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 (REIMAGINE 5)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1023
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • City of Buenos Aires, Argentina, C1056ABH
    • IMOBA
  • City of Buenos Aires, Argentina, C1056ABI
    • Centro de Investigaciones Metabólicas
  • San Nicolás, Argentina, B2900
    • Instituto de Investigaciones Clinicas San Nicolás
  • Buenos Aires
    • Lanús Este, Buenos Aires, Argentina, B1824KAJ
      • Centro Médico CIMEL
    • Mar del Plata, Buenos Aires, Argentina, B7600GNY
      • Centro de Investigaciones Medicas Mar del Plata
  • La Pampa Province
    • Santa Rosa, La Pampa Province, Argentina, 6300
      • Fundación CESIM
  • Tucumán Province
    • San Miguel de Tucuimán, Tucumán Province, Argentina, 4000
      • Centro de Investigaciones Médicas Tucuman
• Australia
  • Australian Capital Territory
    • Bruce, Australian Capital Territory, Australia, 2617
      • Paratus Clinical
  • New South Wales
    • Merewether, New South Wales, Australia, 2291
      • Hunter Diabetes Centre
    • St Leonards, New South Wales, Australia, 2065
      • Austrials
    • St Leonards, New South Wales, Australia, 2065
      • Momentum Clinical Research St Leonards
    • Sydney, New South Wales, Australia, 2148
      • Roger Chih Yu Chen
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • Townsville University Hospital
    • Herston, Queensland, Australia, 4006
      • Paratus Clinical
• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 80810-040
      • Centro de Diabetes Curitiba
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
      • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01228-000
      • CPQuali Pesquisa Clinica Ltda
• Canada
  • Québec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • British Columbia
    • Surrey, British Columbia, Canada, V4A 0C1
      • Hilltop Medical Clinic
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • G.A. Research Associates Ltd.
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Centricity Research Brampton Endocrinology
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Centricity Research Etobicoke Endocrinology
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Medical Clinic Clinical Trials (Hamilton)
    • Sarnia, Ontario, Canada, N7T 4X3
      • London Road Diagnostic Clinic and Medical Centre
    • Toronto, Ontario, Canada, M6G 1M2
      • Diabetes Heart Research Centre
  • Quebec
    • Laval, Quebec, Canada, H7T 2P5
      • Ctr de recherche Clinique de Laval
    • Lévis, Quebec, Canada, G6V 0C9
      • Alpha Recherche Clinique - Clinique de Levis
    • Montreal, Quebec, Canada, H4N 2W2
      • Centre Medical Acadie
    • Terrebonne, Quebec, Canada, J6X 4P7
      • Ctr de méd métab de Lanaudière
    • Victoriaville, Quebec, Canada, G6P 3Z8
      • Diex Recherche Victoriaville
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
  • Essen, Germany, 45355
    • Praxis am Markt Dr. Becker
  • Essen, Germany, 45147
    • Universitätsklinikum Essen - Klinik für Endokrinologie, Diabetologie und Stoffwechsel
  • Freiburg im Breisgau, Germany, 79106
    • Universitätsklinikum Freiburg - Innere Medizin II
  • Hamburg, Germany, 22607
    • Wendisch - Dahl Hamburg - DZHW
  • München, Germany, 81667
    • Medicover Neuroendokrinologie MVZ München
  • Münster, Germany, 48153
    • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
  • Wangen, Germany, 88239
    • Zentrum für klinische Studien Allgäu Oberschwaben
• Greece
  • Athens, Greece, 10676
    • Evangelismos Hospital
  • Athens, Greece, 17562
    • Iatriko Athinon 'Palaiou Falirou'
  • Goudi/Athens, Greece, 11527
    • "Laiko" General Hospital of Athens
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina,Internal Medicine
  • Thessaloniki, Greece, 54642
    • 'Ippokrateio' General Hospital of Thessaloniki
  • Thessaloniki, Greece, 54635
    • General Hospital of Thessaloniki 'G. Gennimatas
  • Attica
    • Athens, Attica, Greece, 11528
      • Alexandra General Hospital, Therapeutic Clinic
  • Crete
    • Heraklion, Crete, Greece, 71409
      • General Hospital Venizeleio-Pananeio - Diabetic Clinic
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, 1042
    • Szőcs Depot Egészségügyi Szolgáltató Kft.
