Clinical trial NCT05394519: A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
Official title: Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Type 2 Diabetes Mellitus
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance.

The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age above or equal to 18 years at the time of signing informed consent
* BMI greather than or equal to 27.0 kg/m\^2
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
* Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
* Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
* HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening

Exclusion Criteria:

* Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
* Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening
* 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.

Primary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of greater than or equal to (≥) 5% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
Secondary outcomes:
measure: Achievement of ≥ 20% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Relative change in body weight
timeFrame: From baseline (week 0) to week 20
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in body mass index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Improvement in weight category (BMI, underweight below 18.5, normal weight 18.5 to below 25, overweight 25.0 to below 30, obesity class I 30 to below 35, obesity class II 35 to below 40, obesity class III above 40)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of HbA1c less than or equal to (≤) 6.5%
timeFrame: At end of treatment (week 68)
measure: Change in Fasting Plasma Glucose (mmol/L)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Fasting Plasma Glucose (mg/dL)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in fasting serum insulin
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in C-reactive protein (CRP)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides and Free fatty acids
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Control of Eating Questionnaire (CoEQ): Craving Control score, Positive Mood score, Craving for Sweet score, Craving for Savoury food score, Hunger score and Satiety score
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in IWQOL-Lite-CT Physical Function score
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Continuous glucose monitoring: Change in mean glucose (mmol/L)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Continuous glucose monitoring: Change in mean glucose (mg/L)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: CGM: Within-day glycaemic variability (% CV)
timeFrame: At end of treatment (week 68)
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to end of study (week 75)
measure: Number of Treatment Emergent Serious adverse events (TESAEs)
timeFrame: From baseline (week 0) to end of study (week 75)
measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)
timeFrame: From baseline (week 0) to end of study (week 75)
measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
timeFrame: From baseline (week 0) to end of study (week 75)
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physicians Network
state: California
city: Escondido
country: United States
facility: Headlands Research California, LLC
state: California
city: Fullerton
country: United States
facility: St. Jos Heritage Hlthcr_Fllrtn
state: California
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Mgmt & Res Ctr
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Los Angeles
country: United States
facility: Velocity Clin Res Los Angeles
state: California
city: Los Angeles
country: United States
facility: Velocity Clin Res Wstlke
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Hlthcr Med Group
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Golden
country: United States
facility: New West Physicians,Inc.
state: Colorado
city: Clearwater
country: United States
facility: Clinical Res Of W Florida Inc
state: Florida
city: Fleming Island
country: United States
facility: Northeast Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Ctr For Clin Res
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: AdventHealth Diab Inst
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research, LLC
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: Roswell
country: United States
facility: Endo Res Solutions Inc
state: Georgia
city: Honolulu
country: United States
facility: East West Med Res Inst
state: Hawaii
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diab & Endo Res Center
state: Iowa
city: Topeka
country: United States
facility: Cotton-Oneill Diabetes and End
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Pennington Biom Res Ctr
state: Louisiana
city: Buckley
country: United States
facility: Northern Pines Hlth Ctr, PC
state: Michigan
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Saint Peters
country: United States
facility: StudyMetrix Research LLC
state: Missouri
city: Butte
country: United States
facility: Mercury Str Med Grp, PLLC
state: Montana
city: Albany
country: United States
facility: Albany Medical College - Endo
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group, LLP
state: New York
city: Westfield
country: United States
facility: Great Lakes Medical Research
state: New York
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Med Spec LLP
state: Texas
city: Austin
country: United States
facility: Texas Diab & Endo, P.A.
state: Texas
city: Austin
country: United States
facility: Texas Diab & Endo, P.A.
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Med Cntr
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Longview
country: United States
facility: DCOL Ctr for Clin Res
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Richmond
country: United States
facility: National Clin Res Inc.
