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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Cagrilintide; Drug: Semaglutide; Drug: Tirzepatide

• Study Type: Interventional
• Enrollment (Actual): 1024
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1012AAR
    • Instituto de Investigaciones Metabólicas (IDIM)
  • Buenos Aires, Argentina, C1015
    • OMI- Organización Médica de Investigación
  • Buenos Aires, Argentina, C1405BUB
    • CICEMO- Consultorio de Investigación Clínica EMO
  • CABA, Argentina, C1060ABA
    • Centro de Investigacion Clinica
  • CABA, Argentina, C1060ABA
    • CEDIC Centro de Investigación Clínica
  • Santa Fe, Argentina, S3000FSO
    • CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1061AAE
      • Buenos Aires Mácula
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BUB
      • CICEMO- Consultorio de Investigación Clínica EMO
    • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1405CWB
      • Instituto Medico Especializado_Capital Federal
    • Mar del Plata, Buenos Aires, Argentina, B7600FZN
      • Instituto de Investigaciones Clinicas Mar del Plata
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Paratus Clinical
    • Kanwal, New South Wales, Australia, 2259
      • Paratus Clinical
    • Merewether, New South Wales, Australia, 2291
      • Hunter Diabetes Centre
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • Townsville University Hospital
    • Morayfield, Queensland, Australia, 4506
      • University of Sunshine Coast - Morayfield
    • Taringa, Queensland, Australia, 4068
      • Momentum Clinical Research Taringa
  • South Australia
    • Oaklands Park, South Australia, Australia, 5046
      • Southern Adelaide Diabetes & Endocrine services
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital - Diabetes & Endocrinology Department
    • St Albans, Victoria, Australia, 3021
      • Austrials
    • St Albans, Victoria, Australia, 3021
      • Momentum Clinical Research Sunshine
• Canada
  • Québec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • Québec, Canada, G1V 4W2
    • Clin des Mal Lipid de Quebec
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
      • Centricity Research Calgary Endocrinology
  • British Columbia
    • Surrey, British Columbia, Canada, V3Z 2N6
      • Ocean West Research Clinic
    • Surrey, British Columbia, Canada, V4A 0C1
      • Hilltop Medical Clinic
    • Surrey, British Columbia, Canada, V3R 4H6
      • Guilford Med Clinic
    • Surrey, British Columbia, Canada, V3T0X6
      • TLC Diabetes and Endocrinology
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • G.A. Research Associates Ltd.
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Centricity Research Brampton Endocrinology
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research
    • London, Ontario, Canada, N6G 2M1
      • Western Univ. Cnt for Studies in Fam Med
    • Sarnia, Ontario, Canada, N7T 4X3
      • London Road Diagnostic Clinic and Medical Centre
    • Toronto, Ontario, Canada, M6G 1M2
      • Diabetes Heart Research Centre
    • Toronto, Ontario, Canada, M4G 3E8
      • Centricity Research Toronto
  • Quebec
    • Montreal, Quebec, Canada, H4N 2W2
      • Centre Medical Acadie
    • Québec, Quebec, Canada, G3K 2P8
      • ALPHA Recherche Clinique
    • Terrebonne, Quebec, Canada, J6X 4P7
      • Ctr de Med Metab de Lanaudiere
    • Victoriaville, Quebec, Canada, G6P 3Z8
      • Diex Recherche Victoriaville
  • West Oshawa
    • Barrie, West Oshawa, Canada, L4N 7L3
      • Centricity Research Oshawa
• Colombia
  • Barranquilla, Colombia, 80001
    • Cimedical
  • Bogotá, Colombia, 110221
    • Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S.
  • Bogotá, Colombia, 110111
    • UNIENDO
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 80020
      • Clinica de la Costa
  • Santander Department
    • Floridablanca, Santander Department, Colombia, 681004
      • FOSCAL
• India
  • Aligarh, India, 202002
    • Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University
  • Chennai, India, 603203
    • SRM Centre for Clinical Trials & Research
  • Surat, India, 395002
    • Nirmal Hospital Pvt. Ltd.