  • Budapest, Hungary, 1089
    • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
  • Budapest, Hungary, 1132
    • MED-TIMA Kft.
  • Budapest, Hungary, 1102
    • PVN Kutató Kft.
  • Budapest, Hungary, 1134
    • Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés
  • Csongrád-Csanád
    • Szeged, Csongrád-Csanád, Hungary, 6725
      • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
  • Komárom-Esztergom
    • Komárom, Komárom-Esztergom, Hungary, 2900
      • Komaromi Selye Janos Korhaz
  • Pest County
    • Budapest, Pest County, Hungary, 1036
      • Óbudai Egészségügyi Centrum
    • Budapest, Pest County, Hungary, 1134
      • QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft
• India
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Endolife Specialty Hospitals
  • Karnataka
    • Bengaluru, Karnataka, India, 560054
      • Ramaiah Memorial Hospital
  • Maharashtra
    • Kolhāpur, Maharashtra, India, 416008
      • Excel Endocrine Centre
    • Wardha, Maharashtra, India, 442001
      • Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110029
      • All India Institute of Medical Sciences (AIIMS)
  • Rajasthan
    • Ajmer, Rajasthan, India, 305001
      • Jawahar Lal Nehru Govt. Medical College
    • Jaipur, Rajasthan, India, 302004
      • SMS Hospital
    • Jaipur, Rajasthan, India, 302006
      • Diabetes, Thyroid and Endocrine Centre
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625 020
      • Arthur Asirvatham hospital,
    • Puducherry, Tamil Nadu, India, 605006
      • Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • AIG Hospitals,Hyderabad
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226002
      • Udyaan Health Care
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • IPGME&R and SSKM Hospital
• Israel
  • Haifa, Israel, 31096
    • Rambam MC - Diabetes and obesity center of excellence
  • Holon, Israel, 58100
    • Wolfson MC - Diabetes Clinic
  • Jerusalem, Israel, 91120
    • Hadassah Ein Karam MC - Diabetes Unit
  • Petah Tikva, Israel, 49100
    • Rabin MC Beilinson - Endo unit
  • Tel Aviv, Israel, 6423906
    • Sourasky MC - Institute of Endocrinology, metabolism and hypertension
  • Tel Litwinsky, Israel, 52621
    • Sheba MC - Endocrinology Clinic
  • Israel
    • Herzeliya, Israel, Israel, 4630945
      • Clalit sick fund Herzeliya
• Poland
  • Bialystok, Poland, 15-269
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Chorzów, Poland, 41-516
    • Diab Serwis Popenda Spółka Jawna
  • Gorzów Wielkopolski, Poland, 66-400
    • Specjalistyczny Gabinet Diabetologiczny Rumianowski Radosław
  • Olsztyn, Poland, 10-117
    • Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
  • Sosnowiec, Poland, 41-209
    • Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
  • Zabrze, Poland, 41-800
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-276
      • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-338
      • Centrum Terapii Wspolczesnej - J.M. Jasnorzewska S.K.A.
• Romania
  • Bucharest, Romania, 013764
    • SC Nutrilife SRL
  • Bucharest, Romania, 050913
    • Diabet Med SRL
  • Bucharest, Romania, 060013
    • Sanamed Hospital SRL
  • Satu Mare, Romania, 440055
    • Clinica Korall S.R.L. Satu Mare
  • Bihor County
    • Oradea, Bihor County, Romania, 410147
      • Diabdana S.R.L.
