Investor Presentaiton
R&D investor presentation
18
Semaglutide showed significant improvements in NASH resolution in
phase 2 and could play a key role in preventing disease progression
Semaglutide showed resolution of NASH with no
worsening of fibrosis versus placebo in the phase 2 trial¹
Proportion
of patients
Key take-aways
100%
80%
60%
40%
22.9%
20%
66.7%*
47.3%*
46.9% *
0%
Placebo
0.1 mg
0.2 mg
0.4 mg
Semaglutide once-daily
NASH resolution without worsening of fibrosis
is one of two critical endpoints defined by the
FDA and EMA²
For prevention of NASH disease progression,
NASH resolution could be the more relevant
endpoint
To date, semaglutide NASH results are
arguably the most convincing NASH
resolution data shown
*statistically significant at 72 weeks (p<0.05 vs placebo). Based on a complete case analysis using people with an evaluable biopsy at end of trial
1 Analysis included patients with fibrosis stage 1, 2 or 3 at baseline
2 FDA guidance on developing treatment for NASH: "Noncirrhotic Non-alcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment Guidance for Industry".
EMA guidance on developing treatment for NASH: "Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)"
NASH: non-alcoholic steatohepatitis.0
novo nordiskView entire presentation