Full Year 2023 Investor Presentation
73
Investor presentation
Full year 2023
The CagriSema phase 3 programme, REDEFINE, was initiated in
the Q4 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Ⓡ
Week
0
+
16
68
75
Week
0
+
16
68
75
Dose
escalation
Treatment
maintenance
Follow-
up
Dose
escalation
Treatment
maintenance
Follow-
up
Inclusion criteria
REDEFINE 1:
• BMI: ≥ 30 kg/m² or ≥ 27 kg/m² and ≥1 comorbidity
Excludes diabetes diagnosis or HbA1c ≥ 6.5%
.
REDEFINE 2:
Primary endpoints:
Change in body weight (%)
Achieve ≥ 5% body weight reduction
.
BMI: ≥ 27 kg/m²
Type 2 diabetes, HbA1c <10%
Confirmatory secondary endpoints:
.
Change in waist circumference
HbA1c
Systolic blood pressure
Patient reported outcomes²
'As 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