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
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT06221969
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CagriSema Cagrilintide Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks. CagriSema Semaglutide Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks. Tirzepatide Tirzepatide Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.
- Primary Outcome Measures
Name Time Method Change in glycated haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 68) Measured in percentage (%)-points.
Relative change in body weight From baseline (week 0) to end of treatment (week 68) Measured in percentage (%).
- Secondary Outcome Measures
Name Time Method Change in HbA1c From baseline (week 0) to end of treatment (week 68) Measured in %-points.
Achievement of ≥ 15 % weight reduction From baseline (week 0) to end of treatment (week 68) Count of participant
Change in systolic blood pressure From baseline (week 0) to end of treatment (week 68) Measured in millimeters of mercury(mmHg).
Change in waist circumference From baseline (week 0) to end of treatment (week 68) Measured in centimeter (cm).
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Change in fasting plasma glucose (FPG) From baseline (week 0) to end of treatment (week 68) Measured in millimoles per liter (mmol/L).
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol]) At end of treatment (week 68) Count of participant
Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol) From baseline (week 0) to end of treatment (week 68) Count of participant
Achievement of greater than or equal to (≥) 5% weight reduction From baseline (week 0) to end of treatment (week 68) Count of participant
Change in diastolic blood pressure From baseline (week 0) to end of treatment (week 68) Measured in mmHg.
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter) From baseline (week 0) to end of study (week 74) Count of episodes
Achievement of ≥ 10% weight reduction From baseline (week 0) to end of treatment (week 68) Count of participant
Achievement of ≥ 20 % weight reduction From baseline (week 0) to end of treatment (week 68) Count of participant
Ratio to baseline in lipids: Total cholesterol From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey From baseline (week 0) to end of treatment (week 68) The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale.
Ratio to baseline in lipids: Triglycerides From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Number of Treatment-emergent Adverse Events (TEAEs) From baseline (week 0) to end of study (week 74) Count of events
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Ratio to baseline in lipids: non-HDL cholesterol From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3 From baseline (week 0) to end of treatment (week 68) IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0-100), Physical Function composite (0-100). Total score (0-100). Higher scores indicate better level of functioning.
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold From baseline (week 0) to end of study (week 74) Count of episodes
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (175)
South Broward Research LLC
🇺🇸Miramar, Florida, United States
West Orange Endocrinology
🇺🇸Ocoee, Florida, United States
Optimal Research Sites
🇺🇸Orange City, Florida, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
Hope Clin Res & Wellness
🇺🇸Conyers, Georgia, United States
Prime Medical Group, LLC
🇺🇸Gilbert, Arizona, United States
Bioclinical Research Alliance
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Univ of Alabama_Birmingham
🇺🇸Birmingham, Alabama, United States
Velocity Clinical Research-Phoenix
🇺🇸Phoenix, Arizona, United States
Synexus Rsch /Cnt Phnx Med C
🇺🇸Phoenix, Arizona, United States
Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
Unity Health-Searcy Medical Center
🇺🇸Searcy, Arkansas, United States
Velocity Clin Res-Chula Vista
🇺🇸Chula Vista, California, United States
Headlands Research California, LLC
🇺🇸Escondido, California, United States
Neighborhood Healthcare
🇺🇸Escondido, California, United States
St. Jude Heritage Yorba Linda - Pediatric Ste D
🇺🇸Fullerton, California, United States
Diabetes & Endocrine Specialists - La Mesa
🇺🇸La Mesa, California, United States
Diabetes and Endocrine Specialists - La Mesa
🇺🇸La Mesa, California, United States
Velocity Clin Res San Diego
🇺🇸La Mesa, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Loma Linda Univ Hlth Cr Endo
🇺🇸Loma Linda, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Desert Oasis Healthcare
🇺🇸Palm Springs, California, United States
Velocity Clin Res - Panorama
🇺🇸Van Nuys, California, United States
Western University of Health Sciences
🇺🇸Pomona, California, United States
Endocrinology Josel Cabaccan
🇺🇸San Jose, California, United States
Mills-Peninsula Medical Center
🇺🇸San Mateo, California, United States
NorCal Endocrinology and Internal Medicine
🇺🇸San Ramon, California, United States
Premier Medical Center, Inc.
🇺🇸Toluca Lake, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Optumcare Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Northeast Res Inst. Inc.
🇺🇸Jacksonville, Florida, United States
Clinical Trial Services Corp
🇺🇸Miami, Florida, United States
Center for Adv Res & Education
🇺🇸Gainesville, Georgia, United States
Urban Family Practice Assoc
🇺🇸Marietta, Georgia, United States
Endocrine Research Solutions
🇺🇸Roswell, Georgia, United States
St. Luke's Health System
🇺🇸Boise, Idaho, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Clinical Invest Special_Gurnee
🇺🇸Gurnee, Illinois, United States
Endeavor Health
🇺🇸Skokie, Illinois, United States
Evanston Premier Hlthcr Res
🇺🇸Skokie, Illinois, United States
Iowa Diabetes & Endo Res Ctr
🇺🇸West Des Moines, Iowa, United States
Cotton-O'Neil Diab & Endo Ctr
🇺🇸Topeka, Kansas, United States
MedStar Hlth Res Institute
🇺🇸Hyattsville, Maryland, United States
Joslin Center For Diabetes
🇺🇸Boston, Massachusetts, United States
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Belzoni Clinical Research
🇺🇸Belzoni, Mississippi, United States
Velocity Clin Res Gulfport
🇺🇸Gulfport, Mississippi, United States
Diabetes & Endo Specialists Inc
🇺🇸Chesterfield, Missouri, United States
Amicis Centers of Clinical Research
🇺🇸Saint Louis, Missouri, United States
StudyMetrix Research LLC
🇺🇸Saint Peters, Missouri, United States
Velocity Clin Res Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Albany Medical College - Endo
🇺🇸Albany, New York, United States
Velocity Clin Res Syracuse
🇺🇸East Syracuse, New York, United States
Southgate Medical Group, LLP
🇺🇸West Seneca, New York, United States
UNC Eastowne Clinical Research Unit
🇺🇸Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
🇺🇸Greensboro, North Carolina, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Lucas Research Inc.
🇺🇸Morehead City, North Carolina, United States
Piedmont Healthcare/Research
🇺🇸Statesville, North Carolina, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
Plains Clinical Research Center, LLC
🇺🇸Fargo, North Dakota, United States
Remington Davis Inc
🇺🇸Columbus, Ohio, United States
Advanced Medical Research
🇺🇸Maumee, Ohio, United States
New Venture Medical Research
🇺🇸Wadsworth, Ohio, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
CCT Research
🇺🇸Horsham, Pennsylvania, United States
Thomas Jefferson University_Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Res Collaborative
🇺🇸Cumberland, Rhode Island, United States
Velocity Clinical Res-Anderson
🇺🇸Anderson, South Carolina, United States
Trial Management Associates
🇺🇸Myrtle Beach, South Carolina, United States
Hillcrest Clinical Research
🇺🇸Simpsonville, South Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Holston Medical Group Pc
🇺🇸Bristol, Tennessee, United States
Univ Diab & Endo Consultants
🇺🇸Chattanooga, Tennessee, United States
Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Clinical Neuroscience Solutions
🇺🇸Memphis, Tennessee, United States
HealthStar Physicians PC
🇺🇸Morristown, Tennessee, United States
Clinical Research Associates
🇺🇸Nashville, Tennessee, United States
Arlington Family Res. Ctr Inc
🇺🇸Arlington, Texas, United States
Velocity Clin Res
🇺🇸Austin, Texas, United States
UT Health University of Texas
🇺🇸Bellaire, Texas, United States
Velocity Clin Res, Dallas
🇺🇸Dallas, Texas, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
Synexus Clin Res Dallas
🇺🇸Dallas, Texas, United States
Cedar Health Research
🇺🇸Dallas, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Amir Ali Hassan, MD, PA
🇺🇸Houston, Texas, United States
Fmc Science, Llc
🇺🇸Lampasas, Texas, United States
Quality Clinical Research, Inc.
🇺🇸San Antonio, Texas, United States
University of Texas San Antonio
🇺🇸San Antonio, Texas, United States
PrimeCare Medical Group
🇺🇸Houston, Texas, United States
Juno Research, LLC_Houston
🇺🇸Houston, Texas, United States
Discovery MM Services, Inc
🇺🇸Houston, Texas, United States
NE Clin Res of San Antonio
🇺🇸San Antonio, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Mt Olympus Medical Research, LLC
🇺🇸Sugar Land, Texas, United States
DM Clin Rsrch/Fam Diag Clinic
🇺🇸Tomball, Texas, United States
Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
J.Lewis Research Inc
🇺🇸South Jordan, Utah, United States
Velocity Clin Res-Salt Lk City
🇺🇸West Jordan, Utah, United States
TPMG Clinical Research
🇺🇸Newport News, Virginia, United States
Rainier Clin Res Ctr Inc
🇺🇸Renton, Washington, United States
Instituto Medico Especializado_Capital Federal
🇦🇷Ciudad de Buenos Aires, Buenos Aires, Argentina
Centro de Investigación Clínica
🇦🇷Caba, Argentina
OMI- Organización Médica de Investigación
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
CICEMO- Consultorio de Investigación Clínica EMO
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Instituto de Investigaciones Clinicas
🇦🇷Mar del Plata, Argentina
Prevea Health
🇺🇸Green Bay, Wisconsin, United States
Townsville University Hospital
🇦🇺Douglas, Queensland, Australia
Buenos Aires Mácula
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Metabolicas (IDIM)
🇦🇷Buenos Aires, Argentina
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
🇦🇷Santa Fe, Argentina
Paratus Clinical
🇦🇺Kanwal, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
University of Sunshine Coast
🇦🇺Morayfield, Queensland, Australia
Hilltop Medical Clinic
🇨🇦Surrey, British Columbia, Canada
Momentum Clinical Research
🇦🇺St Albans, Victoria, Australia
G.A. Research Associates Ltd.
🇨🇦Moncton, New Brunswick, Canada
Milestone Research
🇨🇦London, Ontario, Canada
Ctr de Med Metab de Lanaudiere
🇨🇦Terrebonne, Quebec, Canada
Southern Adelaide Diabetes & Endocrine Services
🇦🇺Oaklands Park, South Australia, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Austrials
🇦🇺St Albans, Victoria, Australia
TLC Diabetes and Endocrinology
🇨🇦Surrey, British Columbia, Canada
Ocean West Research Clinic
🇨🇦Surrey, British Columbia, Canada
Western Univ. Cnt for Studies in Fam Med
🇨🇦London, Ontario, Canada
Centre Medical Acadie
🇨🇦Montreal, Quebec, Canada
Centricity Research Brampton
🇨🇦Brampton, Ontario, Canada
London Road Diagnostic Clinic and Medical Centre
🇨🇦Sarnia, Ontario, Canada
Diabetes Heart Research Centre
🇨🇦Toronto, Ontario, Canada
Centre de Recherche Saint-Louis
🇨🇦Quebec, Canada
Clinica de la Costa
🇨🇴Barranquilla, Atlántico, Colombia
Cimedical
🇨🇴Barranquilla, Colombia
Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S.
🇨🇴Bogotá, Colombia
UNIENDO
🇨🇴Bogotá, Colombia
Nirmal Hospital Pvt. Ltd.
🇮🇳Surat, India
SSG Hospital, Baroda
🇮🇳Vadodara, Gujarat, India
Belgaum Diabetes Centre
🇮🇳Belgaum, Karnataka, India
Diex Recherche Victoriaville
🇨🇦Victoriaville, Quebec, Canada
Clin des Mal Lipid de Quebec
🇨🇦Quebec, Canada
Government Medical College, Kozhikode
🇮🇳Kozhikode, Kerala, India
Indian Institute of Diabetes
🇮🇳Thiruvnanthapuram, Kerela, India
Seth GS Medical College & KEM Hospital
🇮🇳Mumbai, Maharashtra, India
BSES MG hospital
🇮🇳Mumbai, Maharashtra, India
Grant Medical Foundation Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India
Chellaram Diabetes Institute
🇮🇳Pune, Maharashtra, India
Maulana Azad Medical College
🇮🇳Delhi, New Delhi, India
SMS Medical College & Hospital
🇮🇳Jaipur, Rajasthan, India
Diabetes, Thyroid and Endocrine Centre
🇮🇳Jaipur, Rajasthan, India
Christian Medical College Hospital, Vellore
🇮🇳Vellore, Tamil Nadu, India
AIG Hospitals,Hyderabad
🇮🇳Hyderabad, Telangana, India
Government Institute of Medical Sciences
🇮🇳Noida, Uttar Pradesh, India
BP Poddar Hospital
🇮🇳Kolkata,, West Bengal, India
Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University
🇮🇳Aligarh, India
SRM Centre for Clinical Trials & Research
🇮🇳Chennai, India
Jothydev's Diabetes & Research Center
🇮🇳Thriruvananthapuram, India
Dr Wilhase's rooms
🇿🇦Boksburg, Gauteng, South Africa
Ubuntu Clinical Research
🇿🇦Johannesburg, Gauteng, South Africa
Krugersdorp Medical Centre
🇿🇦Krugersdorp, Gauteng, South Africa
Synapta Clinical Research Centre
🇿🇦Durban, KwaZulu-Natal, South Africa
Dr J Reddy
🇿🇦Durban, KwaZulu-Natal, South Africa
Bella Vita Clinical Research
🇿🇦Cape Town, Western Cape, South Africa
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung City, Taiwan
Kuang Tien General Hospital
🇨🇳Taichung City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan