GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criterion

•BMI 25-40

Primary endpoint

•Liver stiffness (kPa)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03357380

Org study IDNN9931-4381

Secondary ID2017-001193-42European Medicines Agency (EudraCT)

Secondary IDU1111-1194-3900World Health Organization (WHO)

Timeline

Milestones

Study start2017-11-28actual

Study first posted2017-11-29actual

Primary completion2020-03-20actual

Study completion2020-03-20actual

Last update posted2021-11-22actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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)

Endpoints (31)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver

Weight & body composition

Safety / tolerability / PK

Weight & body composition

12 endpoints

Secondary/protocol endpoint

Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)

Time frame:Up to day -20, week 24

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)

Time frame:Up to day -20, week 48

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)

Time frame:Up to day -20, week 72

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)

Time frame:Up to day -20, week 24

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)

Time frame:Up to day -20, week 48

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)

Time frame:Up to day -20, week 72

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body weight (% and kg)

Time frame:Week 0, week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body weight (% and kg)

Time frame:Week 0, week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Waist circumference

Time frame:Week 0, week 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist circumference

Time frame:Week 0, week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body mass index (BMI)

Time frame:Week 0, week 48

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body mass index (BMI)

Time frame:Week 0, week 72

BMI, change

change from baseline, improvement

MASH / liver

15 endpoints

Primary/protocol endpoint

Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)

Time frame:Up to day -20, week 48

change from baseline, improvement

Secondary/protocol endpoint

Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)

Time frame:Up to day -20, week 24

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)

Time frame:Up to day -20, week 72

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

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

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

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

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

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

MRI-PDFF ≥30% responders

threshold achievement, improvement

Secondary/protocol endpoint

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

MRI-PDFF ≥30% responders

threshold achievement, improvement

Secondary/protocol endpoint

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

MRI-PDFF ≥30% responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)

Time frame:Weeks 0 - 24

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)

Time frame:Weeks 0 - 48

Liver stiffness (VCTE), change

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)

Time frame:Weeks 0 - 72

threshold achievement, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of treatment-emergent adverse events (TEAEs)

Time frame:Weeks 0 - 48

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment-emergent adverse events (TEAEs)

Time frame:Weeks 0 - 79

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment-emergent hypoglycaemic episodes

Time frame:Weeks 0 - 48

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of treatment-emergent hypoglycaemic episodes

Time frame:Weeks 0 - 79

Documented hypoglycemia

event count, event

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Similar weight loss with semaglutide regardless of diabetes and cardiometabolic risk parameters in individuals with metabolic dysfunction-associated steatotic liver disease: Post hoc analysis of three randomised controlled trials.
Diabetes, obesity & metabolism2025 Feb (month)PMID39609879doi:10.1111/dom.16065via pubmed nct search
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.
Alimentary pharmacology & therapeutics2021 Nov (month)PMID34570916doi:10.1111/apt.16608via CT.gov reference + pubmed nct search
Clinical Characteristics of a Non-Alcoholic Fatty Liver Disease Population Across the Fibrosis Spectrum Measured by Magnetic Resonance Elastography: Analysis of Screening Data.
Advances in therapy2020 Dec (month)PMID33006125doi:10.1007/s12325-020-01503-xvia clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.