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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05567796




Registration number
NCT05567796
Ethics application status
Date submitted
3/10/2022
Date registered
5/10/2022
Date last updated
24/05/2024

Titles & IDs
Public title
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Scientific title
Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Secondary ID [2] 0 0
NN9838-4608
Universal Trial Number (UTN)
Trial acronym
REDEFINE 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cagrilintide
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo cagrilintide
Treatment: Drugs - Placebo semaglutide

Experimental: Cagrisema s.c. 2.4 mg/2.4 mg - Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.

Active Comparator: Cagrilintide s.c. 2.4 mg - Participants will receive cagrilintide s.c. 2.4 mg and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.

Active Comparator: Semaglutide s.c. 2.4 mg - Participants will receive semaglutide s.c. 2.4 mg and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.

Placebo Comparator: Placebo s.c. - Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.


Treatment: Drugs: Cagrilintide
Cagrilintide will be administered subcutaneously.

Treatment: Drugs: Semaglutide
Participants will recieve semaglutide subcutaneously.

Treatment: Drugs: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide.

Treatment: Drugs: Placebo semaglutide
Participants will receive placebo matched to semaglutide.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 68)
Primary outcome [2] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [1] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 20% weight reduction
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [2] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 25% weight reduction
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [3] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 30% weight reduction
Timepoint [3] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [4] 0 0
CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg; and CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
Timepoint [4] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [5] 0 0
CagriSema 0.5 mg/0.5 mg versus placebo: Relative change in body weight
Timepoint [5] 0 0
From baseline (week 0) to week 8
Secondary outcome [6] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
Timepoint [6] 0 0
From baseline (week 0) to week 20
Secondary outcome [7] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
Timepoint [7] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [8] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in systolic blood pressure (SBP)
Timepoint [8] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [9] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score
Timepoint [9] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [10] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score
Timepoint [10] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [11] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg: Change in body weight
Timepoint [11] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [12] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo, semalutide 2.4 mg and cagrilintide 2.4 mg: Change in body mass index (BMI)
Timepoint [12] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [13] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg: Improvement in weight category
Timepoint [13] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [14] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Glycated Haemoglobin (HbA1c)
Timepoint [14] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [15] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in HbA1c
Timepoint [15] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [16] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Fasting Plasma Glucose (FPG)
Timepoint [16] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [17] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in FPG
Timepoint [17] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [18] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in fasting serum insulin
Timepoint [18] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [19] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Diastolic Blood Pressure (DBP)
Timepoint [19] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [20] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in total cholesterol
Timepoint [20] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [21] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol
Timepoint [21] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [22] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol
Timepoint [22] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [23] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol
Timepoint [23] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [24] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Triglycerides
Timepoint [24] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [25] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Free fatty acids
Timepoint [25] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [26] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Change in waist circumference
Timepoint [26] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [27] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Change in SBP
Timepoint [27] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [28] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in total cholesterol
Timepoint [28] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [29] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in HDL
Timepoint [29] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [30] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in LDL
Timepoint [30] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [31] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in VLDL
Timepoint [31] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [32] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in Triglycerides
Timepoint [32] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [33] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in Free fatty acids
Timepoint [33] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [34] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight (Measured in kilograms (kg))
Timepoint [34] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [35] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight (Measured in percentage (%))
Timepoint [35] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [36] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Absolute change in body weight (Measured in kilograms (kg))
Timepoint [36] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [37] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Absolute change in body weight (Measured in percentage (%))
Timepoint [37] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [38] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as kilograms (kg))
Timepoint [38] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [39] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as percentage (%))
Timepoint [39] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [40] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as kilograms (kg))
Timepoint [40] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [41] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as percentage (%))
Timepoint [41] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [42] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as percentage (%))
Timepoint [42] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [43] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as %-points)
Timepoint [43] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [44] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as percentage (%))
Timepoint [44] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [45] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as %-points)
Timepoint [45] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [46] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in kilograms (kg))
Timepoint [46] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [47] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in percentage (%))
Timepoint [47] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [48] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in kilograms (kg))
Timepoint [48] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [49] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in percentage (%))
Timepoint [49] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [50] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of at least 14.6- point increase (yes/no) in IWQOL-Lite-CT Physical Function score
Timepoint [50] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [51] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score
Timepoint [51] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [52] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT - Physical Function Score
Timepoint [52] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [53] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT - Psychosocial Score
Timepoint [53] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [54] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT - Total Score
Timepoint [54] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [55] 0 0
Change in Control of Eating (COEQ): Craving Control Score
Timepoint [55] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [56] 0 0
Change in COEQ: Craving for Savoury food score
Timepoint [56] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [57] 0 0
Change in COEQ: Hunger score
Timepoint [57] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [58] 0 0
Change in COEQ: Craving for Sweets Score
Timepoint [58] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [59] 0 0
Change in COEQ: Positive Mood score
Timepoint [59] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [60] 0 0
Change in COEQ: Satiety score
Timepoint [60] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [61] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Change in IWQOL-Lite-CT Physical Function score
Timepoint [61] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [62] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score
Timepoint [62] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [63] 0 0
CagriSema 2.4 mg/2.4 mg versus placebo, semalutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline C-reactive protein (CRP)
Timepoint [63] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [64] 0 0
Number of Treatment Emergent Adverse Events (TEAEs)
Timepoint [64] 0 0
From baseline (week 0) to end of study-main part (week 75)
Secondary outcome [65] 0 0
Number of Treatment Emergent Serious adverse events (TESAEs)
Timepoint [65] 0 0
From baseline (week 0) to end of study-main part (week 75)

Eligibility
Key inclusion criteria
- Male or female

- Age above or equal to 18 years at the time of signing informed consent

- Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter
(kg/m^2) or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least
one weight-related comorbidity including, but not limited to hypertension,
dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent
(48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening b)
History of type 1 or type 2 diabetes mellitus

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/10/2026
Actual
Sample size
Target
3400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [2] 0 0
Holdsworth House Clinical Research - Darlinghurst
Recruitment hospital [3] 0 0
Novatrials - Kotara
Recruitment hospital [4] 0 0
Austrials - Taringa
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2289 - Kotara
Recruitment postcode(s) [4] 0 0
4068 - Taringa
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Rhode Island
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
La Pampa
Country [23] 0 0
Argentina
State/province [23] 0 0
Caba
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad de Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Santiago del Estero
Country [26] 0 0
Belgium
State/province [26] 0 0
Bonheiden
Country [27] 0 0
Belgium
State/province [27] 0 0
Boussu
Country [28] 0 0
Belgium
State/province [28] 0 0
Bruxelles
Country [29] 0 0
Belgium
State/province [29] 0 0
Edegem
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Leuven
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Kyustendil
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Blagoevgrad
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Montana
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Pleven
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Plovdiv
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Ruse
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Smolyan
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Sofia
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Varna
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Yambol
Country [42] 0 0
Canada
State/province [42] 0 0
Alberta
Country [43] 0 0
Canada
State/province [43] 0 0
British Columbia
Country [44] 0 0
Canada
State/province [44] 0 0
New Brunswick
Country [45] 0 0
Canada
State/province [45] 0 0
Nova Scotia
Country [46] 0 0
Canada
State/province [46] 0 0
Ontario
Country [47] 0 0
Denmark
State/province [47] 0 0
Aarhus N
Country [48] 0 0
Denmark
State/province [48] 0 0
Esbjerg
Country [49] 0 0
Denmark
State/province [49] 0 0
Hellerup
Country [50] 0 0
Denmark
State/province [50] 0 0
Hvidovre
Country [51] 0 0
Denmark
State/province [51] 0 0
Køge
Country [52] 0 0
Finland
State/province [52] 0 0
Helsinki
Country [53] 0 0
Finland
State/province [53] 0 0
Kuopio
Country [54] 0 0
Finland
State/province [54] 0 0
Oulu
Country [55] 0 0
Finland
State/province [55] 0 0
Turku
Country [56] 0 0
France
State/province [56] 0 0
Paris
Country [57] 0 0
France
State/province [57] 0 0
Pierre-Benite
Country [58] 0 0
France
State/province [58] 0 0
Saint Herblain
Country [59] 0 0
France
State/province [59] 0 0
Strasbourg cedex 2
Country [60] 0 0
France
State/province [60] 0 0
Venissieux
Country [61] 0 0
Germany
State/province [61] 0 0
Bad Mergentheim
Country [62] 0 0
Germany
State/province [62] 0 0
Elsterwerda
Country [63] 0 0
Germany
State/province [63] 0 0
Essen
Country [64] 0 0
Germany
State/province [64] 0 0
Hamburg
Country [65] 0 0
Germany
State/province [65] 0 0
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Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study has 2 parts: First part is the main study and second part is the extension study.
During the main study participants will receive 1 of 4 study medicines. If participants
continue in the extension study, they will not receive any study medicine during the
extension. The main study will look at how well CagriSema helps participants with excess body
weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and
semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy"
medicine. Which treatment participants get is decided by chance. They will take one injection
once a week. The study medicine is injected briefly with a thin needle, typically in the
stomach, thighs or upper arms.

Extension study: After the main study, not all participants will continue in the extension
study. The study staff will tell the participant if they will continue or not into the
extension study. In the extension study we will look at what happens to the participant's
body weight and diseases related to excess body weight after the participant stops taking the
study medicine. The main study will last for about 1½ years and the extension study will last
for another 2 years.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05567796
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries