Investor Presentaiton
Investor presentation
ADA 2019
Novo Nordisk is investigating opportunities within NASH
Semaglutide NASH phase 2 programme
2016
2017
2018
2019
2020
Semaglutide 0.1, 0.2 and 0.4 mg QD
vs placebo in patients with NASH
~320 patients, 72 weeks
Semaglutide 0.4 mg QD
vs placebo in patients with NASH
~70 patients, 72 weeks
Slide 27
Proof of concept phase 2 combination trial design
100 NAFLD/NASH
MRI-PDFF with >
10% steatosis
FibroScan with
liver stiffness ≥ 7
kPa or historical
liver biopsy
Sema 2.4 mg once weekly sc
Sema 2.4 mg + FIR 20 mg once daily oral
Sema 2.4 mg + CIL 30 mg once daily oral
Sema 2.4 mg + CIL 100 mg once daily oral
Sema 2.4 mg + FIR 20 mg + CIL 30 mg
24 weeks + 7 weeks follow-up
Semaglutide 2.4 mg QW
vs placebo in patients with NASH
~70 patients, 48 weeks
Expected phase 2 programme completion: H2 2020
Trial information
• Safety and tolerability trial
Initiation Q3 2019
• MRI-PDFF, MRE & biomarkers at least at: 0, 12, 24 weeks
QD: Once-daily; QW: once-weekly; sc: subcutaneous; MRI-PDFF: magnetic resonance imaging-estimated proton density fat fraction; MRE: magnetic resonance elastography; NASH: nonalcoholic
steatohepatitis; NAFLD: Nonalcoholic fatty liver disease; kPa: kilopascals; FIR: firsocostat (ACC inhibitor); CIL: cilofexor (FXR agonist); ACC: acetyl-CoA carboxylase; FXR: Farnesoid X receptor
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