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Winchester
country: United States
facility: Amherst Family Practice P.C.
state: Virginia
city: Olympia
country: United States
facility: Capital Clin Res Ctr,LLC
state: Washington
city: Graz
country: Austria
facility: Universitätsklinik für Innere Medizin Graz
city: Saint Stefan
country: Austria
facility: Fließer-Görzer [Ordination]
city: Wien
country: Austria
facility: Klinik Landstraße
city: Wien
country: Austria
facility: Universitätsklinikum AKH Wien
city: Wien
country: Austria
facility: Imed 19- privat
city: Calgary
country: Canada
facility: LMC Clin Res Inc. Calgary
state: Alberta
city: Calgary
country: Canada
facility: C-endo Diab Endo Clin Calgery
state: Alberta
city: Victoria
country: Canada
facility: Dr. M.B. Jones Inc
state: British Columbia
city: Mount Pearl
country: Canada
facility: Commonwealth Medical Clinic
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: Dr. Harpreet Bajaj
state: Ontario
city: Etobicoke
country: Canada
facility: Centricity Research Etobicoke
state: Ontario
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Nepean
country: Canada
facility: LMC Research Inc. Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Diabetes Heart Research Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Medical Acadie
state: Quebec
city: Pointe-Claire
country: Canada
facility: Centricity Res Pointe-Claire
state: Quebec
city: Saint-Laurent
country: Canada
facility: LMC Clin Rsrch Inc. (Montreal)
state: Quebec
city: Bad Mergentheim
country: Germany
facility: Diabetespraxis Mergentheim
city: Elsterwerda
country: Germany
facility: Zentrum fuer klinische Studien Suedbrandenburg GmbH
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Hamburg
country: Germany
facility: Wendisch/Dahl Hamburg
city: Leipzig
country: Germany
facility: AmBeNet GmbH
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Zentrum für klinische Studien Alexander Segner
city: Stuttgart
country: Germany
facility: Erlinger
city: Wangen
country: Germany
facility: Zentrum für klinische Studien Allgäu Oberschwaben
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
state: Csongrád-Csanád
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Belgyógyászati Klinika
state: Hajdu-Bihar
city: Szolnok
country: Hungary
facility: Hetényi Géza Kórház
state: Jász-Nagykun-Szolnok
city: Komárom
country: Hungary
facility: Selye János Kórház és Rendelőintézet
state: Komárom-Esztergom
city: Budapest
country: Hungary
facility: Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: Szőcs Depot Egészségügyi Szolgáltató Kft.
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház
city: Komárom
country: Hungary
facility: Selye János Kórház és Rendelőintézet
city: Szolnok
country: Hungary
facility: Hetényi Géza Kórház
city: Ahmedabad
country: India
facility: HCG Hospitals
state: Gujarat
city: Bangalore
country: India
facility: Ramaiah Memorial Hospital
state: Karnataka
city: Kozhikode
country: India
facility: Calicut Medical College
state: Kerala
city: Thiruvananthapuram
country: India
facility: Indian Institute of Diabetes
state: Kerala
city: Kolhapur
country: India
facility: Excel Endocrine Centre
state: Maharashtra
city: Mumbai
country: India
facility: BYL Nair Hospital and T N Medical College Department of endo
state: Maharashtra
city: Mumbai
country: India
facility: Seth GS medical college and KEM Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Sunil's Diabetes Care n' Research Centre Pvt Ltd
state: Maharashtra
city: Pune
country: India
facility: Noble Hospitals Pvt Ltd.
state: Maharashtra
city: Ansari Nagar
country: India
facility: All India Institute of Medical Sciences_Delhi
state: New Delhi
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research_Chandigarh
state: Punjab
city: Jaipur
country: India
facility: J K Lon Hospital, SMS Medical College & Attached Hospitals
state: Rajasthan
city: Jaipur
country: India
facility: SMS Medical College & Hospital
state: Rajasthan
city: Chennai
country: India
facility: Apollo Research & Innovation (ARI)
state: Tamil Nadu
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
state: Tamil Nadu
city: Hyderabad
country: India
facility: Gleneagles Hospitals
state: Telangana
city: Kolkata
country: India
facility: Apollo Multispeciality Hospital, Kolkata
state: West Bengal
city: Kolkata
country: India
facility: Apollo Multispeciality Hospitals Limited
state: West Bengal
city: Nagpur
country: India
facility: Sunil's Diabetes Care n' Research Centre Pvt Ltd
city: New Delhi
country: India
facility: Lady Hardinge Medical College
city: Galway
country: Ireland
facility: CRF - Galway
state: Connaght
city: Dublin
country: Ireland
facility: Clinical Research Centre, St. Vincent's University Hospital,