  • Bucharest
    • Bucharest, Bucharest, Romania, 020475
      • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
  • Maramureş
    • Baia Mare, Maramureş, Romania, 430222
      • CMI Dr Pop Lavinia
  • Mureș County
    • Târgu Mureş, Mureș County, Romania, 540142
      • Sc Mediab Srl
• Spain
  • Almería, Spain, 04009
    • Centro Periferico de Especialidades Bola Azul
  • Barcelona, Spain, 08035
    • Hospital Vall d'hebrón
  • Granada, Spain, 18016
    • Hospital Universitario San Cecilio
  • Seville, Spain, 41003
    • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  • Valladolid, Spain, 47003
    • Hospital Clínico de Valladolid
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universitaria de Navarra
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 833
    • Chang Gung Memorial Hospital - Kaohsiung Branch
  • Kaoshiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 404328
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital, Linkou
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital Linkou
• United States
  • Alabama
    • Pelham, Alabama, United States, 35124
      • Cahaba Research
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Velocity Clinical Research-Phoenix
    • Tucson, Arizona, United States, 85712
      • AES Tucson DRS
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland Int. Research Group
  • California
    • Chula Vista, California, United States, 91911
      • Velocity Clin Res-Chula Vista
    • Concord, California, United States, 94520
      • John Muir Physicians Network
    • La Mesa, California, United States, 91942
      • Diabetes & Endocrine Specialists - La Mesa
    • Los Angeles, California, United States, 90017
      • Velocity Clin Research LA
    • Palm Springs, California, United States, 92262
      • Desert Oasis Healthcare
    • Santa Ana, California, United States, 92704
      • Velocity Clin Res Santa Ana
    • Van Nuys, California, United States, 91405
      • Velocity Clin Res - Panorama
  • Colorado
    • Colorado Springs, Colorado, United States, 80906
      • Optumcare Clinical Trials,LLC-Golden
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • FEME Medical LLC
  • Florida
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Hialeah, Florida, United States, 33012
      • AGA Clinical Trial
    • 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
    • Pembroke Pines, Florida, United States, 33024
      • Center for Diab,Obes & Metab
  • Georgia
    • Fayetteville, Georgia, United States, 30214
      • Javara Inc. / Privia Medical Group Georgia LLC
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Clinical Invest Special_Gurnee
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Diabetes & Endo Res Ctr
  • Kansas
    • Topeka, Kansas, United States, 66606-2806
      • Cotton-Oneill Diabetes and End
  • Minnesota
    • Richfield, Minnesota, United States, 55423
      • AES Minneapolis DRS
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clin Res Gulfport
  • Missouri
    • St Louis, Missouri, United States, 63141
      • AES St. Louis DRS
  • Nebraska
    • Omaha, Nebraska, United States, 68198-3020
      • Univ of Nebraska Medical CTR
  • New Mexico
    • Albuquerque, New Mexico, United States, 87107
      • Velocity Clin Res Albuquerque
  • New York
    • Albany, New York, United States, 12203
      • Albany Medical College
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Carteret Medical Group
    • Statesville, North Carolina, United States, 28625
      • Piedmont Healthcare/Research
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research LLC
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Triad Research Institute
  • Pennsylvania
    • Pottstown, Pennsylvania, United States, 19464
      • Circuit Clinical - PMSI
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Clinical Res Collaborative
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clin Res Providence
  • South Carolina
    • Gaffney, South Carolina, United States, 29340
      • Velocity Clin Res Gaffney
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates
  • Texas
    • Austin, Texas, United States, 78759
      • Velocity Clin Res Austin
    • Dallas, Texas, United States, 75390
      • UT Southwestern Med Center
    • Dallas, Texas, United States, 75234
      • Synexus Clin Res Dallas
    • Houston, Texas, United States, 77079
      • PlanIt Research, PLLC
    • Houston, Texas, United States, 77061
      • Synergy Groups Medical
    • Houston, Texas, United States, 77040
      • JCCT- Juno NW Houston
    • Kerrville, Texas, United States, 78028
      • Sante Clinical Research
    • Laredo, Texas, United States, 78041
      • Aeres Clinical Research
    • McAllen, Texas, United States, 78503
      • Biopharma Informatic, LLC
    • Stephenville, Texas, United States, 76401
      • Privia Health Javara Clin Res.
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • J.Lewis Research Inc
    • St. George, Utah, United States, 84790
      • Chrysalis Clinical Research
  • Virginia
    • Newport News, Virginia, United States, 23606
      • TPMG Clinical Research

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 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.

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 once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.	Drug: Cagrilintide; Participants will receive once-weekly cagrilintide subcutaneously.; Drug: Semaglutide; Participants will receive once-weekly semaglutide subcutaneously.
Experimental: Tirzepatide; Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks.	Drug: Tirzepatide; Participants will receive once-weekly tirzepatide subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Haemoglobin (HbA1c)	Measured in percentage points.	From baseline (week 0) to end of treatment (week 60)
Relative Change in Body Weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 60)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Measured in percentage points.	From baseline (week 0) to end of treatment (week 60)
Change in Fasting Plasma Glucose (FPG)	Measured as millimole per liter (mmol/L).	From baseline (week 0) to end of treatment (week 60)
Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol])	Measured as count of participants.	At end of treatment (week 60)
Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol)	Measured as count of participants.	At end of treatment (week 60)
Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 60)
Number of Participants Who Achieve >= 10% Weight Reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 60)
Number of Participants Who Achieve >= 15% Weight Reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 60)
Number of Participants Who Achieve >= 20% Weight Reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 60)
Change in Systolic Blood Pressure (SBP)	Measured in millimeter of mercury (mmHg).	From baseline (week 0) to end of treatment (week 60)
Change in Diastolic Blood Pressure (DBP)	Measured in mmHg.	From baseline (week 0) to end of treatment (week 60)
Change in Waist Circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 60)
Ratio to Baseline in Lipids: Total Cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 60)
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 60)
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 60)
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 60)
Ratio to Baseline in Lipids: Triglycerides	Measured as ratio.	From baseline (week 0) to end of treatment (week 60)
Ratio to Baseline in Lipids: Non-HDL cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 60)
Change in Short Form (SF) -36v2 Score: Physical Component Summary Score	Measured as score points. 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 US general population has a mean of 50 and a standard deviation of 10. Physical component summary scores ranges from 6.1 to 79.7 with higher scores indicating better functional health and well-being.	From baseline (week 0) to end of treatment (week 60)
Change in SF-36v2 Score: Mental Component Summary Score	Measured as score points. 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 US general population has a mean of 50 and a standard deviation of 10. Mental component summary scores ranges from -3.8 to 78.7 with higher scores indicating better functional health and well-being.	From baseline (week 0) to end of treatment (week 60)
Change in SF-36v2 Score: Vitality Subscale	Measured as score points. 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 US general population has a mean of 50 and a standard deviation of 10. Vitality score ranges from 25.6 to 69.1 with higher scores indicating better functional health and well-being.	From baseline (week 0) to end of treatment (week 60)
Change in Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQOL-Lite-CT) : Physical Function score	Measured as score points. 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. Physical functioning score ranges from 0 to 100, with higher scores reflecting better levels of functioning.	From baseline (week 0) to end of treatment (week 60)
Change in IWQOL-Lite-CT: Total score	Measured as score points. 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. Total score ranges from 0 to 100, with higher scores reflecting better levels of functioning.	From baseline (week 0) to end of treatment (week 60)
Number of Treatment Emergent Adverse Events (TEAEs)	Measured as count of events.	From baseline (week 0) to end of study (week 66)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (<54 Milligram per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter	Measured as count of episodes.	From baseline (week 0) to end of study (week 66)
Number of Severe Hypoglycaemic Episodes (Level 3): Hypoglycaemia Associated With Severe Cognitive Impairment Requiring External Assistance for Recovery, With no Specific Glucose Threshold	Measured as count of episodes.	From baseline (week 0) to end of study (week 66)

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): November 5, 2024
• Primary Completion (Actual): June 2, 2026
• Study Completion (Actual): July 9, 2026

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 7, 2026
• Last Verified: September 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: NN9388-7741; 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation); U1111-1300-2590 (Other Identifier: World Health Organization (WHO)); 2023-509600-15 (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 novonordisktrials.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