A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Obesity Clinical Trial

— REDEFINE 2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05394519
• Other study ID #: NN9838-4609
• Secondary ID: U1111-1267-42872
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 1, 2023
• Est. completion date: January 29, 2025

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: January 29, 2025
• Est. primary completion date: December 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a-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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Cagrilintide
Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
• Semaglutide
Semaglutide administered subcutaneously (s.c., under the skin) once-weekly
• Placebo cagrilintide
Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
• Placebo semaglutide
Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Locations

Country	Name	City	State
Austria	Universitätsklinik für Innere Medizin	Graz
Austria	Fließer-Görzer [Ordination]	Saint Stefan
Austria	Imed 19- privat	Wien
Austria	Klinik Landstraße	Wien
Austria	Universitätsklinikum AKH Wien	Wien
Canada	Dr. Harpreet Bajaj	Brampton	Ontario
Canada	C-endo Diab Endo Clin Calgery	Calgary	Alberta
Canada	LMC Clin Res Inc. Calgary	Calgary	Alberta
Canada	Centricity Research Etobicoke	Etobicoke	Ontario
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	Milestone Research	London	Ontario
Canada	Centre Medical Acadie	Montreal	Quebec
Canada	Commonwealth Medical Clinic	Mount Pearl	Newfoundland and Labrador
Canada	LMC Research Inc. Ottawa	Nepean	Ontario
Canada	Centricity Res Pointe-Claire	Pointe-Claire	Quebec
Canada	LMC Clin Rsrch Inc. (Montreal)	Saint-Laurent	Quebec
Canada	Diabetes Heart Research Centre	Toronto	Ontario
Canada	Dr. M.B. Jones Inc	Victoria	British Columbia
Germany	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
Hungary	Bajcsy-Zsilinszky Kórház	Budapest
Hungary	Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.	Budapest
Hungary	Szocs Depot Egészségügyi Szolgáltató Kft.	Budapest
Hungary	Debreceni Egyetem Belgyógyászati Klinika	Debrecen	Hajdu-Bihar
Hungary	Selye János Kórház és Rendelointézet	Komárom
Hungary	Selye János Kórház és Rendelointézet	Komárom	Komárom-Esztergom
Hungary	Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ	Szeged	Csongrád-Csanád
Hungary	Hetényi Géza Kórház	Szolnok
Hungary	Hetényi Géza Kórház	Szolnok	Jász-Nagykun-Szolnok
India	HCG Hospitals	Ahmedabad	Gujarat
India	All India Institute of Medical Sciences_Delhi	Ansari Nagar	New Delhi
India	Ramaiah Memorial Hospital	Bangalore	Karnataka
India	Post Graduate Institute of Medical Education & Research_Chandigarh	Chandigarh	Punjab
India	Apollo Research & Innovation (ARI)	Chennai	Tamil Nadu
India	Madras Diabetes Research Foundation	Chennai	Tamil Nadu
India	Gleneagles Hospitals	Hyderabad	Telangana
India	J K Lon Hospital, SMS Medical College & Attached Hospitals	Jaipur	Rajasthan
India	SMS Medical College & Hospital	Jaipur	Rajasthan
India	Excel Endocrine Centre	Kolhapur	Maharashtra
India	Apollo Multispeciality Hospital, Kolkata	Kolkata	West Bengal
India	Apollo Multispeciality Hospitals Limited	Kolkata	West Bengal
India	Calicut Medical College	Kozhikode	Kerala
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	Maharashtra
India	Sunil's Diabetes Care n' Research Centre Pvt Ltd	Nagpur
India	Lady Hardinge Medical College	New Delhi
India	Noble Hospitals Pvt Ltd.	Pune	Maharashtra
India	Indian Institute of Diabetes	Thiruvananthapuram	Kerala
Ireland	Clinical Research Centre, St. Vincent's University Hospital,	Dublin	Leinster
Ireland	Connolly Hospital	Dublin	Leinster
Ireland	Mater Miscericordiae Hospital	Dublin	Leinster
Ireland	Mater Miscericordiae Hospital	Dublin	Leinster
Ireland	St James's CRF	Dublin	Leinster
Ireland	CRF - Galway	Galway	Connaght
Japan	TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology	Aichi
Japan	Tokuyama clinic	Chiba
Japan	Naka Kinen Clinic	Ibaraki
Japan	AMC NISHI-UMEDA Clinic_Diabetes Internal Medicine	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Takatsuki Red Cross Hospital	Osaka
Malaysia	Hospital Ampang	Ampang, Selangor	Selangor
Malaysia	Hospital Universiti Kebangsaan Malaysia	Cheras	Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching	Sarawak
