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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

Phase 32.500 Teilnehmende gesucht303 Studienzentren19 Länder

Kategorien

Endokrin und metabolisch100%

In 1 Register registriert

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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.

Zusammenfassung

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

Erkrankungen

Obesity
Type 2 Diabetes

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	QUADRUPLE (4)
Teilnahme	2.500 Teilnehmende gesucht

Sponsor und Mitwirkende

Novo Nordisk A/S Sponsor

Studienarme und Interventionen

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.

Interventionen

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

Endpunkte

Primärer Endpunkt
Relative change in body weight
Measured as percentage (%).
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Relative change in body weight
Measured as %.
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Change in Body Mass Index (BMI)
Measured as kilograms per square metre (kg/m\^2).
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Number of participants who achieve greater than or equal to (≥) 30% weight reduction
Measured as count of participants.
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Number of participants who achieve ≥25% weight reduction
Measured as count of participants.
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Number of participants who achieve greater ≥ 20% weight reduction
Measured as count of participants.
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Change in waist circumference
Measured in centimetre (cm).
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Mean change in body weight
Measured in kilograms (kg).
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Number of participants who achieve a BMI less than (<) 30 kg/m^2
Measured as count of participants.
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Number of participants who achieve BMI <27 kg/m^2
Measured as count of participants.
Zeitrahmen end of treatment (week 72)
Sekundärer Endpunkt
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.
Zeitrahmen At end of treatment (week 72)
Sekundärer Endpunkt
Number of participants who achieve a waist-to-height ratio < 0.53
Measured as count of participants.
Zeitrahmen At end of treatment (week 72)
Sekundärer Endpunkt
Ratio to baseline : Total cholesterol
Measured in terms of ratio.
Zeitrahmen From baseline (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Ratio to baseline : High density lipoprotein (HDL) cholesterol
Measured in terms of ratio.
Zeitrahmen From baseline (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Ratio to baseline : Low density lipoprotein (LDL) cholesterol
Measured in terms of ratio.
Zeitrahmen From baseline (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol
Measured in terms of ratio.
Zeitrahmen From baseline (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Ratio to baseline : Triglycerides
Measured in terms of ratio.
Zeitrahmen From baseline (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Ratio to baseline: Free fatty acids
Measured in terms of ratio.
Zeitrahmen From baseline (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Ratio to baseline : Non-HDL cholesterol
Measured in terms of ratio.
Zeitrahmen From baseline (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
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.
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
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.
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Change in glycated haemoglobin (HbA1c)
Measured in %-points.
Zeitrahmen From randomisation (week 0) to end of treatment (week 72)
Sekundärer Endpunkt
Number of participants who achieve HbA1c <6.5%
Measured as count of participants.
Zeitrahmen At end of treatment (week 72)
Sekundärer Endpunkt
Number of participants who achieve normal HbA1c <5.7%
Measured as count of participants.
Zeitrahmen At end of treatment (week 72)
Sekundärer Endpunkt
Number of treatment-emergent adverse events (TEAEs)
Measured in number of events.
Zeitrahmen From randomisation (week 0) to end of study (week 80)
Sekundärer Endpunkt
Number of treatment-emergent serious adverse events (TESAEs)
Measured in number of events.
Zeitrahmen From randomisation (week 0) to end of study (week 80)

Daten

Daten
Startdatum	21. Mai 2026 (tatsächlich)
Primärer Abschluss	23. Februar 2028 (geschätzt)
Abschluss	19. April 2028 (geschätzt)
Erstveröffentlichung	4. Mai 2026 (tatsächlich)
Zuletzt aktualisiert	31. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	August 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

162 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Bundesland oder Region	Status
OMI- Organización Médica de Investigación	Buenos Aires		Rekrutiert
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli	Buenos Aires		Rekrutiert
Hospital Sirio Libanes	Buenos Aires		Rekrutiert
Kynet Recoleta	Buenos Aires		Rekrutiert
CEMEDIC	CABA	Buenos Aires	Rekrutiert
CEDIC Centro de Investigación Clínica	CABA		Rekrutierung noch nicht begonnen
CIPREC Arenales	CABA		Rekrutiert
Centro Médico Viamonte SRL	CABA		Rekrutiert
Centro de Investigaciones Metabólicas	Capital Federal	Buenos Aires	Rekrutiert
CICEMO- Consultorio (Av Directorio)	Ciudad Autónoma de Buenos Aires	Buenos Aires	Rekrutiert
Centro Médico Arsema	Ciudad Autónoma de Buenos Aires	Buenos Aires	Rekrutiert
Instituto Centenario	Ciudad de Buenos Aires		Rekrutiert
Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio	San Miguel de Tucumán	Tucumán Province	Rekrutiert
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe	Santa Fe		Rekrutiert
Sanatorio Norte	Santiago del Estero		Rekrutiert

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
University of Sunshine Coast - Vitality Village	Birtinya	Queensland	Rekrutiert
Emeritus Research Melbourne	Camberwell	Victoria	Rekrutiert
Sydney Clinical Trials	Campbelltown	New South Wales	Rekrutiert
Gosford Renal Research	Gosford	New South Wales	Rekrutiert
Sydney Cardiometabolic Centre	Liverpool	New South Wales	Rekrutiert
Hunter Diabetes Centre	Merewether	New South Wales	Rekrutiert
University of Sunshine Coast - South Brisbane	South Brisbane	Queensland	Rekrutiert

Austria

Austria
Einrichtung	Stadt	Status
Medical University of Graz	Graz	Rekrutiert
Ordination Winhofer-Stöckl	Mattersburg	Rekrutiert
Fließer-Görzer [Ordination]	Saint Stefan	Rekrutiert
Universitätsklinikum AKH Wien	Vienna	Rekrutiert
Klinik Landstraße	Vienna	Rekrutiert
Ordination Dr. Günter Sokol	Vienna	Rekrutiert
Klinik Hietzing 3. Med. Abt.	Vienna	Rekrutiert
Itariu [Ordination]	Vienna	Rekrutiert

Belgium

Belgium
Einrichtung	Stadt	Status
Anima Research Center	Alken	Rekrutiert
Cliniques universitaires Saint-Luc	Brussels	Rekrutierung noch nicht begonnen
KORMONT	Kluisbergen	Rekrutiert
CHU Tivoli	La Louvière	Rekrutiert
MECLINAS	Mechelen	Rekrutiert
AZ Delta - Roeselare	Roeselare	Rekrutiert
KORMONT	Zwalm	Rekrutiert

Bulgaria

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

253 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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