NCT02970942

Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis

Conditions

• Hepatobiliary Disorders
• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Semaglutide	Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
DRUG	Placebo	Once daily administration subcutaneously ( s.c., under the skin)

Timeline

• Start date: 2016-11-30
• Primary completion: 2020-02-13
• Completion: 2020-03-19
• First posted: 2016-11-22
• Last updated: 2021-11-16
• Results posted: 2021-04-21

Locations

158 sites across 17 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Finland, France, Greece, Japan, Netherlands, Puerto Rico, Russia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study