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

NCT02970942 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2021-11-16

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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

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-02-13
Completion
2020-03-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Denmark
  • Finland
  • France
  • Greece
  • Japan
  • Netherlands
  • Puerto Rico
  • Russia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970942 on ClinicalTrials.gov