Clinical trial NCT06221969: 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 With or Without an SGLT2 Inhibitor
Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 1000
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 well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.


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 ≥ 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 with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
* HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) of ≥ 30.0 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 \< 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 medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are 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 68)
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 68)
Secondary outcomes:
measure: Change in HbA1c
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])
timeFrame: At end of treatment (week 68)
measure: Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of greater than or equal to (≥) 5% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of ≥ 10% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of ≥ 15 % weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of ≥ 20 % weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in diastolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: non-HDL cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to end of study (week 74)
measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter)
timeFrame: From baseline (week 0) to end of study (week 74)
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 74)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama_Birmingham
state: Alabama
city: Gilbert
country: United States
facility: Prime Medical Group, LLC
state: Arizona
city: Phoenix
country: United States
facility: Velocity Clinical Research-Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Synexus Rsch /Cnt Phnx Med C
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Clinical Research
state: Arkansas
city: Searcy
country: United States
facility: Unity Health-Searcy Medical Center
state: Arkansas
city: Chula Vista
country: United States
facility: Velocity Clin Res-Chula Vista
state: California
city: Escondido
country: United States
facility: Headlands Research California, LLC
state: California
city: Escondido
country: United States
facility: Neighborhood Healthcare
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Yorba Linda - Pediatric Ste D
state: California
city: La Mesa
country: United States
facility: Diabetes & Endocrine Specialists - La Mesa
state: California
city: La Mesa
country: United States
facility: Diabetes and Endocrine Specialists - La Mesa
state: California
city: La Mesa
country: United States
facility: Velocity Clin Res San Diego
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Loma Linda
country: United States
facility: Loma Linda Univ Hlth Cr Endo
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare
state: California
city: Panorama City
country: United States
facility: Velocity Clin Res - Panorama
state: California
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
city: San Jose
country: United States
facility: Endocrinology Josel Cabaccan
state: California
city: San Mateo
country: United States
facility: Mills-Peninsula Medical Center
state: California
city: San Ramon
country: United States
facility: NorCal Endocrinology and Internal Medicine
state: California
city: Toluca Lake
country: United States
facility: Premier Medical Center, Inc.
state: California
city: Van Nuys
country: United States
facility: Velocity Clin Res - Panorama
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: Optumcare Colorado Springs
state: Colorado
city: Jacksonville
country: United States
facility: Northeast Res Inst. Inc.
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: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: Conyers
country: United States
facility: Hope Clin Res & Wellness
state: Georgia
city: Gainesville
country: United States
facility: Center for Adv Res & Education
state: Georgia
city: Marietta
country: United States
facility: Urban Family Practice Assoc
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Boise
country: United States
facility: St. Luke's Health System
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Gurnee
country: United States
facility: Clinical Invest Special_Gurnee
state: Illinois
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: Skokie
country: United States
facility: Evanston Premier Hlthcr Res
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes & Endo Res Ctr
state: Iowa
city: Topeka
country: United States
facility: Cotton-O'Neil Diab & Endo Ctr
state: Kansas
city: Hyattsville
country: United States
facility: MedStar Hlth Res Institute
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Belzoni
country: United States
facility: Belzoni Clinical Research
state: Mississippi
city: Gulfport
country: United States
facility: Velocity Clin Res Gulfport
state: Mississippi
city: Chesterfield
country: United States
facility: Diabetes & Endo Specialists Inc
state: Missouri
city: Saint Louis
country: United States
facility: Amicis Centers of Clinical Research
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research LLC
state: Missouri
city: Albuquerque
country: United States
facility: Velocity Clin Res Albuquerque
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College - Div of Community Endocrinology
state: New York
city: East Syracuse
country: United States
facility: Velocity Clin Res Syracuse
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group, LLP
state: New York
city: Chapel Hill
country: United States
facility: UNC Eastowne Clinical Research Unit
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research Inc.
