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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221969
• Other study ID #: NN9388-4894
• Secondary ID: U1111-1282-55612
• Status: Recruiting
• Phase: Phase 3
• Start date: January 16, 2024
• Est. completion date: December 23, 2025

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 23, 2025
• Est. primary completion date: November 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female.
• 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 a fundus 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Cagrilintide
Cagrilintide will be administered subcutaneously.
• Semaglutide
Semaglutide will be administered subcutaneously.
• Tirzepatide
Tirzepatide will be administered subcutaneously.

Locations

Country	Name	City	State
Argentina	Instituto de Investigaciones Metabolicas (IDIM)	Buenos Aires
Argentina	Centro de Investigación Clínica	Caba
Argentina	Centro de Investigación Clínica	Caba
Argentina	Buenos Aires Mácula	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	CICEMO- Consultorio de Investigación Clínica EMO	Ciudad Autonoma de Buenos Aires
Argentina	CICEMO- Consultorio de Investigación Clínica EMO	Ciudad Autonoma de Buenos Aires
Argentina	OMI- Organización Médica de Investigación	Ciudad Autonoma de Buenos Aires
Argentina	Instituto Medico Especializado_Capital Federal	Ciudad de Buenos Aires	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas	Mar del Plata
Argentina	CEDIR - Centro de diagnóstico y rehabilitación Santa Fe	Santa Fe
Australia	Paratus Clinical	Blacktown	New South Wales
Australia	Townsville University Hospital	Douglas	Queensland
Australia	Paratus Clinical	Kanwal	New South Wales
Australia	Hunter Diabetes Centre	Merewether	New South Wales
Australia	University of Sunshine Coast	Morayfield	Queensland
Australia	Southern Adelaide Diabetes & Endocrine Services	Oaklands Park	South Australia
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Austrials	St Albans	Victoria
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Austrials	Taringa	Queensland
Canada	Centricity Research Oshawa	Barrie	West Oshawa
Canada	Centricity Research Brampton	Brampton	Ontario
Canada	Centricity Research Calgary	Calgary	Alberta
Canada	Milestone Research	London	Ontario
Canada	Western Univ. Cnt for Studies in Fam Med	London	Ontario
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	Centre Medical Acadie	Montreal	Quebec
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Clin des Mal Lipid de Quebec	Quebec
Canada	ALPHA Recherche Clinique	Quebec City	Quebec
Canada	London Road Diagnostic Clinic and Medical Centre	Sarnia	Ontario
Canada	Guilford Med Clinic	Surrey	British Columbia
Canada	Hilltop Medical Clinic	Surrey	British Columbia
Canada	Ocean West Research Clinic	Surrey	British Columbia
Canada	TLC Diabetes and Endocrinology	Surrey	British Columbia
Canada	Ctr de Med Metab de Lanaudiere	Terrebonne	Quebec
Canada	Centricity Research Toronto	Toronto	Ontario
Canada	Diabetes Heart Research Centre	Toronto	Ontario
Canada	Diex Recherche Victoriaville	Victoriaville	Quebec
Colombia	Cimedical	Barranquilla
Colombia	Clinica de la Costa	Barranquilla
Colombia	Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S.	Bogotá
Colombia	UNIENDO	Bogotá
Colombia	FOSCAL	Floridablanca	Santander
Czechia	LESTELA HLUCÍN, s.r.o.	Hlucín
Czechia	Fakultní nemocnice Hradec Králové	Hradec Kralove
Czechia	Diabetologické centrum s.r.o.	Olomouc
Czechia	Fakultní nemocnice Královské Vinohrady	Praha 10
Czechia	Fledip s.r.o.	Praha 6
Czechia	Intendia s.r.o.	Trutnov
Czechia	Interní a diabetologická ordinace	Valašské Klobouky
France	Gie Groupe Hospitalier Paris Saint-Joseph/Vinci	Paris
France	Centre Hospitalier de Perigueux	Périgueux
France	Hospices Civils de Lyon-Hopital Lyon Sud-1	Pierre Benite
France	Hopital Novo	Pontoise
France	Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre-1	Strasbourg
France	Groupe Hospitalier Mutualiste Des Portes Du Sud	Venissieux
France	RESEAU DE SANTE MUTUALISTE-Médipôle Hôpital Mutualiste	Villeurbanne
Germany	Klinik für Endokrinologie, Diabetologie und Stoffwechsel	Essen
Germany	Praxis am Markt Dr. Becker	Essen
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Uniklinik Heidelberg Innere Medizin I	Heidelberg
