A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
- Conditions
- OverweightObesityType 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT05394519
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo semaglutide Placebo cagrilintide + semaglutide once weekly CagriSema Cagrilintide Cagrilintide + semaglutide once weekly Placebo Placebo cagrilintide Placebo cagrilintide + semaglutide once weekly CagriSema Semaglutide Cagrilintide + semaglutide once weekly
- Primary Outcome Measures
Name Time Method Achievement of greater than or equal to (≥) 5% weight reduction From baseline (week 0) to end of treatment (week 68) Count of participant.
Relative change in body weight From baseline (week 0) to end of treatment (week 68) Measured in percentage (%).
- Secondary Outcome Measures
Name Time Method Change in body weight From baseline (week 0) to end of treatment (week 68) Measured in kilogram (kg).
Change in waist circumference From baseline (week 0) to end of treatment (week 68) Measured in centimeter (cm).
Change in Glycated Haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 68) Measured in %-points.
Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score From baseline (week 0) to end of treatment (week 68) Measured in score points.
Ratio to baseline in fasting serum insulin From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Change in Diastolic Blood Pressure (DBP) From baseline (week 0) to end of treatment (week 68) Measured in mmHg.
Change in Systolic Blood Pressure (SBP) From baseline (week 0) to end of treatment (week 68) Measured in millimeter of mercury (mmHg).
Achievement of ≥ 20% weight reduction From baseline (week 0) to end of treatment (week 68) Count of participant.
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) From baseline (week 0) to end of treatment (week 68) Count of participant.
Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score From baseline (week 0) to end of treatment (week 68) Count of participant.
Change in IWQOL-Lite-CT Physical Function score From baseline (week 0) to end of treatment (week 68) CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL) From baseline (week 0) to end of treatment (week 68) Measured in %-points.
Change in body mass index (BMI) From baseline (week 0) to end of treatment (week 68) Measured in kilogram per meter square (kg/m\^2).
Change in Fasting Plasma Glucose (mmol/L) From baseline (week 0) to end of treatment (week 68) Measured in millimoles per liter (mmol/L).
Change in Fasting Plasma Glucose (mg/dL) From baseline (week 0) to end of treatment (week 68) Measured in milligram per deciliter (mg/dL)
Ratio to baseline in C-reactive protein (CRP) From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Relative change in body weight From baseline (week 0) to week 20 Measured in %.
Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score From baseline (week 0) to end of treatment (week 68) Measured in score points.
Achievement of HbA1c less than or equal to (≤) 6.5% At end of treatment (week 68) Count of participant.
Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup From baseline (week 0) to end of treatment (week 68) Count of participant.
CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL) From baseline (week 0) to end of treatment (week 68) Measured in %-points.
CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL) From baseline (week 0) to end of treatment (week 68) Measured in %-points.
CGM: Within-day glycaemic variability (% CV) At end of treatment (week 68) Measured in %.
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) From baseline (week 0) to end of study (week 75) Count of episodes.
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold From baseline (week 0) to end of study (week 75) Count of episodes.
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) From baseline (week 0) to end of treatment (week 68) Measured in %-points.
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 From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score From baseline (week 0) to end of treatment (week 68) IWQOL-Lite-CT is a 20-item clinical outcomes assessment (COA) instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. Score ranges for composite score (physical composite, psychosocial composite and physical function composite) and Total score is 0-100. Higher scores indicate better level of functioning.
Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score From baseline (week 0) to end of treatment (week 68) Count of participant.
Number of Treatment Emergent Adverse Events (TEAEs) From baseline (week 0) to end of study (week 75) Count of events.
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 From baseline (week 0) to end of treatment (week 68) CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). Higher score represents a greater level of Craving Control.
Continuous glucose monitoring: Change in mean glucose (mmol/L) From baseline (week 0) to end of treatment (week 68) Measured in mmol/L.
Continuous glucose monitoring: Change in mean glucose (mg/L) From baseline (week 0) to end of treatment (week 68) Measured in mg/L.
