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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

المرحلة 3مطلوب 2,500 مشارك303 مواقع19 دولة

الفئات

الغدد الصمّاء والأيض100%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT07564414فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل 3 أسابيع

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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

الحالات

Obesity
Type 2 Diabetes

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	المرحلة 3
التخصيص	معشّاة
نموذج التدخّل	PARALLEL
الغرض الأساسي	TREATMENT
التعمية	QUADRUPLE (4)
التجنيد	مطلوب 2,500 مشارك

الجهة الراعية والمتعاونون

Novo Nordisk A/S الجهة الراعية

الأذرع والتدخلات

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.

التدخلات

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

مقاييس النتائج

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

التواريخ

التواريخ
تاريخ البدء	21 مايو 2026 (فعلي)
الإتمام الأولي	23 فبراير 2028 (تقديري)
الإتمام	19 أبريل 2028 (تقديري)
أول نشر	4 مايو 2026 (فعلي)
آخر تحديث	31 أغسطس 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	أغسطس 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

162 موقعاً قيد التجنيد

Argentina

Argentina
المنشأة	المدينة	الولاية أو المنطقة	الحالة
OMI- Organización Médica de Investigación	Buenos Aires		قيد التجنيد
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli	Buenos Aires		قيد التجنيد
Hospital Sirio Libanes	Buenos Aires		قيد التجنيد
Kynet Recoleta	Buenos Aires		قيد التجنيد
CEMEDIC	CABA	Buenos Aires	قيد التجنيد
CEDIC Centro de Investigación Clínica	CABA		لم يبدأ التجنيد بعد
CIPREC Arenales	CABA		قيد التجنيد
Centro Médico Viamonte SRL	CABA		قيد التجنيد
Centro de Investigaciones Metabólicas	Capital Federal	Buenos Aires	قيد التجنيد
CICEMO- Consultorio (Av Directorio)	Ciudad Autónoma de Buenos Aires	Buenos Aires	قيد التجنيد
Centro Médico Arsema	Ciudad Autónoma de Buenos Aires	Buenos Aires	قيد التجنيد
Instituto Centenario	Ciudad de Buenos Aires		قيد التجنيد
Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio	San Miguel de Tucumán	Tucumán Province	قيد التجنيد
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe	Santa Fe		قيد التجنيد
Sanatorio Norte	Santiago del Estero		قيد التجنيد

Australia

Australia
المنشأة	المدينة	الولاية أو المنطقة	الحالة
University of Sunshine Coast - Vitality Village	Birtinya	Queensland	قيد التجنيد
Emeritus Research Melbourne	Camberwell	Victoria	قيد التجنيد
Sydney Clinical Trials	Campbelltown	New South Wales	قيد التجنيد
Gosford Renal Research	Gosford	New South Wales	قيد التجنيد
Sydney Cardiometabolic Centre	Liverpool	New South Wales	قيد التجنيد
Hunter Diabetes Centre	Merewether	New South Wales	قيد التجنيد
University of Sunshine Coast - South Brisbane	South Brisbane	Queensland	قيد التجنيد

Austria

Austria
المنشأة	المدينة	الحالة
Medical University of Graz	Graz	قيد التجنيد
Ordination Winhofer-Stöckl	Mattersburg	قيد التجنيد
Fließer-Görzer [Ordination]	Saint Stefan	قيد التجنيد
Universitätsklinikum AKH Wien	Vienna	قيد التجنيد
Klinik Landstraße	Vienna	قيد التجنيد
Ordination Dr. Günter Sokol	Vienna	قيد التجنيد
Klinik Hietzing 3. Med. Abt.	Vienna	قيد التجنيد
Itariu [Ordination]	Vienna	قيد التجنيد

Belgium

Belgium
المنشأة	المدينة	الحالة
Anima Research Center	Alken	قيد التجنيد
Cliniques universitaires Saint-Luc	Brussels	لم يبدأ التجنيد بعد
KORMONT	Kluisbergen	قيد التجنيد
CHU Tivoli	La Louvière	قيد التجنيد
MECLINAS	Mechelen	قيد التجنيد
AZ Delta - Roeselare	Roeselare	قيد التجنيد
KORMONT	Zwalm	قيد التجنيد

Bulgaria

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

يُدرَج 253 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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