Germany	Diabeteszentrum München Süd	München
Germany	Medicover Neuroendokrinologie MVZ	München
Germany	Institut für Diabetesforschung GmbH Münster - Dr. med. Rose	Münster
Germany	MedicalCenter am Clemenshospital	Münster
Germany	Institut für Diabetesforschung Osnabrück	Osnabrück
Germany	Zentrum für klinische Studien Allgäu Oberschwaben	Wangen
Greece	"Laiko" General Hospital of Athens	Athens
Greece	Iatriko Athinon 'Palaiou Falirou'	Athens
Greece	University Hospital of Athens ATTIKON	Haidari-Athens
Greece	"Thermi" Private Hosital	Thessaloniki
Hungary	MH Egészségügyi Központ	Budapest
Hungary	Óbudai Egészségügyi Centrum	Budapest
Hungary	Kaposi Mór Oktató Kórház	Kaposvár
Hungary	Zala Megyei Szent Rafael Kórház	Zalaegerszeg
India	Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University	Aligarh
India	Belgaum Diabetes Centre	Belgaum	Karnataka
India	SRM Centre for Clinical Trials & Research	Chennai
India	Maulana Azad Medical College	Delhi	New Delhi
India	AIG Hospitals,Hyderabad	Hyderabad	Telangana
India	Diabetes, Thyroid and Endocrine Centre	Jaipur	Rajasthan
India	SMS Medical College & Hospital	Jaipur	Rajasthan
India	BP Poddar Hospital	Kolkata,	West Bengal
India	Government Medical College, Kozhikode	Kozhikode	Kerala
India	BSES MG hospital	Mumbai	Maharashtra
India	Seth GS Medical College & KEM Hospital	Mumbai	Maharashtra
India	Government Institute of Medical Sciences	Noida	Uttar Pradesh
India	Chellaram Diabetes Institute	Pune	Maharashtra
India	Grant Medical Foundation Ruby Hall Clinic	Pune	Maharashtra
India	Nirmal Hospital Pvt. Ltd.	Surat
India	Indian Institute of Diabetes	Thiruvnanthapuram	Kerela
India	Jothydev's Diabetes & Research Center	Thriruvananthapuram
India	SSG Hospital, Baroda	Vadodara	Gujarat
India	Christian Medical College Hospital, Vellore	Vellore	Tamil Nadu
Poland	Osteo-Medic s.c. A. Racewicz, J. Supronik	Bialystok
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie Voivodeship
Poland	Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski	Gorzow Wielkopolski	Lubuskie
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	Gabinet Lekarski Malgorzata Saryusz-Wolska	Lodz
Poland	Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Malopolskie
Poland	NBR Polska	Warszawa	Mazowieckie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko	Zabrze
Romania	Minimed S.R.L.	Bacau
Romania	Mariodiab Clinic SRL	Brasov
Romania	Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila	Bucharest	Bucurestii
Romania	Hightech Medical Services S.R.L.	Bucuresti
Romania	Spitalul Clinic Judetean Urgenta Cluj-Napoca	Cluj Napoca	Cluj
Romania	SC Consultmed SRL	Iasi
Romania	Diabdana S.R.L.	Oradea	Bihor
Romania	Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara	Timisoara
South Africa	Dr Wilhase's rooms	Boksburg	Gauteng
South Africa	Bella Vita Clinical Research	Cape Town	Western Cape
South Africa	Dr J Reddy	Durban	KwaZulu-Natal
South Africa	Synapta Clinical Research Centre	Durban	KwaZulu-Natal
South Africa	Ubuntu Clinical Research	Johannesburg	Gauteng
South Africa	Krugersdorp Medical Centre	Krugersdorp	Gauteng
Spain	Hospital Fundación Alcorcón	Alcorcón	Madrid
Spain	Centro Periferico De Especialidades Bola Azul	Almeria	Almería
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital General Universitario de Toledo	Toledo
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Chung Shan Medical University Hospital	Taichung City
Taiwan	Kuang Tien General Hospital	Taichung City
Taiwan	Taichung Veterans General Hospital	Taichung City
Taiwan	National Cheng Kung University Hospital	Tainan City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Albany Medical College - Endo	Albany	New York
United States	Velocity Clin Res Albuquerque	Albuquerque	New Mexico
United States	Velocity Clinical Res-Anderson	Anderson	South Carolina
United States	Arlington Family Res. Ctr Inc	Arlington	Texas
United States	University of Colorado Hospital	Aurora	Colorado
United States	Velocity Clin Res	Austin	Texas
United States	AM Diabetes And Endocrinology Center	Bartlett	Tennessee
United States	UT Health University of Texas	Bellaire	Texas
United States	Belzoni Clinical Research	Belzoni	Mississippi
United States	Belzoni Clinical Research	Belzoni	Mississippi
