Investor Presentaiton
74
Investor presentation
Full year 2022
The CagriSema phase 3 programme, REDEFINE, was initiated in
the fourth quarter of 2022
REDEFINE 1 trial design
REDEFINE 2 trial design
CagriSema 2.4 mg/2.4 mg1
N = 3400
N=1200
R
21:3:3:7
Cagrilintide 2.4 mg¹
Semaglutide 2.4 mg1
Placebo¹
CagriSema 2.4 mg/2.4 mg1
R
Placebo¹
3:1
Novo NordiskⓇ
F
+
Week
0
16
+
68
ㅏ
+
Week
0
16
68
75
75
Dose
Treatment
Dose
escalation
Treatment
maintenance
Follow-
up
escalation
maintenance
Follow-
up
Inclusion criteria
REDEFINE 1:
Primary endpoints:
•
BMI: ≥ 30 kg/m² or ≥ 27 kg/m² and ≥1 comorbidity
Excludes diabetes diagnosis or HbA1c ≥ 6.5%
Change in body weight (%)
Achieve ≥ 5% body weight reduction
REDEFINE 2:
.
BMI: ≥ 27 kg/m²
Type 2 diabetes, HbA1c < 10%
Confirmatory secondary endpoints:
Change in waist circumference
HbA1c
•
Systolic blood pressure
• Patient reported outcomes²
1As an adjunct to a reduced-calorie diet and increased physical activity in adults with obesity or overweight. 2 Patient reported outcomes include (IWQOL-Lite-CT, SF-36v2, and Vitality score)
CagriSema: Cagrilintide in combination with semaglutide; T2DM: Type 2 diabetes; BMI: Body mass index; HbA₁: Hemoglobin A₁; IWQOL-Lite-CT: Impact of weight on quality of life - lite, clinical trials version; Short form 36v2View entire presentation