatase, parathyroid hormone.\n- History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months.\n- Body weight >45 kg at screening.\n- HbA1c ≤10.0% (86 mmol/mol) as measured by central laboratory at screening.\n- Treatment with lifestyle intervention or treatment with metformin according to local label. Treatment with metformin should be stable (same dose and dosing frequency) for at least 56 days before screening."}
Exclusion criteria
- {"criterion_text":"- Treatment with any medication prescribed for obesity or weight management within 90 days before screening.\n- Recurrent severe hypoglycaemic episodes within 1 year before screening, as judged by the investigator.\n- Positive insulinoma associated protein-2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.\n- Treatment with any medication for the indication of diabetes other than those stated in the inclusion criteria within 90 days before screening.\n- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n- Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: Liposuction and/or abdominoplasty, if performed >1 year before screening. Adjustable gastric banding, if the band has been removed >1 year before screening. Intragastric balloon, if the balloon has been removed >1 year before screening. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year before screening.\n- Uncontrolled thyroid disease.\n- Endocrine, hypothalamic, or syndromic obesity.\n- A self-reported (or by parent(s)/LAR, where applicable) change in body weight >5% within 90 days before screening irrespective of medical records.\n- Type 1 diabetes or monogenic diabetes.\n- HbA1c ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.\n- Treatment with glucose -lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening.\n- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire, question 8."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Relative change in body mass index (BMI). Baseline (week 0) to end of treatment (week 68). Unit: %.","definition_or_measurement_approach":"Percent relative change in BMI from baseline (week 0) to end of treatment (week 68); unit: percent (%)."}
Secondary endpoints
- {"endpoint_text":"- Relative change in body weight. Baseline (week 0) to end of treatment (week 68). Unit: %.","definition_or_measurement_approach":"Percent relative change in body weight from baseline (week 0) to week 68; unit: percent (%)."}
- {"endpoint_text":"- Change in BMI Standard Deviation Score (SDS). Baseline (week 0) to end of treatment (week 68). Unit: SDS score","definition_or_measurement_approach":"Change in BMI standard deviation score (SDS) measured from baseline (week 0) to week 68; unit: SDS score."}
- {"endpoint_text":"- Relative change in BMI. Baseline (week 0) to end of treatment (week 68). Unit: %.","definition_or_measurement_approach":"Percent relative change in BMI from baseline (week 0) to week 68; unit: percent (%)."}
- {"endpoint_text":"- Relative change in body weight. Baseline (week 0) to end of treatment (week 68). Unit: %.","definition_or_measurement_approach":"Percent relative change in body weight from baseline (week 0) to week 68; unit: percent (%)."}
- {"endpoint_text":"- Change in BMI Standard Deviation Score (SDS). Baseline (week 0) to end of treatment (week 68). Unit: SDS score.","definition_or_measurement_approach":"Change in BMI SDS from baseline (week 0) to week 68; unit: SDS score."}
- {"endpoint_text":"- Reduction in weight category. Baseline (week 0) to end of treatment (week 68). Unit: count of participant.","definition_or_measurement_approach":"Change in categorical weight classification from baseline (week 0) to week 68, reported as counts of participants who reduce weight category."}
- {"endpoint_text":"- Reduction in weight category. Baseline (week 0) to end of treatment (week 68). Unit: count of participant.","definition_or_measurement_approach":"Change in categorical weight classification from baseline (week 0) to week 68, reported as counts of participants who reduce weight category."}
Recruitment
- Planned Sample Size
- 303
- Recruitment Window Months
- 88
- Consent Approach
- Parent(s) or legally acceptable representative (LAR) must provide written informed consent and the child must provide assent appropriate to age (child assent form signature or oral assent per local requirements). Age-specific participant information and consent/assent documents are provided (examples in the dossier: child forms for ages 8-11, 12-17, adolescent forms, parent/LAR forms, and future-research/genetic research forms). Documents are prepared for country-specific use (multiple local languages available as indicated by country-specific subject information and consent form documents).