United States	Synexus Clin Res-Birmingham	Birmingham	Alabama
United States	Univ of Alabama_Birmingham	Birmingham	Alabama
United States	St. Luke's Health System	Boise	Idaho
United States	Joslin Center For Diabetes	Boston	Massachusetts
United States	Holston Medical Group Pc	Bristol	Tennessee
United States	UNC Eastowne Clinical Research Unit	Chapel Hill	North Carolina
United States	Univ Diab & Endo Consultants	Chattanooga	Tennessee
United States	Diabetes & Endo Specialists Inc	Chesterfield	Missouri
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Velocity Clin Res-Chula Vista	Chula Vista	California
United States	Optumcare Colorado Springs	Colorado Springs	Colorado
United States	Remington Davis Inc	Columbus	Ohio
United States	Hope Clin Res & Wellness	Conyers	Georgia
United States	Clinical Res Collaborative	Cumberland	Rhode Island
United States	Cedar Health Research	Dallas	Texas
United States	North Texas Endocrine Center	Dallas	Texas
United States	North Texas Endocrine Center	Dallas	Texas
United States	Synexus Clin Res Dallas	Dallas	Texas
United States	Velocity Clin Res, Dallas	Dallas	Texas
United States	Velocity Clin Res Providence	East Greenwich	Rhode Island
United States	Velocity Clin Res Syracuse	East Syracuse	New York
United States	Headlands Research California, LLC	Escondido	California
United States	Neighborhood Healthcare	Escondido	California
United States	Plains Clinical Research Center, LLC	Fargo	North Dakota
United States	St. Jude Heritage Yorba Linda - Pediatric Ste D	Fullerton	California
United States	Center for Adv Res & Education	Gainesville	Georgia
United States	Center for Adv Res & Education	Gainesville	Georgia
United States	Prime Medical Group, LLC	Gilbert	Arizona
United States	Prevea Health	Green Bay	Wisconsin
United States	American Health Network of Indiana, LLC_Greenfield	Greenfield	Indiana
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	Velocity Clin Res Gulfport	Gulfport	Mississippi
United States	Clinical Invest Special_Gurnee	Gurnee	Illinois
United States	CCT Research	Hatboro	Pennsylvania
United States	Pacific Diabetes & Endo Ctr	Honolulu	Hawaii
United States	Amir Ali Hassan, MD, PA	Houston	Texas
United States	Discovery MM Services, Inc	Houston	Texas
United States	Juno Research, LLC_Houston	Houston	Texas
United States	PlanIt Research, PLLC	Houston	Texas
United States	PrimeCare Medical Group	Houston	Texas
United States	MedStar Hlth Res Institute	Hyattsville	Maryland
United States	Jackson Clinic	Jackson	Tennessee
United States	Northeast Res Inst. Inc.	Jacksonville	Florida
United States	Holston Medical Group	Kingsport	Tennessee
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	Velocity Clin Res Lafayette	Lafayette	Louisiana
United States	Fmc Science, Llc	Lampasas	Texas
United States	Clinical Trials Research	Lincoln	California
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	Loma Linda Univ Hlth Cr Endo	Loma Linda	California
United States	Urban Family Practice Assoc	Marietta	Georgia
United States	Advanced Medical Research	Maumee	Ohio
United States	Clinical Neuroscience Solutions	Memphis	Tennessee
United States	Solaris Clinical Research	Meridian	Idaho
United States	Bioclinical Research Alliance	Miami	Florida
United States	Clinical Trial Services Corp	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	International Diabetes Center	Minneapolis	Minnesota
United States	South Broward Research LLC	Miramar	Florida
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Lucas Research Inc.	Morehead City	North Carolina
United States	HealthStar Physicians PC	Morristown	Tennessee
United States	Trial Management Associates	Myrtle Beach	South Carolina
United States	Clinical Research Associates	Nashville	Tennessee
United States	Clinical Research Associates	Nashville	Tennessee
United States	TPMG Clinical Research	Newport News	Virginia
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	West Orange Endocrinology	Ocoee	Florida
United States	Optimal Research Sites	Orange City	Florida
United States	Trans Res Inst for Met & Diab	Orlando	Florida
United States	Oviedo Medical Research, LLC	Oviedo	Florida
United States	Desert Oasis Healthcare	Palm Springs	California
United States	Velocity Clin Res - Panorama	Panorama City	California
United States	Velocity Clin Res - Panorama	Panorama City	California
United States	Thomas Jefferson University_Philadelphia	Philadelphia	Pennsylvania
United States	Synexus Cln Rsrch /Cnt Phoenix Med C	Phoenix	Arizona
United States	Velocity Clinical Research-Phoenix	Phoenix	Arizona
United States	Western University of Health Sciences	Pomona	California
United States	Rainier Clin Res Ctr Inc	Renton	Washington
United States	Endocrine Research Solutions	Roswell	Georgia
United States	Amicis Centers of Clinical Research	Saint Louis	Missouri
United States	StudyMetrix Research LLC	Saint Peters	Missouri
United States	Foothill Family Clinic South	Salt Lake City	Utah
United States	NE Clin Res of San Antonio	San Antonio	Texas
United States	Quality Clinical Research, Inc.	San Antonio	Texas
United States	University of Texas San Antonio	San Antonio	Texas
United States	Endocrinology Josel Cabaccan	San Jose	California
United States	Mills-Peninsula Medical Center	San Mateo	California
United States	Mills-Peninsula Medical Center	San Mateo	California
United States	NorCal Endocrinology and Internal Medicine	San Ramon	California
United States	Unity Health-Searcy Medical Center	Searcy	Arkansas
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Hillcrest Clinical Research	Simpsonville	South Carolina
United States	Evanston Premier Hlthcr Res	Skokie	Illinois
United States	NorthShore Univ Hlth Sys	Skokie	Illinois
United States	J.Lewis Research Inc	South Jordan	Utah
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Piedmont Healthcare/Research	Statesville	North Carolina
United States	Mt Olympus Medical Research, LLC	Sugar Land	Texas
United States	Premier Medical Center, Inc.	Toluca Lake	California
United States	DM Clin Rsrch/Fam Diag Clinic	Tomball	Texas
United States	Cotton-O'Neil Diab & Endo Ctr	Topeka	Kansas
United States	New Venture Medical Research	Wadsworth	Ohio
United States	New Venture Medical Research	Wadsworth	Ohio
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Iowa Diabetes & Endo Res Ctr	West Des Moines	Iowa
United States	Velocity Clin Res-Salt Lk City	West Jordan	Utah
United States	Southgate Medical Group, LLP	West Seneca	New York
United States	Accellacare	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Colombia,  Czechia,  France,  Germany,  Greece,  Hungary,  India,  Poland,  Romania,  South Africa,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycated haemoglobin (HbA1c)	Measured in percentage (%)-points.	From baseline (week 0) to end of treatment (week 68)
Primary	Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in HbA1c	Measured in %-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in fasting plasma glucose (FPG)	Measured in millimoles per liter (mmol/L).	From baseline (week 0) to end of treatment (week 68)
Secondary	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)
Secondary	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)
Secondary	Achievement of greater than or equal to (=) 5% weight reduction	Count of participant	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of = 10% weight reduction	Count of participant	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of = 15 % weight reduction	Count of participant	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of = 20 % weight reduction	Count of participant	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in systolic blood pressure	Measured in millimeters of mercury(mmHg).	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in diastolic blood pressure	Measured in mmHg.	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: Total cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: Triglycerides	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: non-HDL cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	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)
Secondary	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)
Secondary	Number of Treatment-emergent Adverse Events (TEAEs)	Count of events	From baseline (week 0) to end of study (week 74)
Secondary	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)
Secondary	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)