Malaysia	Hospital Melaka	Melaka
Malaysia	Hospital Miri	Sarawak	Miri
Malaysia	Hospital Tuanku Jaafar	Seremban
Malaysia	Hospital Seri Manjung	Seri Manjung	Perak
Malaysia	University Technology MARA (UiTM) - Puncak Alam	Sungai Buloh	Selangor
Malaysia	Hospital Putrajaya	Wilayah Persekutuan Putrajaya
Poland	Gabinet Leczenia Otylosci i Chorob Dietozaleznych	Bialystok	Podlaskie Voivodeship
Poland	Gabinet Leczenia Otylosci i Chorob Dietozaleznych	Bialystok	Podlaskie
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie Voivodeship
Poland	Gierach-Med	Bygdoszcz
Poland	Gierach-Med	Bygdoszcz	Kuyavian-Pomeranian Voivodeship
Poland	Klinika Bellamed	Elblag	Warminsko-Mazurskie
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk	Pomorskie
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Centrum Medyczne Salvia	Katowice	Slaskie Voivodeship
Poland	Linden sp. z o.o. sp. k.	Kraków	Malopolskie
Poland	Linden sp. z o.o. sp. k.	Kraków
Poland	Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.	Legnica	Dolnoslaskie
Poland	Terpa Sp. z o.o. Sp. k.	Lublin	Lubelskie Voivodeship
Poland	Terpa Sp. z o.o. Sp. k.	Lublin
Poland	Trialmed CRS	Piotrków Trybunalski	Lódzkie
Poland	Centrum Zdrowia Metabolicznego	Poznan	Wielkopolskie Voivodeship
Poland	Instytut Diabetologii Sp. z o.o.	Warszawa	Mazovian Voivodeship
Poland	Instytut Diabetologii Sp. z o.o.	Warszawa	Mazovian
Poland	Medical Concierge Centrum Medyczne	Warszawa	Mazowieckie
Poland	Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego Centrum Medycznego Ksztalcenia Podyplomowego	Warszawa	Mazowieckie
Puerto Rico	Ponce Med School Found Inc	Ponce
Thailand	King Chulalongkorn Memorial Hospital_Bangkok	Bangkok
Thailand	Rajavithi Hospital	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital_Bangkoknoi, Bangkok	Bangkoknoi, Bangkok	Bangkok
Thailand	Thammasat University Hospital	Klong Luang, Pathumthani	Pathumthani
Thailand	Srinagarind Hospital	Muang	Khon Kaen
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	Harrogate District Hospital	Harrogate, North Yorkshire
United Kingdom	HMC Health Heston	Hounslow,
United Kingdom	Leicester General Hospital	Leicester
United Kingdom	Kiltearn Medical Centre	Nantwich
United Kingdom	Clifton Medical Centre	Rotherham
United Kingdom	Ashfields Primary Care Centre	Sandbach
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 States	Albany Medical College - Endo	Albany	New York
United States	Amarillo Med Spec LLP	Amarillo	Texas
United States	Texas Diab & Endo, P.A.	Austin	Texas
United States	Texas Diab & Endo, P.A.	Austin	Texas
United States	Pennington Biom Res Ctr	Baton Rouge	Louisiana
United States	Northern Pines Hlth Ctr, PC	Buckley	Michigan
United States	Mercury Str Med Grp, PLLC	Butte	Montana
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Clinical Res Of W Florida Inc	Clearwater	Florida
United States	John Muir Physicians Network	Concord	California
United States	North Texas Endocrine Center	Dallas	Texas
United States	UT Southwestern Med Cntr	Dallas	Texas
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Headlands Research California, LLC	Escondido	California
United States	Northeast Research Institute	Fleming Island	Florida
United States	St. Jos Heritage Hlthcr_Fllrtn	Fullerton	California
United States	New West Physicians,Inc.	Golden	Colorado
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	East West Med Res Inst	Honolulu	Hawaii
United States	PlanIt Research, PLLC	Houston	Texas
United States	Diabetes/Lipid Mgmt & Res Ctr	Huntington Beach	California
United States	Jacksonville Ctr For Clin Res	Jacksonville	Florida
United States	Holston Medical Group	Kingsport	Tennessee
United States	Clinical Trials Research	Lincoln	California
United States	DCOL Ctr for Clin Res	Longview	Texas
United States	Velocity Clin Res Wstlke	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	International Diabetes Center	Minneapolis	Minnesota
United States	Renstar Medical Research	Ocala	Florida
United States	Capital Clin Res Ctr,LLC	Olympia	Washington
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	Desert Oasis Hlthcr Med Group	Palm Springs	California
United States	National Clin Res Inc.	Richmond	Virginia
United States	Endo Res Solutions Inc	Roswell	Georgia
United States	Chrysalis Clinical Research	Saint George	Utah
United States	StudyMetrix Research LLC	Saint Peters	Missouri
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Hillcrest Clinical Research	Simpsonville	South Carolina
United States	Cotton-Oneill Diabetes and End	Topeka	Kansas
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Iowa Diab & Endo Res Center	West Des Moines	Iowa
United States	Southgate Medical Group, LLP	West Seneca	New York
United States	Great Lakes Medical Research	Westfield	New York
United States	Amherst Family Practice P.C.	Winchester	Virginia
United States	Selma Medical Associates	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Germany,  Hungary,  India,  Ireland,  Japan,  Malaysia,  Poland,  Puerto Rico,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 68)
Primary	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 = 20% weight reduction	Count of participant.	From baseline (week 0) to end of treatment (week 68)
Secondary	Relative change in body weight	Measured in %.	From baseline (week 0) to week 20
Secondary	Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Glycated Haemoglobin (HbA1c)	Measured in %-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Systolic Blood Pressure (SBP)	Measured in millimeter of mercury (mmHg).	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score	Measured in score points.	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score	Measured in score points.	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in body weight	Measured in kilogram (kg).	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in body mass index (BMI)	Measured in kilogram per meter square (kg/m^2).	From baseline (week 0) to end of treatment (week 68)
Secondary	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)	Count of participant.	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of HbA1c less than or equal to (=) 6.5%	Count of participant.	At end of treatment (week 68)
Secondary	Change in Fasting Plasma Glucose (mmol/L)	Measured in millimoles per liter (mmol/L).	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Fasting Plasma Glucose (mg/dL)	Measured in milligram per deciliter (mg/dL)	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in fasting serum insulin	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Diastolic Blood Pressure (DBP)	Measured in mmHg.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in C-reactive protein (CRP)	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	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	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score	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.	From baseline (week 0) to end of treatment (week 68)
Secondary	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	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.	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score	Count of participant.	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score	Count of participant.	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in IWQOL-Lite-CT Physical Function score		From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup	Count of participant.	From baseline (week 0) to end of treatment (week 68)
Secondary	Continuous glucose monitoring: Change in mean glucose (mmol/L)	Measured in mmol/L.	From baseline (week 0) to end of treatment (week 68)
Secondary	Continuous glucose monitoring: Change in mean glucose (mg/L)	Measured in mg/L.	From baseline (week 0) to end of treatment (week 68)
Secondary	CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)	Measured in %-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)	Measured in %-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL)	Measured in %-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL)	Measured in %-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	CGM: Within-day glycaemic variability (% CV)	Measured in %.	At 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 75)
Secondary	Number of Treatment Emergent Serious adverse events (TESAEs)	Count of events.	From baseline (week 0) to end of study (week 75)
Secondary	Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)	Count of episodes.	From baseline (week 0) to end of study (week 75)
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 75)