  • Thriruvananthapuram, India, 695 032
    • Jothydev's Diabetes & Research Center
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital Pvt. Ltd.
    • Vadodara, Gujarat, India, 390001
      • SSG Hospital, Baroda
  • Karnataka
    • Belagavi, Karnataka, India, 590001
      • Belgaum Diabetes Centre
  • Kerala
    • Kozhikode, Kerala, India, 673008
      • Government Medical College, Kozhikode
    • Thiruvnanthapuram, Kerala, India, 695033
      • Indian Institute of Diabetes
  • Maharashtra
    • Mumbai, Maharashtra, India, 400058
      • BSES MG hospital
    • Mumbai, Maharashtra, India, 400012
      • Seth GS Medical College & KEM Hospital
    • Pune, Maharashtra, India, 411001
      • Grant Medical foundation Ruby Hall Clinic
    • Pune, Maharashtra, India, 411021
      • Chellaram Diabetes Institute
  • New Delhi
    • Delhi, New Delhi, India, 110002
      • Maulana Azad Medical College
  • Rajasthan
    • Jaipur, Rajasthan, India, 302004
      • SMS Medical College & Hospital
    • Jaipur, Rajasthan, India, 302006
      • Diabetes, Thyroid and Endocrine Centre
  • Tamil Nadu
    • Vellore, Tamil Nadu, India, 632004
      • Christian Medical College Hospital, Vellore
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • AIG Hospitals,Hyderabad
  • Uttar Pradesh
    • Noida, Uttar Pradesh, India, 201310
      • Government Institute of Medical Sciences
  • West Bengal
    • Kolkata, West Bengal, India, 700053
      • BP Poddar Hospital
• South Africa
  • Gauteng
    • Boksburg, Gauteng, South Africa, 1466
      • Dr Wilhase's rooms
    • Johannesburg, Gauteng, South Africa, 1827
      • Ubuntu Clinical Research
    • Krugersdorp, Gauteng, South Africa, 1739
      • Krugersdorp Medical Centre
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4450
      • Dr J Reddy
    • Durban, KwaZulu-Natal, South Africa, 4001
      • Synapta Clinical Research Centre
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7560
      • Bella Vita Clinical Research
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 433
    • Kuang Tien General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital_main
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Univ of Alabama_Birmingham
    • Birmingham, Alabama, United States, 35211
      • Synexus Clin Res-Birmingham
  • Arizona
    • Gilbert, Arizona, United States, 85296
      • Prime Medical Group, LLC
    • Phoenix, Arizona, United States, 85006
      • Velocity Clinical Research-Phoenix
    • Phoenix, Arizona, United States, 85020
      • Synexus Rsch /Cnt Phnx Med C
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Clinical Research
    • Searcy, Arkansas, United States, 72143
      • Unity Health-Searcy Medical Center
  • California
    • Chula Vista, California, United States, 91911
      • Velocity Clin Res-Chula Vista
    • Escondido, California, United States, 92025
      • Neighborhood Healthcare
    • Escondido, California, United States, 92025
      • Headlands Research California, LLC
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Yorba Linda - Pediatric Ste D
    • La Mesa, California, United States, 91942
      • Diabetes and Endocrine Specialists - La Mesa
    • La Mesa, California, United States, 91942
      • Velocity Clin Res San Diego
    • La Mesa, California, United States, 91942
      • Diabetes & Endocrine Specialists - La Mesa
    • Lincoln, California, United States, 95648
      • Clinical Trials Research
    • Loma Linda, California, United States, 92354
      • Loma Linda Univ Hlth Cr Endo
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Palm Springs, California, United States, 92262
      • Desert Oasis Healthcare
    • Panorama City, California, United States, 91402
      • Velocity Clin Res - Panorama
    • Pomona, California, United States, 91766
      • Western University of Health Sciences
    • San Jose, California, United States, 95148
      • Endocrinology Josel Cabaccan
    • San Mateo, California, United States, 94401
      • Mills-Peninsula Medical Center
    • San Ramon, California, United States, 94583
      • NorCal Endocrinology and Internal Medicine
    • Toluca Lake, California, United States, 91602
      • Premier Medical Center, Inc.
    • Van Nuys, California, United States, 91405
      • Velocity Clin Res - Panorama
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Colorado Springs, Colorado, United States, 80906
      • Optumcare Clinical Trials,LLC-Golden
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Northeast Res Inst. Inc.
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33155
      • Bioclinical Research Alliance
    • Miramar, Florida, United States, 33027
      • South Broward Research LLC
    • Ocoee, Florida, United States, 34761
      • West Orange Endocrinology
    • Orange City, Florida, United States, 32763
      • Optimal Research Sites
    • Orlando, Florida, United States, 32804
      • Trans Res Inst for Met & Diab
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research, LLC
    • Pembroke Pines, Florida, United States, 33024
      • Center for Diab,Obes & Metab
  • Georgia
    • Conyers, Georgia, United States, 30094
      • Hope Clin Res & Wellness
    • Gainesville, Georgia, United States, 30501
      • Center for Adv Res & Education
    • Marietta, Georgia, United States, 30067
      • Urban Family Practice Assoc
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Pacific Diabetes & Endo Ctr
  • Idaho
    • Boise, Idaho, United States, 83702
      • St. Luke's Health System
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar-Crosse Research Center
    • Gurnee, Illinois, United States, 60031
      • Clinical Invest Special_Gurnee
    • Skokie, Illinois, United States, 60077
      • Evanston Premier Hlthcr Res
    • Skokie, Illinois, United States, 60077
      • Endeavor Health
  • Indiana
    • Greenfield, Indiana, United States, 46140
      • American Health Network of Indiana, LLC_Greenfield
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Diabetes & Endo Res Ctr
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Diab & Endo Ctr
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clin Res Lafayette
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Hlth Res Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center
  • Mississippi
    • Belzoni, Mississippi, United States, 39038
      • Belzoni Clinical Research
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clin Res Gulfport
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Diabetes & Endo Specialists Inc
    • City of Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research LLC
    • St Louis, Missouri, United States, 63128
      • Amicis Centers of Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87107
      • Velocity Clin Res Albuquerque
  • New York
    • Albany, New York, United States, 12203
      • AMC Community Endocrinology
    • East Syracuse, New York, United States, 13057
      • Velocity Clin Res Syracuse
    • West Seneca, New York, United States, 14224
      • Southgate Medical Group, LLP
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Eastowne Clinical Research Unit
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest Life Sciences LLC
    • Morehead City, North Carolina, United States, 28557
      • Carteret Medical Group
    • Morehead City, North Carolina, United States, 28557
      • Centricity Rsrch MHCity Multi
    • Statesville, North Carolina, United States, 28625
      • Piedmont Healthcare/Research
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Clinical Research Center, LLC
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Remington Davis Inc
    • Maumee, Ohio, United States, 43537
      • Advanced Medical Research
    • Wadsworth, Ohio, United States, 44281-9236
      • New Venture Medical Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Lynn Institute of Norman
  • Pennsylvania
    • Horsham, Pennsylvania, United States, 19044
      • CCT Research
    • Philadelphia, Pennsylvania, United States, 19114
      • Thomas Jefferson University_Philadelphia
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Clinical Res Collaborative
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clin Res Providence
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Velocity Clinical Res-Anderson
    • Myrtle Beach, South Carolina, United States, 29572
      • Trial Management Associates
    • Simpsonville, South Carolina, United States, 29681-1538
      • Hillcrest Clinical Research
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes And Endocrinology Center
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group Pc
    • Chattanooga, Tennessee, United States, 37411
      • Univ Diab & Endo Consultants
    • Jackson, Tennessee, United States, 38305
      • Jackson Clinic
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions
    • Morristown, Tennessee, United States, 37813
      • HealthStar Physicians PC
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates
  • Texas
    • Arlington, Texas, United States, 76012-4637
      • Arlington Family Res. Ctr Inc
