Novo Nordisk Investor Presentation - First Nine Months of 2016
Investor presentation
First nine months of 2016
Slide 85
Semaglutide once daily phase 2 dose-finding trial in
obesity is designed to optimise treatment outcomes
Once-daily semaglutide phase 2 trial design
semaglutide 0.05 mg
semaglutide 0.1 mg
semaglutide 0.2 mg
935 people
semaglutide 0.3 mg
with
obesity
without
diabetes¹
semaglutide 0.4 mg
semaglutide 0.3 mg fast escalation
semaglutide 0.4 mg fast escalation
placebo
liraglutide 3 mg
0
4 8
+
16
52 weeks
•
Phase 2 trial purpose and endpoints
Purpose
To assess and compare the dose response of five doses of
once-daily sc semaglutide versus placebo in inducing and
maintaining weight loss after 52 weeks
To investigate two different dose escalation regimens
Trial design
•
•
Randomised, controlled, double-blinded
Diet and exercise counselling in all arms
Primary endpoint
Relative change from baseline in body weight at 52 weeks
Examples of secondary endpoints
Proportion of subjects with weight loss of ≥ 5% or ≥ 10% of
baseline body weight at 52 weeks
Results from phase 2 trial expected in 2017
1 Key inclusion criteria: Male or female ≥18 years, BMI: ≥30 kg/m², Stable body weight (<5 kg change)
≥90 days
Note: Once-daily subcutaneous dosing in all arms, 4-week escalation steps in main arms, 2-week
escalation steps in fast escalation arms
QD: once-daily; sc: subcutaneous
changing
diabetes®
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