Hepatobiliary DisordersPhase 1NCT03357380

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

A Phase 1 study testing Semaglutide in people with Hepatobiliary Disorders and Non-alcoholic Fatty Liver Disease, run by Novo Nordisk A/S at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hepatobiliary Disorders, Non-alcoholic Fatty Liver Disease
What is being tested?: Semaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 2 sitesGermany
Study dates: 28 Nov 2017to 20 Mar 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Novo Nordisk Investigational Site
Mainz, 55116
Novo Nordisk Investigational Site
Neuss, 41460

Other trials in Germany

About this study

Official title: A Trial Investigating the Effect of Subcutaneous Semaglutide on Liver Fibrosis Assessed by Magnetic Resonance Elastography in Subjects With Non-alcoholic Fatty Liver Disease

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.

Conditions: Hepatobiliary Disorders, Non-alcoholic Fatty Liver Disease
Being tested: Semaglutide, Placebo
Medical subject headings: Digestive System Diseases, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SemaglutideDrug
Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.
PlaceboDrug
Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.

Study groups in NCT03357380
Study group	Role	What they receive
Semaglutide	Experimental	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. Receives: Drug: Semaglutide
Placebo	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Measured in KPa
Measured: Up to day -20, week 48

Secondary outcomes (30)

Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Measured in KPa
Measured: Up to day -20, week 24
Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Measured in KPa
Measured: Up to day -20, week 72
Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in Percentage (%)
Measured: Up to day -20, week 24
Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in Percentage (%)
Measured: Up to day -20, week 48
Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in Percentage (%)
Measured: Up to day -20, week 72
Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in Percentage (%)
Measured: Up to day -20, week 24
Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in L
Measured: Up to day -20, week 48
Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured in L
Measured: Up to day -20, week 72
Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Number of subjects
Measured: Weeks 0 - 24
Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Number of subjects
Measured: Weeks 0 - 48
Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Number of subjects
Measured: Weeks 0 - 72
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Number of subjects
Measured: Weeks 0 - 24
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Number of subjects
Measured: Weeks 0 - 48
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Number of subjects
Measured: Weeks 0 - 72
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Measured: Up to day -20, week 24
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Measured: Up to day -20, week 48
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Measured: Up to day -20, week 72
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Measured: Up to day -20, week 24
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Measured: Up to day -20, week 48
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Measured in L
Measured: Up to day -20, week 72
Change in Body weight (% and kg)
Measured in kg and %
Measured: Week 0, week 48
Change in Body weight (% and kg)
Measured in kg and %
Measured: Week 0, week 72
Change in Waist circumference
Measured in cm
Measured: Week 0, week 48
Change in Waist circumference
Measured in cm
Measured: Week 0, week 72
Change in Body mass index (BMI)
Measured in kg/sqm
Measured: Week 0, week 48
Change in Body mass index (BMI)
Measured in kg/sqm
Measured: Week 0, week 72
Number of treatment-emergent adverse events (TEAEs)
Count of adverse events
Measured: Weeks 0 - 48
Number of treatment-emergent adverse events (TEAEs)
Count and % of adverse events
Measured: Weeks 0 - 79
Number of treatment-emergent hypoglycaemic episodes
Count of episodes
Measured: Weeks 0 - 48
Number of treatment-emergent hypoglycaemic episodes
Count of episodes
Measured: Weeks 0 - 79

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 201720 Mar 2020

First posted29 Nov 2017
Study start28 Nov 2017
Primary completion20 Mar 2020
Study completion20 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatobiliary DisordersStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03357380
Sponsor's protocol ID: NN9931-4381
Other IDs: 2017-001193-42, U1111-1194-3900, 2017
Status last verified: Nov 2021
First submitted: 23 Nov 2017
Last updated: 22 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

Flint A, Andersen G, Hockings P, Johansson L, Morsing A, Sundby Palle M, Vogl T, Loomba R, Plum-Morschel L. 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. Aliment Pharmacol Ther. 2021 Nov;54(9):1150-1161. doi: 10.1111/apt.16608. Epub 2021 Sep 27.
PubMed 34570916
Andersen 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.
PubMed 33006125

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Investigating the Effect of Subcutaneous Semaglutide on Liver Fibrosis Assessed by Magnetic Resonance Elastography in Subjects With Non-alcoholic Fatty Liver Disease
ClinicalTrials.gov ID: NCT03357380
Acronym / sponsor ID: NN9931-4381
Conditions: Hepatobiliary Disorders, Non-alcoholic Fatty Liver Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 28 Nov 2017 (actual)
Primary completion: 20 Mar 2020 (actual)
Study completion: 20 Mar 2020 (actual)
First posted: 29 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Semaglutide	Experimental	Drug: SemaglutideSemaglutide 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	Placebo comparator	Drug: PlaceboPlacebo 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SemaglutideSubcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.	Drug	Semaglutide
PlaceboSubcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.	Drug	Placebo

Primary outcome

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

30 secondary outcomes

Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Time frame: Up to day -20, week 24
Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Time frame: Up to day -20, week 72
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
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
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
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
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
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
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
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
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
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Time frame: Weeks 0 - 24
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Time frame: Weeks 0 - 48
Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)
Time frame: Weeks 0 - 72
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame: Up to day -20, week 24
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame: Up to day -20, week 48
Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame: Up to day -20, week 72
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame: Up to day -20, week 24
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame: Up to day -20, week 48
Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)
Time frame: Up to day -20, week 72
Change in Body weight (% and kg)
Time frame: Week 0, week 48
Change in Body weight (% and kg)
Time frame: Week 0, week 72
Change in Waist circumference
Time frame: Week 0, week 48
Change in Waist circumference
Time frame: Week 0, week 72
Change in Body mass index (BMI)
Time frame: Week 0, week 48
Change in Body mass index (BMI)
Time frame: Week 0, week 72
Number of treatment-emergent adverse events (TEAEs)
Time frame: Weeks 0 - 48
Number of treatment-emergent adverse events (TEAEs)
Time frame: Weeks 0 - 79
Number of treatment-emergent hypoglycaemic episodes
Time frame: Weeks 0 - 48
Number of treatment-emergent hypoglycaemic episodes
Time frame: Weeks 0 - 79

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
Results publication: PubMed 34570916Flint A, Andersen G, Hockings P, Johansson L, Morsing A, Sundby Palle M, Vogl T, Loomba R, Plum-Morschel L. 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. Aliment Pharmacol Ther. 2021 Nov;54(9):1150-1161. doi: 10.1111/apt.16608. Epub 2021 Sep 27.
Derived from this study: PubMed 33006125Andersen 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.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Reporting Anchor and Disclosure (1452) study director

Novo Nordisk A/S

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Semaglutide in people with Hepatobiliary Disorders and Non-alcoholic Fatty Liver Disease, run by Novo Nordisk A/S at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE) (time frame: Up to day -20, week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03357380, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.