Number of Treatment Emergent Serious adverse events (TESAEs) From baseline (week 0) to end of study (week 75) Count of events.
Trial Locations
- Locations (157)
Albany Medical College - Endo
🇺🇸Albany, New York, United States
Texas Diab & Endo, P.A.
🇺🇸Austin, Texas, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
UT Southwestern Med Cntr
🇺🇸Dallas, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Noble Hospitals Pvt Ltd.
🇮🇳Pune, Maharashtra, India
All India Institute of Medical Sciences_Delhi
🇮🇳Ansari Nagar, New Delhi, India
Ashfields Primary Care Centre
🇬🇧Sandbach, United Kingdom
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Kiltearn Medical Centre
🇬🇧Nantwich, United Kingdom
John Muir Physicians Network
🇺🇸Concord, California, United States
Headlands Research California, LLC
🇺🇸Escondido, California, United States
St. Jos Heritage Hlthcr_Fllrtn
🇺🇸Fullerton, California, United States
Diabetes/Lipid Mgmt & Res Ctr
🇺🇸Huntington Beach, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Velocity Clin Res Los Angeles
🇺🇸Los Angeles, California, United States
Velocity Clin Res Wstlke
🇺🇸Los Angeles, California, United States
Desert Oasis Hlthcr Med Group
🇺🇸Palm Springs, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
New West Physicians,Inc.
🇺🇸Golden, Colorado, United States
Clinical Res Of W Florida Inc
🇺🇸Clearwater, Florida, United States
Northeast Research Institute
🇺🇸Fleming Island, Florida, United States
Jacksonville Ctr For Clin Res
🇺🇸Jacksonville, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
AdventHealth Diab Inst
🇺🇸Orlando, Florida, United States
Florida Institute for Clinical Research, LLC
🇺🇸Orlando, Florida, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
Endo Res Solutions Inc
🇺🇸Roswell, Georgia, United States
East West Med Res Inst
🇺🇸Honolulu, Hawaii, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Iowa Diab & Endo Res Center
🇺🇸West Des Moines, Iowa, United States
Cotton-Oneill Diabetes and End
🇺🇸Topeka, Kansas, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Pennington Biom Res Ctr
🇺🇸Baton Rouge, Louisiana, United States
Northern Pines Hlth Ctr, PC
🇺🇸Buckley, Michigan, United States
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
StudyMetrix Research LLC
🇺🇸Saint Peters, Missouri, United States
Mercury Str Med Grp, PLLC
🇺🇸Butte, Montana, United States
Southgate Medical Group, LLP
🇺🇸West Seneca, New York, United States
Great Lakes Medical Research
🇺🇸Westfield, New York, United States
PharmQuest Life Sciences LLC
🇺🇸Greensboro, North Carolina, United States
Hillcrest Clinical Research
🇺🇸Simpsonville, South Carolina, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Amarillo Med Spec LLP
🇺🇸Amarillo, Texas, United States
DCOL Ctr for Clin Res
🇺🇸Longview, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
National Clin Res Inc.
🇺🇸Richmond, Virginia, United States
Selma Medical Associates
🇺🇸Winchester, Virginia, United States
Amherst Family Practice P.C.