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare/Research
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC
state: North Dakota
city: Columbus
country: United States
facility: Remington Davis Inc
state: Ohio
city: Maumee
country: United States
facility: Advanced Medical Research
state: Ohio
city: Wadsworth
country: United States
facility: New Venture Medical Research
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Horsham
country: United States
facility: CCT Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University_Philadelphia
state: Pennsylvania
city: Cumberland
country: United States
facility: Clinical Res Collaborative
state: Rhode Island
city: Anderson
country: United States
facility: Velocity Clinical Res-Anderson
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group Pc
state: Tennessee
city: Chattanooga
country: United States
facility: Univ Diab & Endo Consultants
state: Tennessee
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: Morristown
country: United States
facility: HealthStar Physicians PC
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Arlington
country: United States
facility: Arlington Family Res. Ctr Inc
state: Texas
city: Austin
country: United States
facility: Velocity Clin Res
state: Texas
city: Bellaire
country: United States
facility: UT Health University of Texas
state: Texas
city: Dallas
country: United States
facility: Velocity Clin Res, Dallas
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Synexus Clin Res Dallas
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: Houston
country: United States
facility: PrimeCare Medical Group
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC_Houston
state: Texas
city: Houston
country: United States
facility: Discovery MM Services, Inc
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Houston
country: United States
facility: Amir Ali Hassan, MD, PA
state: Texas
city: Lampasas
country: United States
facility: Fmc Science, Llc
state: Texas
city: San Antonio
country: United States
facility: Quality Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: University of Texas San Antonio
state: Texas
city: San Antonio
country: United States
facility: NE Clin Res of San Antonio
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Sugar Land
country: United States
facility: Mt Olympus Medical Research, LLC
state: Texas
city: Tomball
country: United States
facility: DM Clin Rsrch/Fam Diag Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J.Lewis Research Inc
state: Utah
city: West Jordan
country: United States
facility: Velocity Clin Res-Salt Lk City
state: Utah
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Renton
country: United States
facility: Rainier Clin Res Ctr Inc
state: Washington
city: Green Bay
country: United States
facility: Prevea Health
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Buenos Aires Mácula
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Instituto Medico Especializado_Capital Federal
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Metabolicas (IDIM)
city: Caba
country: Argentina
facility: Centro de Investigación Clínica
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: OMI- Organización Médica de Investigación
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CICEMO- Consultorio de Investigación Clínica EMO
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas
city: Santa Fe
country: Argentina
facility: CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
city: Blacktown
country: Australia
facility: Paratus Clinical
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical
state: New South Wales
city: Merewether
country: Australia
facility: Hunter Diabetes Centre
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Douglas
country: Australia
facility: Townsville University Hospital
state: Queensland
city: Morayfield
country: Australia
facility: University of Sunshine Coast
state: Queensland
city: Taringa
country: Australia
facility: Momentum Clinical Research
state: Queensland
city: Oaklands Park
country: Australia
facility: Southern Adelaide Diabetes & Endocrine Services
state: South Australia
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: St Albans
country: Australia
facility: Austrials
state: Victoria
city: St Albans
country: Australia
facility: Momentum Clinical Research
state: Victoria
city: Surrey
country: Canada
facility: TLC Diabetes and Endocrinology
state: British Columbia
city: Surrey
country: Canada
facility: Ocean West Research Clinic
state: British Columbia
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: London
country: Canada
facility: Milestone Research
state: Ontario
city: London
country: Canada
facility: Western Univ. Cnt for Studies in Fam Med
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: Montreal
country: Canada
facility: Centre Medical Acadie
state: Quebec
city: Terrebonne
country: Canada
facility: Ctr de Med Metab de Lanaudiere
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriaville
state: Quebec
city: Quebec
country: Canada
facility: Clin des Mal Lipid de Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Barranquilla
country: Colombia
facility: Clinica de la Costa
state: Atlántico
city: Barranquilla
country: Colombia
facility: Cimedical
city: Bogotá
country: Colombia
facility: Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S.
city: Bogotá
country: Colombia
facility: UNIENDO
city: Surat
country: India
facility: Nirmal Hospital Pvt. Ltd.
state: Gujarat
city: Vadodara
country: India
facility: SSG Hospital, Baroda
state: Gujarat
city: Belgaum
country: India
facility: Belgaum Diabetes Centre
state: Karnataka
city: Kozhikode
country: India
facility: Government Medical College, Kozhikode
state: Kerala
city: Thiruvnanthapuram
country: India
facility: Indian Institute of Diabetes
state: Kerela
city: Mumbai
country: India
facility: Seth GS Medical College & KEM Hospital
state: Maharashtra
city: Mumbai
country: India
facility: BSES MG hospital
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Chellaram Diabetes Institute
state: Maharashtra
city: Delhi
country: India
facility: Maulana Azad Medical College
state: New Delhi
city: Jaipur
country: India
facility: SMS Medical College & Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Diabetes, Thyroid and Endocrine Centre
state: Rajasthan
city: Vellore
country: India
facility: Christian Medical College Hospital, Vellore
state: Tamil Nadu
city: Hyderabad
country: India
facility: AIG Hospitals,Hyderabad
state: Telangana
city: Noida
country: India
facility: Government Institute of Medical Sciences
state: Uttar Pradesh
city: Kolkata,
country: India
facility: BP Poddar Hospital
state: West Bengal
city: Aligarh
country: India
facility: Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University
city: Chennai
country: India
facility: SRM Centre for Clinical Trials & Research
city: Surat
country: India
facility: Nirmal Hospital Pvt. Ltd.
city: Thriruvananthapuram
country: India
facility: Jothydev's Diabetes & Research Center
city: Boksburg
country: South Africa
facility: Dr Wilhase's rooms
state: Gauteng
city: Johannesburg
country: South Africa
facility: Ubuntu Clinical Research
state: Gauteng
city: Krugersdorp
country: South Africa
facility: Krugersdorp Medical Centre
state: Gauteng
city: Durban
country: South Africa
facility: Synapta Clinical Research Centre
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Dr J Reddy
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Bella Vita Clinical Research
state: Western Cape
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung City
country: Taiwan
facility: Kuang Tien General Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: