Trial · Interventional

CompletedPhase 1Registry data

A Study on How Semaglutide Works on Early Stages of Scar Tissue in the Liver Assessed by Pictures of the Liver

NCTNCT03357380Other idNN9931-4381Other id2017-001193-42Other idU1111-1194-3900Other id2017

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 67 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
Germany
Start: 28 Nov 2017
Primary completion: 20 Mar 2020
Completion: 20 Mar 2020
First posted: 29 Nov 2017
Last update posted: 22 Nov 2021
Conditions: Hepatobiliary Disorders · Non-alcoholic Fatty Liver Disease

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20172018201920202021

Ph 1
A Study on How Semaglutide Works on Early Stages of Scar Tissue in the Liver Assessed by Pictures of the Liver
NCT03357380
28 Nov 2017 to 20 Mar 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is looking at the effect of semaglutide on subjects with nonalcoholic fatty liver disease.This study is comparing the change in early stages of scar tissue in the liver and fat deposition in the liver in people taking semaglutide and placebo (a dummy medicine). Participants will either get semaglutide or placebo; which treatment participants get is decided by chance. Semaglutide is a medicine under clinical investigation. That means that the medicine has not yet been approved by the authorities. Participants will need to self-inject medicine once daily for 72 weeks. The medicine should be injected under the skin in the stomach, thigh or upper arm. There are about 3 weeks before participants start the study medicine and 7 weeks after you stop it. The study will last for about 82 weeks in total. Participants will have 12 clinic visits, 6 phone calls and 4 visits to an MRI centre. The study includes MRI scans of the stomach. The MRI scans will take place at a different location. Participants will be excluded from the study if the study doctor thinks that there are risks for participants health. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Interventions

SemaglutideDrug
PlaceboDrug

Arms2

Experimental
Semaglutide
Semaglutide will be initiated with a starting dose of 0.05 mg/day for the first 4 weeks. The dose will be increased every 4 weeks until the target dose of 0.4 mg/day has been reached.
Placebo comparator
Placebo
Placebo will be initiated with a starting volume corresponding to 0.05 mg/day of semaglutide for the first 4 weeks. The volume will then be increased every 4 weeks until the target volume corresponding to 0.4 mg/day of semaglutide has been reached.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Time frame · Up to day -20, week 48
Registry description
Measured in KPa

Secondary outcomes(20)

Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Time frame · Up to day -20, week 24
Registry description
Measured in KPa
Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Time frame · Up to day -20, week 72
Registry description
Measured in KPa
Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame · Up to day -20, week 24
Registry description
Measured in Percentage (%)
Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame · Up to day -20, week 48
Registry description
Measured in Percentage (%)
Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame · Up to day -20, week 72
Registry description
Measured in Percentage (%)
Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame · Up to day -20, week 24
Registry description
Measured in Percentage (%)
Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame · Up to day -20, week 48
Registry description
Measured in L
Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame · Up to day -20, week 72
Registry description
Measured in L
Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame · Weeks 0 - 24
Registry description
Number of subjects
Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame · Weeks 0 - 48
Registry description
Number of subjects
Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame · Weeks 0 - 72
Registry description
Number of subjects
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Time frame · Weeks 0 - 24
Registry description
Number of subjects
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Time frame · Weeks 0 - 48
Registry description
Number of subjects
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Time frame · Weeks 0 - 72
Registry description
Number of subjects
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame · Up to day -20, week 24
Registry description
Measured in L
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame · Up to day -20, week 48
Registry description
Measured in L
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame · Up to day -20, week 72
Registry description
Measured in L
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame · Up to day -20, week 24
Registry description
Measured in L
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame · Up to day -20, week 48
Registry description
Measured in L
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame · Up to day -20, week 72
Registry description
Measured in L

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

6 results

Randomised clinical trial: semaglutide versus placebo reduced liver steatosis but not liver stiffness in subjects with non-alcoholic fatty liver disease assessed by magnetic resonance imaging.

Flint et al. 2021Alimentary pharmacology & therapeuticscited by 189

PMID 34570916PMC9292692DOI 10.1111/apt.16608PUB-34570916

Free to read · publisher termsCC BY-NC6 results

Read at source See results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedAndersen G, Plum-Morschel L, Hockings PD, Morsing A, Palle MS, Svolgaard O, Flint A. Clinical Characteristics of a Non-Alcoholic Fatty Liver Disease Population Across the Fibrosis Spectrum Measured by Magnetic Resonance Elastography: Analysis of Screening Data. Adv Ther. 2020 Dec;37(12):4866-4876. doi: 10.1007/s12325-020-01503-x. Epub 2020 Oct 1. PMID 33006125

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent * Liver steatosis greater than or equal to 10% measured by magnetic resonance imaging proton density fat fraction at screening * Liver stiffness between 2.50 and 4.63 kPa (both inclusive) measured by magnetic resonance elastography at screening * Body mass index between 25.0 and 40.0 kg/sqm (both inclusive) at the screening visit Exclusion Criteria: * Known or suspected abuse of alcohol (greater than 12 g/day for women or greater than 24 g/day for men) or alcohol dependence assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire) * Diagnosis of type 1 diabetes according to medical records * Glycosylated haemoglobin A1c (HbA1c) greater than 9.5% at screening * History or presence of pancreatitis (acute or chronic) as declared by the subject * Screening calcitonin greater than or equal to 100 ng/L * Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject) * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods. (Highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence (only acceptable if corresponding to the preferred and usual lifestyle of the subject) or a surgically sterilised partner)

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