state: Leinster
city: Dublin
country: Ireland
facility: Mater Miscericordiae Hospital
state: Leinster
city: Dublin
country: Ireland
facility: St James's CRF
state: Leinster
city: Dublin
country: Ireland
facility: Connolly Hospital
state: Leinster
city: Dublin
country: Ireland
facility: Mater Miscericordiae Hospital
state: Leinster
city: Aichi
country: Japan
facility: TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
city: Chiba
country: Japan
facility: Tokuyama clinic
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Osaka
country: Japan
facility: Osaka Nishiumeda Clinic_Diabetes Internal Medicine
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Takatsuki Red Cross Hospital
city: Cheras
country: Malaysia
facility: Hospital Universiti Kebangsaan Malaysia
state: Kuala Lumpur
city: Sarawak
country: Malaysia
facility: Hospital Miri
state: Miri
city: Seri Manjung
country: Malaysia
facility: Hospital Seri Manjung
state: Perak
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Ampang, Selangor
country: Malaysia
facility: Hospital Ampang
state: Selangor
city: Sungai Buloh
country: Malaysia
facility: University Technology MARA (UiTM) - Sg Buloh
state: Selangor
city: Melaka
country: Malaysia
facility: Hospital Melaka
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Wilayah Persekutuan Putrajaya
country: Malaysia
facility: Hospital Putrajaya
city: Legnica
country: Poland
facility: Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
state: Dolnośląskie
city: Bygdoszcz
country: Poland
facility: Gierach-Med
state: Kuyavian-Pomeranian Voivodeship
city: Lublin
country: Poland
facility: Terpa Sp. z o.o. Sp. k.
state: Lubelskie Voivodeship
city: Warszawa
country: Poland
facility: Instytut Diabetologii Sp. z o.o.
state: Mazovian Voivodeship
city: Warszawa
country: Poland
facility: Instytut Diabetologii Sp. z o.o.
state: Mazovian
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego
state: Mazowieckie
city: Warszawa
country: Poland
facility: Medical Concierge Centrum Medyczne
state: Mazowieckie
city: Kraków
country: Poland
facility: Linden sp. z o.o. sp. k.
state: Małopolskie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie Voivodeship
city: Bialystok
country: Poland
facility: Gabinet Leczenia Otylosci i Chorob Dietozaleznych
state: Podlaskie Voivodeship
city: Bialystok
country: Poland
facility: Gabinet Leczenia Otylosci i Chorob Dietozaleznych
state: Podlaskie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Salvia
state: Slaskie Voivodeship
city: Elblag
country: Poland
facility: Klinika Bellamed
state: Warmińsko-Mazurskie
city: Poznan
country: Poland
facility: Centrum Zdrowia Metabolicznego
state: Wielkopolskie Voivodeship
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Bygdoszcz
country: Poland
facility: Gierach-Med
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Kraków
country: Poland
facility: Linden sp. z o.o. sp. k.
city: Lublin
country: Poland
facility: Terpa Sp. z o.o. Sp. k.
city: Piotrków Trybunalski
country: Poland
facility: Trialmed CRS
state: Łódzkie
city: Ponce
country: Puerto Rico
facility: Ponce Med School Found Inc
city: Bangkoknoi, Bangkok
country: Thailand
facility: Siriraj Hospital_Bangkoknoi, Bangkok
state: Bangkok
city: Muang
country: Thailand
facility: Srinagarind Hospital
state: Khon Kaen
city: Klong Luang, Pathumthani
country: Thailand
facility: Thammasat University Hospital
state: Pathumthani
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
state: Ratchathewi Bangkok
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital_Bangkok
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: North Yorkshire
city: Addlestone
country: United Kingdom
facility: Crouch Oak Family Practice
state: Surrey
city: Antrim
country: United Kingdom
facility: Antrim Area Hospital
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
city: Bradford-on-Avon
country: United Kingdom
facility: The Health Centre
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Chippenham
country: United Kingdom
facility: Hathaway Medical Centre
city: Hounslow
country: United Kingdom
facility: HMC Health Heston
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: Nantwich
country: United Kingdom
facility: Kiltearn Medical Centre
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre
city: Sandbach
country: United Kingdom
facility: Ashfields Primary Care Centre
city: Soham
country: United Kingdom
facility: The Staploe Medical Centre
city: Swansea
country: United Kingdom
facility: Joint Clinical Research Facility - Swansea
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital (Treliske)
city: Wellingborough
country: United Kingdom
facility: Albany House Medical Centre
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: