NCT07564414ClinicalTrials.gov

A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Phase 32 500 participants recherchés303 sites19 pays

Catégories

Endocrinien et métabolique100%

Enregistré dans 1 registre

ClinicalTrials.govNCT07564414Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 3 semaines

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2026-05-04; recorded start 2026-05-21
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 333 other studies in this databaseCounted from the lead sponsor named in the record (Novo Nordisk A/S)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 303 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 2,500 participants (target), run at 303 sites, across 19 countries.

How this score is built

Enrolment34/40
2,500 participants (target)
Site count25/25
303 sites
Country count15/15
19 countries
Planned duration7/10
Planned over about 23 months
Sponsor scale9/10
Novo Nordisk A/S has led 320 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Affections

Obesity
Type 2 Diabetes

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria : * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18 years or above at the time of signing the informed consent. * BMI≥ 35.0 kg/m\^2. * Participants without T2D: No history of T2D and HbA1c \< 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c \< 10% (\< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised. Exclusion Criteria: * A self-reported change in body weight \> 5% within 90 days before screening, irrespective of medical records. * Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	QUADRUPLE (4)
Recrutement	2 500 participants recherchés

Promoteur et collaborateurs

Novo Nordisk A/S Promoteur

Groupes et interventions

Cagrisema - dose level 1EXPERIMENTAL
Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.
Cagrisema - dose level 2ACTIVE_COMPARATOR
Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.
SemaglutideACTIVE_COMPARATOR
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.

Interventions

Médicament Cagrisema
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Médicament Semaglutide
Semaglutide will be administered subcutaneously.

Critères de jugement

Critère de jugement principal
Relative change in body weight
Measured as percentage (%).
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Relative change in body weight
Measured as %.
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Change in Body Mass Index (BMI)
Measured as kilograms per square metre (kg/m\^2).
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Number of participants who achieve greater than or equal to (≥) 30% weight reduction
Measured as count of participants.
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Number of participants who achieve ≥25% weight reduction
Measured as count of participants.
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Number of participants who achieve greater ≥ 20% weight reduction
Measured as count of participants.
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Change in waist circumference
Measured in centimetre (cm).
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Mean change in body weight
Measured in kilograms (kg).
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Number of participants who achieve a BMI less than (<) 30 kg/m^2
Measured as count of participants.
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Number of participants who achieve BMI <27 kg/m^2
Measured as count of participants.
Délai end of treatment (week 72)
Critère de jugement secondaire
Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2
Measured as count of participants.
Délai At end of treatment (week 72)
Critère de jugement secondaire
Number of participants who achieve a waist-to-height ratio < 0.53
Measured as count of participants.
Délai At end of treatment (week 72)
Critère de jugement secondaire
Ratio to baseline : Total cholesterol
Measured in terms of ratio.
Délai From baseline (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Ratio to baseline : High density lipoprotein (HDL) cholesterol
Measured in terms of ratio.
Délai From baseline (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Ratio to baseline : Low density lipoprotein (LDL) cholesterol
Measured in terms of ratio.
Délai From baseline (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol
Measured in terms of ratio.
Délai From baseline (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Ratio to baseline : Triglycerides
Measured in terms of ratio.
Délai From baseline (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Ratio to baseline: Free fatty acids
Measured in terms of ratio.
Délai From baseline (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Ratio to baseline : Non-HDL cholesterol
Measured in terms of ratio.
Délai From baseline (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function
Measured as score on a scale. The SF-36v2 acute measures health-related quality of life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Change in glycated haemoglobin (HbA1c)
Measured in %-points.
Délai From randomisation (week 0) to end of treatment (week 72)
Critère de jugement secondaire
Number of participants who achieve HbA1c <6.5%
Measured as count of participants.
Délai At end of treatment (week 72)
Critère de jugement secondaire
Number of participants who achieve normal HbA1c <5.7%
Measured as count of participants.
Délai At end of treatment (week 72)
Critère de jugement secondaire
Number of treatment-emergent adverse events (TEAEs)
Measured in number of events.
Délai From randomisation (week 0) to end of study (week 80)
Critère de jugement secondaire
Number of treatment-emergent serious adverse events (TESAEs)
Measured in number of events.
Délai From randomisation (week 0) to end of study (week 80)

Dates

Dates
Date de début	21 mai 2026 (réelle)
Achèvement principal	23 février 2028 (estimée)
Achèvement	19 avril 2028 (estimée)
Première publication	4 mai 2026 (réelle)
Dernière mise à jour	31 août 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	août 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

162 sites sont en recrutement

Argentina

Argentina
Établissement	Ville	État ou région	Statut
OMI- Organización Médica de Investigación	Buenos Aires		En recrutement
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli	Buenos Aires		En recrutement
Hospital Sirio Libanes	Buenos Aires		En recrutement
Kynet Recoleta	Buenos Aires		En recrutement
CEMEDIC	CABA	Buenos Aires	En recrutement
CEDIC Centro de Investigación Clínica	CABA		Pas encore en recrutement
CIPREC Arenales	CABA		En recrutement
Centro Médico Viamonte SRL	CABA		En recrutement
Centro de Investigaciones Metabólicas	Capital Federal	Buenos Aires	En recrutement
CICEMO- Consultorio (Av Directorio)	Ciudad Autónoma de Buenos Aires	Buenos Aires	En recrutement
Centro Médico Arsema	Ciudad Autónoma de Buenos Aires	Buenos Aires	En recrutement
Instituto Centenario	Ciudad de Buenos Aires		En recrutement
Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio	San Miguel de Tucumán	Tucumán Province	En recrutement
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe	Santa Fe		En recrutement
Sanatorio Norte	Santiago del Estero		En recrutement

Australia

Australia
Établissement	Ville	État ou région	Statut
University of Sunshine Coast - Vitality Village	Birtinya	Queensland	En recrutement
Emeritus Research Melbourne	Camberwell	Victoria	En recrutement
Sydney Clinical Trials	Campbelltown	New South Wales	En recrutement
Gosford Renal Research	Gosford	New South Wales	En recrutement
Sydney Cardiometabolic Centre	Liverpool	New South Wales	En recrutement
Hunter Diabetes Centre	Merewether	New South Wales	En recrutement
University of Sunshine Coast - South Brisbane	South Brisbane	Queensland	En recrutement

Austria

Austria
Établissement	Ville	Statut
Medical University of Graz	Graz	En recrutement
Ordination Winhofer-Stöckl	Mattersburg	En recrutement
Fließer-Görzer [Ordination]	Saint Stefan	En recrutement
Universitätsklinikum AKH Wien	Vienna	En recrutement
Klinik Landstraße	Vienna	En recrutement
Ordination Dr. Günter Sokol	Vienna	En recrutement
Klinik Hietzing 3. Med. Abt.	Vienna	En recrutement
Itariu [Ordination]	Vienna	En recrutement

Belgium

Belgium
Établissement	Ville	Statut
Anima Research Center	Alken	En recrutement
Cliniques universitaires Saint-Luc	Brussels	Pas encore en recrutement
KORMONT	Kluisbergen	En recrutement
CHU Tivoli	La Louvière	En recrutement
MECLINAS	Mechelen	En recrutement
AZ Delta - Roeselare	Roeselare	En recrutement
KORMONT	Zwalm	En recrutement

Bulgaria

Bulgaria
Établissement	Ville	Statut
MC For Life EOOD	Burgas	En recrutement
MC Kazanlak EOOD	Kazanlak	En recrutement
Medical center Medi City 21 OOD	Kyustendil	En recrutement
OCSOMCE - Dr. Albena Dinkova EOOD	Pleven	En recrutement
AIPSMCEMDID - Dr. Georgi Levterov EOOD	Plovdiv	En recrutement
DCC Sveti Georgi EOOD	Plovdiv	En recrutement
Hipocrat 9 - Dr. Rumyana Boykova - Draganova - AISPEMD EOOD	Sofia	En recrutement
DCC XX - Sofia EOOD, Endocrinology	Sofia	En recrutement
MC Diamedical - 2013 OOD, Sofia	Sofia	En recrutement
Medical Centre Medical Arts Medico-dental centre	Sofia	En recrutement
DCC XXV Sofia EOOD, Endocrinology Consulting room	Sofia	En recrutement
UMHAT Prof. Dr. Stoyan Kirkovich AD	Stara Zagora	En recrutement
AIPSMC Dr. Evelina Zlatanova EOOD	Varna	En recrutement

253 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07564414