NCT02970942|CompletedPhase 2ResultsFDA Drug

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9931-42962016-000685-39U1111-1179-7464

Study Type

interventional

Target

320

Locations

16 countries

Sites

153

Timeline

RegisteredNov 2016

StartedNov 2016

CompletionMar 2020

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

320

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2016

Typical duration for phase_2

Geographic Reach

16 countries

153 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

First Submitted

Initial submission to the registry

November 18, 2016

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed

8 days until next milestone

Study Start

First participant enrolled

November 30, 2016

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2020

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

April 21, 2021

Completed

Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

3.2 years

First QC Date

November 18, 2016

Results QC Date

February 11, 2021

Last Update Submit

November 15, 2021

Conditions

Hepatobiliary Disorders Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)
NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
After 72 weeks

Secondary Outcomes (87)

Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)
After 72 weeks
Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)
Baseline (week 0), Week 72
Percentage of Participants With Change in Steatosis
Baseline (week 0), Week 72
Percentage of Participants With Change in Lobular Inflammation
Baseline (week 0), Week 72
Percentage of Participants With Change in Hepatocyte Ballooning
Baseline (week 0), Week 72
+82 more secondary outcomes

Study Arms (6)

Semaglutide 0,1 mg

EXPERIMENTAL

Drug: Semaglutide

Semaglutide 0,2 mg

EXPERIMENTAL

Drug: Semaglutide

Semaglutide 0,4 mg

EXPERIMENTAL

Drug: Semaglutide

Placebo 1

PLACEBO COMPARATOR

Drug: Placebo

Placebo 2

PLACEBO COMPARATOR

Drug: Placebo

Placebo 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SemaglutideDRUG

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)

Semaglutide 0,1 mgSemaglutide 0,2 mgSemaglutide 0,4 mg

PlaceboDRUG

Once daily administration subcutaneously ( s.c., under the skin)

Placebo 1Placebo 2Placebo 3

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.