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

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  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)
• Placebo — DRUG
  Once daily administration subcutaneously ( s.c., under the skin)

Study Details

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

Key Dates

Start date

Nov 30, 2016

Status verified

Nov 2021

Primary completion

Feb 13, 2020

Completion

Mar 19, 2020

Study Design

Enrollment

320 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide 0,1 mg
• Experimental: Semaglutide 0,2 mg
• Experimental: Semaglutide 0,4 mg
• Placebo Comparator: Placebo 1
• Placebo Comparator: Placebo 2
• Placebo Comparator: Placebo 3

Primary Outcome Measure

Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) [ Time Frame: After 72 weeks ]

Locations (39)

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