    • Austin, Texas, United States, 78759
      • Velocity Clin Res
    • Bellaire, Texas, United States, 77401
      • UT Health University of Texas
    • Dallas, Texas, United States, 75231
      • North Texas Endocrine Center
    • Dallas, Texas, United States, 75251
      • Cedar Health Research
    • Dallas, Texas, United States, 75230
      • Velocity Clin Res, Dallas
    • Dallas, Texas, United States, 75234
      • Synexus Clin Res Dallas
    • Houston, Texas, United States, 77089
      • Amir Ali Hassan, MD, PA
    • Houston, Texas, United States, 77024
      • PrimeCare Medical Group
    • Houston, Texas, United States, 77079
      • PlanIt Research, PLLC
    • Houston, Texas, United States, 77061
      • Discovery MM Services, Inc
    • Houston, Texas, United States, 77040
      • JCCT- Juno NW Houston
    • Lampasas, Texas, United States, 76550
      • Fmc Science, Llc
    • San Antonio, Texas, United States, 78229
      • University of Texas San Antonio
    • San Antonio, Texas, United States, 78233
      • NE Clin Res of San Antonio
    • San Antonio, Texas, United States, 78209
      • Quality Clinical Research, Inc.
    • San Antonio, Texas, United States, 78284
      • University of Texas San Antonio
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
    • Sugar Land, Texas, United States, 77478
      • Mt Olympus Medical Research, LLC
    • Tomball, Texas, United States, 77375
      • DM Clin Rsrch/Fam Diag Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • Foothill Family Clinic South
    • South Jordan, Utah, United States, 84095
      • J.Lewis Research Inc
    • West Jordan, Utah, United States, 84088
      • Velocity Clin Res-Salt Lk City
  • Virginia
    • Newport News, Virginia, United States, 23606
      • TPMG Clinical Research
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clin Res Ctr Inc
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54303
      • Prevea Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CagriSema; Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.	Drug: Cagrilintide; Cagrilintide will be administered subcutaneously.; Drug: Semaglutide; Semaglutide will be administered subcutaneously.
Active Comparator: Tirzepatide; Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.	Drug: Tirzepatide; Tirzepatide will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 68)
Change in glycated haemoglobin (HbA1c)	Measured in percentage (%)-points.	From baseline (week 0) to end of treatment (week 68)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 68)
Change in HbA1c	Measured in %-points.	From baseline (week 0) to end of treatment (week 68)
Change in fasting plasma glucose (FPG)	Measured in millimoles per liter (mmol/L).	From baseline (week 0) to end of treatment (week 68)
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])	Count of participant	At end of treatment (week 68)
Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)	Count of participant	From baseline (week 0) to end of treatment (week 68)
Achievement of greater than or equal to (≥) 5% weight reduction	Count of participant	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥ 10% weight reduction	Count of participant	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥ 15 % weight reduction	Count of participant	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥ 20 % weight reduction	Count of participant	From baseline (week 0) to end of treatment (week 68)
Change in systolic blood pressure	Measured in millimeters of mercury(mmHg).	From baseline (week 0) to end of treatment (week 68)
Change in diastolic blood pressure	Measured in mmHg.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Total cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Triglycerides	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: non-HDL cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey	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.	From baseline (week 0) to end of treatment (week 68)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3	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.	From baseline (week 0) to end of treatment (week 68)
Number of Treatment-emergent Adverse Events (TEAEs)	Count of events	From baseline (week 0) to end of study (week 74)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter)	Count of episodes	From baseline (week 0) to end of study (week 74)
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold	Count of episodes	From baseline (week 0) to end of study (week 74)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Actual): March 4, 2026
• Study Completion (Actual): April 6, 2026

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide; semaglutide; cagrilintide
• Other Study ID Numbers: NN9388-4894; U1111-1282-5561 (Other Identifier: World Health Organization (WHO)); 2023-503789-21-00 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No