🇺🇸Winchester, Virginia, United States
Capital Clin Res Ctr,LLC
🇺🇸Olympia, Washington, United States
Universitätsklinik für Innere Medizin Graz
🇦🇹Graz, Austria
Clifton Medical Centre
🇬🇧Rotherham, United Kingdom
Fließer-Görzer [Ordination]
🇦🇹Saint Stefan, Austria
Klinik Landstraße
🇦🇹Wien, Austria
Universitätsklinikum AKH Wien
🇦🇹Wien, Austria
Imed 19- privat
🇦🇹Wien, Austria
LMC Clin Res Inc. Calgary
🇨🇦Calgary, Alberta, Canada
C-endo Diab Endo Clin Calgery
🇨🇦Calgary, Alberta, Canada
Dr. M.B. Jones Inc
🇨🇦Victoria, British Columbia, Canada
Commonwealth Medical Clinic
🇨🇦Mount Pearl, Newfoundland and Labrador, Canada
Dr. Harpreet Bajaj
🇨🇦Brampton, Ontario, Canada
Centricity Research Etobicoke
🇨🇦Etobicoke, Ontario, Canada
Wharton Med Clin Trials
🇨🇦Hamilton, Ontario, Canada
LMC Research Inc. Ottawa
🇨🇦Nepean, Ontario, Canada
Diabetes Heart Research Centre
🇨🇦Toronto, Ontario, Canada
Centre Medical Acadie
🇨🇦Montreal, Quebec, Canada
Centricity Res Pointe-Claire
🇨🇦Pointe-Claire, Quebec, Canada
LMC Clin Rsrch Inc. (Montreal)
🇨🇦Saint-Laurent, Quebec, Canada
Diabetespraxis Mergentheim
🇩🇪Bad Mergentheim, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
🇩🇪Elsterwerda, Germany
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Wendisch/Dahl Hamburg
🇩🇪Hamburg, Germany
AmBeNet GmbH
🇩🇪Leipzig, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
🇩🇪Münster, Germany
Zentrum für klinische Studien Alexander Segner
🇩🇪Saint Ingbert-Oberwürzbach, Germany
Erlinger
🇩🇪Stuttgart, Germany
Zentrum für klinische Studien Allgäu Oberschwaben
🇩🇪Wangen, Germany
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád-Csanád, Hungary
Debreceni Egyetem Belgyógyászati Klinika
🇭🇺Debrecen, Hajdu-Bihar, Hungary
Hetényi Géza Kórház
🇭🇺Szolnok, Hungary
Selye János Kórház és Rendelőintézet
🇭🇺Komárom, Hungary
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
🇭🇺Budapest, Hungary
Szőcs Depot Egészségügyi Szolgáltató Kft.
🇭🇺Budapest, Hungary
Bajcsy-Zsilinszky Kórház
🇭🇺Budapest, Hungary
HCG Hospitals
🇮🇳Ahmedabad, Gujarat, India
Ramaiah Memorial Hospital
🇮🇳Bangalore, Karnataka, India
Calicut Medical College
🇮🇳Kozhikode, Kerala, India
Indian Institute of Diabetes
🇮🇳Thiruvananthapuram, Kerala, India
Excel Endocrine Centre
🇮🇳Kolhapur, Maharashtra, India
BYL Nair Hospital and T N Medical College Department of endo
🇮🇳Mumbai, Maharashtra, India
Seth GS medical college and KEM Hospital
🇮🇳Mumbai, Maharashtra, India
Sunil's Diabetes Care n' Research Centre Pvt Ltd
🇮🇳Nagpur, India
Post Graduate Institute of Medical Education & Research_Chandigarh
🇮🇳Chandigarh, Punjab, India
J K Lon Hospital, SMS Medical College & Attached Hospitals
🇮🇳Jaipur, Rajasthan, India
SMS Medical College & Hospital
🇮🇳Jaipur, Rajasthan, India
Apollo Research & Innovation (ARI)
🇮🇳Chennai, Tamil Nadu, India
Madras Diabetes Research Foundation
🇮🇳Chennai, Tamil Nadu, India
Gleneagles Hospitals
🇮🇳Hyderabad, Telangana, India
Apollo Multispeciality Hospital, Kolkata
🇮🇳Kolkata, West Bengal, India
Apollo Multispeciality Hospitals Limited
🇮🇳Kolkata, West Bengal, India
Lady Hardinge Medical College
🇮🇳New Delhi, India
CRF - Galway
🇮🇪Galway, Connaght, Ireland
Clinical Research Centre, St. Vincent's University Hospital,
🇮🇪Dublin, Leinster, Ireland
Mater Miscericordiae Hospital
🇮🇪Dublin, Leinster, Ireland
St James's CRF
🇮🇪Dublin, Leinster, Ireland
Connolly Hospital
🇮🇪Dublin, Leinster, Ireland
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
🇯🇵Aichi, Japan
Tokuyama clinic
🇯🇵Chiba, Japan
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
Osaka Nishiumeda Clinic_Diabetes Internal Medicine
🇯🇵Osaka, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Takatsuki Red Cross Hospital
🇯🇵Osaka, Japan
Hospital Universiti Kebangsaan Malaysia
🇲🇾Cheras, Kuala Lumpur, Malaysia
Hospital Miri
🇲🇾Sarawak, Miri, Malaysia
Hospital Seri Manjung
🇲🇾Seri Manjung, Perak, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Sarawak, Malaysia
Hospital Ampang
🇲🇾Ampang, Selangor, Selangor, Malaysia
University Technology MARA (UiTM) - Sg Buloh
🇲🇾Sungai Buloh, Selangor, Malaysia
Hospital Melaka
🇲🇾Melaka, Malaysia
Hospital Tuanku Jaafar
🇲🇾Seremban, Malaysia
Hospital Putrajaya
🇲🇾Wilayah Persekutuan Putrajaya, Malaysia
Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
🇵🇱Legnica, Dolnośląskie, Poland
Gierach-Med
🇵🇱Bygdoszcz, Poland
Terpa Sp. z o.o. Sp. k.
🇵🇱Lublin, Poland
Instytut Diabetologii Sp. z o.o.
🇵🇱Warszawa, Mazovian, Poland
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego
🇵🇱Warszawa, Mazowieckie, Poland
Medical Concierge Centrum Medyczne
🇵🇱Warszawa, Mazowieckie, Poland
Linden sp. z o.o. sp. k.
🇵🇱Kraków, Poland
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
🇵🇱Bialystok, Podlaskie, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Centrum Medyczne Salvia
🇵🇱Katowice, Slaskie Voivodeship, Poland
Klinika Bellamed
🇵🇱Elblag, Warmińsko-Mazurskie, Poland
Centrum Zdrowia Metabolicznego
🇵🇱Poznan, Wielkopolskie Voivodeship, Poland
Trialmed CRS
🇵🇱Piotrków Trybunalski, Łódzkie, Poland
Ponce Med School Found Inc
🇵🇷Ponce, Puerto Rico
Siriraj Hospital_Bangkoknoi, Bangkok
🇹🇭Bangkoknoi, Bangkok, Bangkok, Thailand
Srinagarind Hospital
🇹🇭Muang, Khon Kaen, Thailand
Thammasat University Hospital
🇹🇭Klong Luang, Pathumthani, Pathumthani, Thailand
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
King Chulalongkorn Memorial Hospital_Bangkok
🇹🇭Bangkok, Thailand
Rajavithi Hospital
🇹🇭Bangkok, Thailand
Harrogate District Hospital
🇬🇧Harrogate, North Yorkshire, United Kingdom
Crouch Oak Family Practice
🇬🇧Addlestone, Surrey, United Kingdom
Antrim Area Hospital
🇬🇧Antrim, United Kingdom
Layton Medical Centre
🇬🇧Blackpool, United Kingdom
The Health Centre
🇬🇧Bradford-on-Avon, United Kingdom
Southmead Hospital
🇬🇧Bristol, United Kingdom
Hathaway Medical Centre
🇬🇧Chippenham, United Kingdom
HMC Health Heston
🇬🇧Hounslow, United Kingdom
Leicester General Hospital
🇬🇧Leicester, United Kingdom
The Staploe Medical Centre
🇬🇧Soham, United Kingdom
Joint Clinical Research Facility - Swansea
🇬🇧Swansea, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom
Royal Cornwall Hospital (Treliske)
🇬🇧Truro, United Kingdom
Albany House Medical Centre
🇬🇧Wellingborough, United Kingdom