parallel randomized trial

REDEFINE 1

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

Overweight or obesity without diabetes (adults)NCT05567796S001154

Design

Randomized: 3,417
Start year: 2022
Treatment: 68 weeks, follow-up 75 weeks
Countries: multinational
Sponsor: Novo Nordisk A/S (industry)
Eligibility: adults, BMI 30 or more or 27 or more with a complication, no diabetes, HbA1c below 6.5 percent

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized
A1	Cagrilintide and semaglutide 2.4/2.4 mg subcutaneous once weekly CagriSema 2.4 mg/2.4 mg	lifestyle: standard	2,108
A2	Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg	lifestyle: standard	302
A3	Cagrilintide Cagrilintide 2.4 mg	lifestyle: standard	302
A4	Placebo Placebo	lifestyle: standard	705

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Cagrilintide and semaglutide 2.4/2.4 mg subcutaneous once weekly A1	Semaglutide 2.4 mg subcutaneous once weekly A2	Cagrilintide A3	Placebo A4	Whole trial ALL
age	mean (years)					47.0
age	sd (years)					11.8
asian hypertension:no	n	240	25	32	94
asian hypertension:no	percent	17.9	13.5	15.1	21.5
asian hypertension:yes	n	146	19	20	55
asian hypertension:yes	percent	19.1	16.2	22.2	20.5
black hypertension:no	n	67	7	9	20
black hypertension:no	percent	5.0	3.8	4.2	4.6
black hypertension:yes	n	49	9	6	22
black hypertension:yes	percent	6.4	7.7	6.7	8.2
bmi	mean (kg/m2)					37.9
bmi	sd (kg/m2)					6.7
egfr hypertension:no	mean (mL/min/1.73 m2)	98.6	97.8	97.5	98.7
egfr hypertension:no	sd (mL/min/1.73 m2)	15.6	15.9	15.7	16.8
egfr hypertension:yes	mean (mL/min/1.73 m2)	91.1	91.5	92.0	92.8
egfr hypertension:yes	sd (mL/min/1.73 m2)	17.3	17.1	17.0	15.9
female	percent					67.6
hba1c	mean (percent)					5.5
hba1c	sd (percent)					0.4
hispanic hypertension:no	n	179	21	17	52
hispanic hypertension:no	percent	13.3	11.4	8.0	11.9
hispanic hypertension:yes	n	64	12	7	19
hispanic hypertension:yes	percent	8.4	10.3	7.8	7.1
other race american indian alaska native hypertension:no	n	2	0	1	1
other race american indian alaska native hypertension:no	percent	0.1		0.5	0.2
other race american indian alaska native hypertension:yes	n	1	0	0	2
other race american indian alaska native hypertension:yes	percent	0.1			0.7
other race multiple hypertension:no	n	12	2	0	2
other race multiple hypertension:no	percent	0.9	1.1		0.5
other race multiple hypertension:yes	n	2	0	0	1
other race multiple hypertension:yes	percent	0.3			0.4
other race native hawaiian pacific islander hypertension:no	n	3	0	0	1
other race native hawaiian pacific islander hypertension:no	percent	0.2			0.2
other race native hawaiian pacific islander hypertension:yes	n	1	0	0	0
other race native hawaiian pacific islander hypertension:yes	percent	0.1
sbp	mean (mmHg)					127.1
sbp	sd (mmHg)					14.2
waist hypertension:no	mean (cm)	113.6	113.7	112.9	113.4
waist hypertension:no	sd (cm)	15.1	15.1	13.8	14.3
waist hypertension:yes	mean (cm)	117.4	115.0	116.9	115.2
waist hypertension:yes	sd (cm)	16.4	15.6	17.1	16.8
weight hypertension:no	mean (kg)	106.0	105.0	105.9	106.8
weight hypertension:no	sd (kg)	22.1	18.7	20.8	21.4
weight hypertension:yes	mean (kg)	109.4	107.2	108.2	106.4
weight hypertension:yes	sd (kg)	24.9	23.6	27.2	27.1
white	percent					72.0

Results

15 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Systolic blood pressure change (8 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Detail
68	A1	change	-10.9 mmHg		hypothetical; other; R0006424:Results
68	A1 vs A4	md	-8.2 mmHg	-9.3 to -7.1	hypothetical; other; R0006424:Results
68	A2	change	-8.5 mmHg		hypothetical; other; R0006424:Results
68	A2 vs A4	md	-5.8 mmHg	-7.4 to -4.1	hypothetical; other; R0006424:Results
68	A3	change	-5.2 mmHg		hypothetical; other; R0006424:Results
68	A3 vs A4	md	-2.4 mmHg	-4.1 to -0.8	hypothetical; other; R0006424:Results
68	A3 vs A4	md	-2.4 mmHg	-4.0 to -0.8	hypothetical; other; R0006424:Figure 1A
68	A4	change	-2.8 mmHg		hypothetical; other; R0006424:Results

Percent body weight change (4 lines; O10)

Week	Arm	Statistic	Estimate	Events / N	Detail
68	A1	percent change	-22.7 percent	1444	hypothetical; other; R0006055:Figure 2
68	A2	percent change	-16.1 percent	220	hypothetical; other; R0006055:Figure 2
68	A3	percent change	-11.8 percent	223	hypothetical; other; R0006055:Figure 2
68	A4	percent change	-2.3 percent	451	hypothetical; other; R0006055:Figure 2

Weight loss of 20 percent or more (3 lines; O11D)

Week	Arm	Statistic	Estimate	Detail
68	A1	responders	61.5	not stated; other; R0006424:Results
68	A2	responders	29.5	not stated; other; R0006424:Results
68	A3	responders	15.2	not stated; other; R0006424:Results