Geography
- Total Number Of Sites
- 38
- Total Number Of Participants
- 157
Austria
- Earliest CTIS Part Ii Submission Date
- 20-04-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 10
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
- Department Name
- Universitätsklinik für Kinder und Jugendheilkunde Haus E
- Principal Investigator Name
- Daniel Weghuber
- Principal Investigator Email
- d.weghuber@salk.at
- Contact Person Name
- Daniel Weghuber
- Contact Person Email
- d.weghuber@salk.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Kinder- und Jugendheilkunde
- Principal Investigator Name
- Daniela Karall
- Principal Investigator Email
- daniela.karall@i-med.ac.at
- Contact Person Name
- Daniela Karall
- Contact Person Email
- daniela.karall@i-med.ac.at
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-04-2026
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Universitair Ziekenhuis Antwerpen
- Principal Investigator Name
- Kim Van Hoorenbeeck
- Principal Investigator Email
- kim.vanhoorenbeeck@uza.be
- Contact Person Name
- Kim Van Hoorenbeeck
- Contact Person Email
- kim.vanhoorenbeeck@uza.be
- Site Name
- UZ Brussel
- Principal Investigator Name
- Inge Gies
- Principal Investigator Email
- inge.gies@uzbrussel.be
- Contact Person Name
- Inge Gies
- Contact Person Email
- inge.gies@uzbrussel.be
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 06-04-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev
- Department Name
- Clinic of pediatric endocrinology and metabolic diseases
- Principal Investigator Name
- Margarita Archinkova
- Principal Investigator Email
- archinkova@yahoo.com
- Contact Person Name
- Margarita Archinkova
- Contact Person Email
- archinkova@yahoo.com
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of Pediatric
- Principal Investigator Name
- Tsvetelina Tsvetanova
- Principal Investigator Email
- tsetsi_tsetsi@yahoo.co.uk
- Contact Person Name
- Tsvetelina Tsvetanova
- Contact Person Email
- tsetsi_tsetsi@yahoo.co.uk
- Site Name
- Children's Health Medical Center EOOD
- Department Name
- Consulting room 14
- Principal Investigator Name
- Elena Vuchkova-Lukanova
- Principal Investigator Email
- elena_vu4kova@abv.bg
- Contact Person Name
- Elena Vuchkova-Lukanova
- Contact Person Email
- elena_vu4kova@abv.bg
- Site Name
- MBAL Sveta Marina EAD
- Department Name
- First pediatric clinic, Pediatric department for intensive treatment
- Principal Investigator Name
- Violeta Iotova
- Principal Investigator Email
- iotova_v@abv.bg
- Contact Person Name
- Violeta Iotova
- Contact Person Email
- iotova_v@abv.bg
Croatia
- Earliest CTIS Part Ii Submission Date
- 02-04-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 32
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Clinical Hospital Centre Rijeka
- Principal Investigator Name
- Srecko Severinski
- Principal Investigator Email
- sreckoseverinski@yahoo.com
- Contact Person Name
- Srecko Severinski
- Contact Person Email
- sreckoseverinski@yahoo.com
- Site Name
- Klinicki bolnicki centar Sestre milosrdnice
- Principal Investigator Name
- Lavinia La Grasta Sabolic
- Principal Investigator Email
- young.kbcsm@gmail.com
- Contact Person Name
- Lavinia La Grasta Sabolic
- Contact Person Email
- young.kbcsm@gmail.com
- Site Name
- Klinika Za Djecje Bolesti Zagreb
- Principal Investigator Name
- Anita Spehar Uroic
- Principal Investigator Email
- anspehar@gmail.com
- Contact Person Name
- Anita Spehar Uroic
- Contact Person Email
- anspehar@gmail.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 02-04-2026
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Holbaek Sygehus
- Principal Investigator Name
- Jens-Christian Holm
- Principal Investigator Email
- jhom@regionsjaelland.dk
- Contact Person Name
- Jens-Christian Holm
- Contact Person Email
- jhom@regionsjaelland.dk
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-03-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 62
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Eszak-Budai Szent Janos Centrumkorhaz
- Department Name
- Észak-Közép-budai Centrum, Szent János Kórház és Szakrendel
- Principal Investigator Name
- Borbála Tobisch
- Principal Investigator Email
- study@janoskorhaz.hu
- Contact Person Name
- Borbála Tobisch
- Contact Person Email
- study@janoskorhaz.hu
- Site Name
- University Of Szeged
- Department Name
- Szegedi Tudományegyetem Gyermekgyógyászati Klinika
- Principal Investigator Name
- Ágnes Maróti
- Principal Investigator Email
- marotiagi79@gmail.com
- Contact Person Name
- Ágnes Maróti
- Contact Person Email
- marotiagi79@gmail.com
- Site Name
- Semmelweis University
- Department Name
- Gyermekgyógyászati Klinika - Bókay utcai részleg
- Principal Investigator Name
- Andrea Luczay
- Principal Investigator Email
- luczay.andrea@semmelweis.hu
- Contact Person Name
- Andrea Luczay
- Contact Person Email
- luczay.andrea@semmelweis.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 27-03-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 33
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Principal Investigator Name
- Claudia Giavoli
- Principal Investigator Email
- claudia.giavoli@policlinico.mi.it
- Contact Person Name
- Claudia Giavoli
- Contact Person Email
- claudia.giavoli@policlinico.mi.it
- Site Name
- Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
- Principal Investigator Name
- Gianluca Tornese
- Principal Investigator Email
- gianluca.tornese@burlo.trieste.it
- Contact Person Name
- Gianluca Tornese
- Contact Person Email
- gianluca.tornese@burlo.trieste.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Principal Investigator Name
- Ivana Rabbone
- Principal Investigator Email
- ivana.rabbone@uniupo.it
- Contact Person Name
- Ivana Rabbone
- Contact Person Email
- ivana.rabbone@uniupo.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Principal Investigator Name
- Claudio Maffeis
- Principal Investigator Email
- claudio.maffeis@univr.it
- Contact Person Name
- Claudio Maffeis
- Contact Person Email
- claudio.maffeis@univr.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 24-02-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 65
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Principal Investigator Name
- Ana Luísa Leite
- Principal Investigator Email
- ana.leite@ulsge.min-saude.pt
- Contact Person Name
- Ana Luísa Leite
- Contact Person Email
- ana.leite@ulsge.min-saude.pt
- Site Name
- Hospital CUF Porto S.A.
- Principal Investigator Name
- Carla Rêgo
- Principal Investigator Email
- carla.c.rego@cuf.pt
- Contact Person Name
- Carla Rêgo
- Contact Person Email
- carla.c.rego@cuf.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Principal Investigator Name
- Helena Mansilha
- Principal Investigator Email
- helenamansilha@chporto.min-saude.pt
- Contact Person Name
- Helena Mansilha
- Contact Person Email
- helenamansilha@chporto.min-saude.pt
Romania
- Earliest CTIS Part Ii Submission Date
- 17-04-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 17
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Kilostop Junior S.R.L.
- Principal Investigator Name
- Steluta Boroghina
- Principal Investigator Email
- steluta_boroghina@yahoo.com
- Contact Person Name
- Steluta Boroghina
- Contact Person Email
- steluta_boroghina@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
- Department Name
- Pediatrie II BEGA
- Principal Investigator Name
- Iulian Velea
- Principal Investigator Email
- ivelea56@yahoo.com
- Contact Person Name
- Iulian Velea
- Contact Person Email
- ivelea56@yahoo.com
- Site Name
- Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
- Department Name
- Pediatrie II
- Principal Investigator Name
- Carmen Novac
- Principal Investigator Email
- irimaria3@gmail.com
- Contact Person Name
- Carmen Novac
- Contact Person Email
- irimaria3@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 25-03-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 40
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Principal Investigator Name
- Marta Ramón-Krauel
- Principal Investigator Email
- marta.ramon@sjd.es
- Contact Person Name
- Marta Ramón-Krauel
- Contact Person Email
- marta.ramon@sjd.es
- Site Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Principal Investigator Name
- Eduard Mogas Viñals
- Principal Investigator Email
- eduard.mogas@vallhebron.cat
- Contact Person Name
- Eduard Mogas Viñals
- Contact Person Email
- eduard.mogas@vallhebron.cat
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Principal Investigator Name
- Pedro Pablo García Luna
- Principal Investigator Email
- garcialunapp@yahoo.es
- Contact Person Name
- Pedro Pablo García Luna
- Contact Person Email
- garcialunapp@yahoo.es
Sweden
- Earliest CTIS Part Ii Submission Date
- 03-04-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Region Vaesterbotten
- Principal Investigator Name
- Elena Lundberg
- Principal Investigator Email
- elena.lundberg@umu.se
- Contact Person Name
- Elena Lundberg
- Contact Person Email
- elena.lundberg@umu.se
- Site Name
- Uppsala University Hospital
- Principal Investigator Name
- Anders Forslund
- Principal Investigator Email
- anders.forslund@akademiska.se
- Contact Person Name
- Anders Forslund
- Contact Person Email
- anders.forslund@akademiska.se
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-04-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Jeroen Bosch Ziekenhuis Stichting
- Principal Investigator Name
- Edgar van Mil
- Principal Investigator Email
- researchKIND@jbz.nl
- Contact Person Name
- Edgar van Mil
- Contact Person Email
- researchKIND@jbz.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 31-03-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 30
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny W Opolu
- Department Name
- Oddział Pediatrii z Pododzialem Gastroenterologii i Diabetologii Dzieciecej
- Principal Investigator Name
- Agata Chobot
- Principal Investigator Email
- agata.chobot@usk.opole.pl
- Contact Person Name
- Agata Chobot
- Contact Person Email
- agata.chobot@usk.opole.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Klinika Pediatrii, Oddział Endokrynologii Dziecięcej
- Principal Investigator Name
- Agnieszka Zachurzok
- Principal Investigator Email
- azachurzok@sum.edu.pl
- Contact Person Name
- Agnieszka Zachurzok
- Contact Person Email
- azachurzok@sum.edu.pl
- Site Name
- Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej Im. Dzieci Warszawy W Dziekanowie Lesnym
- Department Name
- Kliniczny Oddział Pediatrii
- Principal Investigator Name
- Piotr Hartmann
- Principal Investigator Email
- piotr.hartmann@szpitaldziekanow.pl
- Contact Person Name
- Piotr Hartmann
- Contact Person Email
- piotr.hartmann@szpitaldziekanow.pl
- Site Name
- Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
- Department Name
- II Klinika Pediatrii, Endokrynologii i Diabetologii Dziecięcej
- Principal Investigator Name
- Artur Mazur
- Principal Investigator Email
- endokrynologia.dzieci@szpital2.rzeszow.pl
- Contact Person Name
- Artur Mazur
- Contact Person Email
- endokrynologia.dzieci@szpital2.rzeszow.pl
Slovakia
- Earliest CTIS Part Ii Submission Date
- 31-03-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 29
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Detska Fakultna Nemocnica Kosice
- Department Name
- Ambulancia pediatrickej endokrinologie a diabetologie a poruch latkovej premeny a vyzivy
- Principal Investigator Name
- Adriana Dankovcikova
- Principal Investigator Email
- adriana.dankovcikova@dfnkosice.sk
- Contact Person Name
- Adriana Dankovcikova
- Contact Person Email
- adriana.dankovcikova@dfnkosice.sk
- Site Name
- Narodny Endokrinologicky A Diabetologicky Ustav
- Department Name
- Detske oddelenie
- Principal Investigator Name
- Miriam Kuricova
- Principal Investigator Email
- mimakuric237@gmail.com
- Contact Person Name
- Miriam Kuricova
- Contact Person Email
- mimakuric237@gmail.com
- Site Name
- Narodny Ustav Detskych Chorob
- Department Name
- Endokrinologicka ambulancia detskej kliniky LFUK
- Principal Investigator Name
- Juraj Stanik
- Principal Investigator Email
- jurajstanik@hotmail.com
- Contact Person Name
- Juraj Stanik
- Contact Person Email
- jurajstanik@hotmail.com
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Central Laboratory
- Name
- Celerion Switzerland AG
- Responsibilities
- Special Laboratory PK, biomarkers and antibodies
- Name
- Wuxi Apptec (Shanghai) Co. Ltd.
- Responsibilities
- Special Laboratory (antibody analysis China)
- Name
- Signant Health Global Solutions Limited
- Responsibilities
- eCOA
- Name
- 4G Clinical B.V.
- Responsibilities
- RTSM supplier
- Name
- Veeva Systems Inc.
- Responsibilities
- CRF supplier
Third parties
- {"country":"China","full_name":"Wuxi Apptec (Shanghai) Co. Ltd.","duties_or_roles":"Special Laboratory (antibody analysis China)","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"Global Safety Database supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging: DXA, X-Ray, MRI and MRE","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Synexa Life Sciences BV","duties_or_roles":"Special Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"External independent statistician for DMC","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"CRF supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Roche Diabetes Care Inc.","duties_or_roles":"BG Meters","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Special Laboratory PK, biomarkers and antibodies","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- cagrilintide
- Active Substance
- CAGRILINTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Starting Dose
- 2.4 mg
- Frequency
- once weekly
- Maximum Dose
- 2.4 mg
- Investigational Product Name
- semaglutide
- Active Substance
- SEMAGLUTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Starting Dose
- 2.4 mg
- Frequency
- once weekly
- Maximum Dose
- 2.4 mg
- Investigational Product Name
- cagrilintide semaglutide
- Active Substance
- CAGRILINTIDE, SEMAGLUTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Starting Dose
- Cagrilintide 2.4 mg / Semaglutide 2.4 mg
- Frequency
- once weekly
- Maximum Dose
- Cagrilintide 2.4 mg / Semaglutide 2.4 mg
- Investigational Product Name
- Placebo + Placebo
- Modality
- Other
- Combination Treatment
- Yes
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