Clinical trial NCT06534411: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 1023
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.


Eligibility criteria: Inclusion Criteria:

* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening.
* Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
* Metformin
* sodium-glucose co-transporter 2 inhibitor (SGLT2i)
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) \>= 30 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
* Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
* Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye 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.

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Relative Change in Body Weight
timeFrame: From baseline (week 0) to end of treatment (week 60)
Secondary outcomes:
measure: Change in HbA1c
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol])
timeFrame: At end of treatment (week 60)
measure: Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol)
timeFrame: At end of treatment (week 60)
measure: Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Number of Participants Who Achieve >= 10% Weight Reduction
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Number of Participants Who Achieve >= 15% Weight Reduction
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Number of Participants Who Achieve >= 20% Weight Reduction
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Change in Waist Circumference
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Ratio to Baseline in Lipids: Total Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Ratio to Baseline in Lipids: Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Ratio to Baseline in Lipids: Non-HDL cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Change in Short Form (SF) -36v2 Score: Physical Component Summary Score
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Change in SF-36v2 Score: Mental Component Summary Score
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Change in SF-36v2 Score: Vitality Subscale
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Change in Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQOL-Lite-CT) : Physical Function score
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Change in IWQOL-Lite-CT: Total score
timeFrame: From baseline (week 0) to end of treatment (week 60)
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to end of study (week 66)
measure: Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (<54 Milligram per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter
timeFrame: From baseline (week 0) to end of study (week 66)
measure: Number of Severe Hypoglycaemic Episodes (Level 3): Hypoglycaemia Associated With Severe Cognitive Impairment Requiring External Assistance for Recovery, With no Specific Glucose Threshold
timeFrame: From baseline (week 0) to end of study (week 66)
Other outcomes:
Locations:
city: Pelham
country: United States
facility: Cahaba Research
state: Alabama
city: Phoenix
country: United States
facility: Velocity Clinical Research-Phoenix
state: Arizona
city: Tucson
country: United States
facility: AES Tucson DRS
state: Arizona
city: Little Rock
country: United States
facility: Woodland Int. Research Group
state: Arkansas
city: Concord
country: United States
facility: John Muir Physicians Network Clinical Research Center
state: California
city: La Mesa
country: United States
facility: Diabetes & Endocrine Specialists - La Mesa
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare
state: California
city: Van Nuys
country: United States
facility: Velocity Clin Res - Panorama
state: California
city: Colorado Springs
country: United States
facility: Optumcare Colorado Springs
state: Colorado
city: Washington
country: United States
facility: FEME Medical LLC
state: District of Columbia
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trial
state: Florida
city: Miami
country: United States
facility: Clinical Trial Services Corp
state: Florida
city: Miami
country: United States
facility: Bioclinical Research Alliance
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology
state: Florida
city: Orange City
country: United States
facility: Optimal Research Sites
state: Florida
city: Fayetteville
country: United States
facility: Javara Inc. / Privia Medical Group Georgia LLC
state: Georgia
city: Gurnee
country: United States
facility: Clinical Invest Special_Gurnee
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes & Endo Res Ctr
state: Iowa
city: Topeka
country: United States
facility: Cotton-Oneill Diabetes and End
state: Kansas
city: Richfield
country: United States
facility: AES Minneapolis DRS
state: Minnesota
city: Omaha
country: United States
facility: Univ of Nebraska Medical CTR
state: Nebraska
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare/Research
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Norman
country: United States
facility: Triad Research Institute
state: Oklahoma
city: Pottstown
country: United States
facility: Circuit Clinical - PMSI
state: Pennsylvania
city: Cumberland
country: United States
facility: Clinical Res Collaborative
state: Rhode Island
city: East Greenwich
country: United States
facility: Velocity Clin Res Providence
state: Rhode Island
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Austin
country: United States
facility: Velocity Clin Res Austin
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Lingvay
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC_Houston
state: Texas
city: Houston
country: United States
facility: Discovery MM Services - Houston - Broadway Street
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: Laredo
country: United States
facility: Aeres Clinical Research
state: Texas
city: McAllen
country: United States
facility: RGV Endocrine Center
state: Texas
city: Stephenville
country: United States
facility: Privia Health Javara Clin Res.
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: J.Lewis Research Inc
state: Utah
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Lanus Este
country: Argentina
facility: Centro Médico CIMEL
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Médicas Clínica de Fracturas y Or
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Fundación CESIM
state: La Pampa
city: San Miguel De Tucuimán
country: Argentina
facility: Centro de Investigaciones Médicas Tucumán
state: Tucumán
city: City of Buenos Aires
country: Argentina
facility: IMOBA
city: San Nicolás
country: Argentina
facility: Instituto de Investigaciones Clinicas San Nicolás
city: Bruce
country: Australia
facility: Paratus Clinical
state: Australian Capital Territory
city: Merewether
country: Australia
facility: Hunter Diabetes Centre
state: New South Wales
city: St Leonards
country: Australia
facility: Austrials
state: New South Wales
city: St Leonards
country: Australia
facility: Momentum Clinical Research
state: New South Wales
city: Sydney
country: Australia
facility: Roger Chih Yu Chen
state: New South Wales
city: Douglas
country: Australia
facility: Townsville University Hospital
state: Queensland
city: Herston
country: Australia
facility: Paratus Clinical
state: Queensland
city: Curitiba
country: Brazil
facility: Centro de Diabetes Curitiba
state: Parana
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica Ltda
state: Sao Paulo
city: Surrey
country: Canada
facility: Hilltop Medical Clinic
state: British Columbia
city: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Brampton
country: Canada
facility: Centricity Research Brampton
state: Ontario
city: Etobicoke
country: Canada
facility: Centricity Research Etobicoke
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Diabetes Heart Research Centre
state: Ontario
city: Laval
country: Canada
facility: Ctr de rech Clin de Laval
state: Quebec
city: Levis
country: Canada
facility: Alpha Recherche Clinique - Clinique de Levis
state: Quebec
city: Montreal
country: Canada
facility: Centre Medical Acadie
state: Quebec
city: Terrebonne
country: Canada
facility: Ctr de Med Metab de Lanaudiere
state: Quebec
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen
city: Essen
country: Germany
facility: Klinik für Endokrinologie, Diabetologie und Stoffwechsel - Uniklinik Essen
city: Essen
country: Germany
facility: Praxis am Markt Dr. Becker
city: Hamburg
country: Germany
facility: Wendisch/Dahl Hamburg (DZHW)
city: München
country: Germany
facility: Medicover Neuroendokrinologie MVZ
city: Münster
country: Germany
facility: MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
city: Wangen
country: Germany
facility: Zentrum für klinische Studien Allgäu Oberschwaben
city: Athens
country: Greece
facility: Alexandra General Hospital, Therapeutic Clinic
state: Attiki
city: Heraklion
country: Greece
facility: Venizeleio Pananeio
state: Crete
city: Athens
country: Greece
facility: Evangelismos Hospital
city: Athens
country: Greece
facility: Iatriko Athinon 'Palaiou Falirou'
city: Goudi/Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina,Internal Medicine
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki 'G. Gennimatas
city: Thessaloniki
country: Greece
facility: 'Ippokrateio' General Hospital of Thessaloniki
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
state: Csongrád-Csanád
city: Komárom
country: Hungary
facility: Selye János Kórház és Rendelőintézet
state: Komárom-Esztergom
city: Budapest
country: Hungary
facility: QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft
state: Pest
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: Budapest
country: Hungary
facility: Szőcs Depot Egészségügyi Szolgáltató Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: PVN Kutato Kft.
city: Budapest
country: Hungary
facility: MED-TIMA Kft.
city: Budapest
country: Hungary
facility: Észak-Pesti Centrumkórház Honvédkórház
city: Guntur
country: India
facility: Endolife Specialty Hospitals
state: Andhra Pradesh
city: New Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS)
state: Delhi
city: Bengaluru
country: India
facility: Ramaiah Memorial Hospital
state: Karnataka
city: Wardha
country: India
facility: Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
state: Maharashtra
city: Ajmer
country: India
facility: Jawahar Lal Nehru Govt. Medical College
state: Rajasthan
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Diabetes, Thyroid and Endocrine Centre
state: Rajasthan
city: Madurai
country: India
facility: Arthur Asirvatham hospital,
state: Tamil Nadu
city: Hyderabad
country: India
facility: AIG Hospitals,Hyderabad
state: Telangana
city: Lucknow
country: India
facility: Udyaan Health Care
state: Uttar Pradesh
city: Kolkata
country: India
facility: IPGME&R and SSKM Hospital
state: West Bengal
city: Haifa
country: Israel
facility: Diabetes and obesity center of excellence, Rambam MC
city: Herzeliya
country: Israel
facility: Clalit sick fund Herzeliya
city: Holon
country: Israel
facility: Diabetes Clinic Wolfson MC
city: Jerusalem
country: Israel
facility: Diabetes Unit Hadassah Ein Karem MC
city: Petah-Tikva
country: Israel
facility: Rabin MC Beilinson Campus Endo
city: Tel Hashomer
country: Israel
facility: Endrocrinolgy Clinic - Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Institute of Endocrinology, metabolism and hypertension
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie Voivodeship
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Chorzów
country: Poland
facility: Diab Serwis Popenda Spółka Jawna
city: Gorzow Wielkopolski
country: Poland
facility: Specjalistyczny Gabinet Diabetologiczny Rumianowski Radosław
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
city: Olsztyn
country: Poland
facility: Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
city: Sosnowiec
country: Poland
facility: Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
city: Oradea
country: Romania
facility: Diabdana S.R.L.
state: Bihor
city: Bucharest
country: Romania
facility: Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
state: Bucurestii
city: Baia Mare
country: Romania
facility: CMI Dr Pop Lavinia
state: Maramures
city: Tirgu Mures
country: Romania
facility: Sc Mediab Srl
state: Mures
city: Bucharest
country: Romania
facility: SC Nutrilife SRL
city: Bucuresti
country: Romania
facility: Diabet Med SRL
city: Bucuresti
country: Romania
facility: Sanamed Hospital SRL
city: Satu-Mare
country: Romania
facility: Clinica Korall S.R.L. Satu Mare
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Almeria
country: Spain
facility: Centro Periferico De Especialidades Bola Azul
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Sevilla
country: Spain
facility: Clínica Nuevas Tecnologías en Diabetes y Endocrinología
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Kaoshiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: