NCT03357380

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

Completed Phase 1 Last updated 22 November 2021

What this trial tests

Phase 1 trial testing Semaglutide in Hepatobiliary Disorders in 67 participants. Completed in 20 March 2020.

Timeline

28 November 2017

Primary endpoint
20 March 2020

20 March 2020

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	67
Start date	28 November 2017
Primary completion	20 March 2020
Estimated completion	20 March 2020
Sites	2 locations across Germany

Drugs / interventions tested

• Semaglutide (semaglutide) — full drug profile →
• Placebo

Conditions studied

• Hepatobiliary Disorders — all drugs for Hepatobiliary Disorders →
• Non-alcoholic Fatty Liver Disease — all drugs for Non-alcoholic Fatty Liver Disease →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatobiliary Disorders or Non-alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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 A, Andersen G, Hockings P, Johansson L, et al · · 2021 · cited 168× · PMID 34570916 · DOI 10.1111/apt.16608
2. Future Perspectives on GLP-1 Receptor Agonists and GLP-1/glucagon Receptor Co-agonists in the Treatment of NAFLD.
   Seghieri M, Christensen AS, Andersen A, Solini A, et al · · 2018 · cited 61× · PMID 30459715 · DOI 10.3389/fendo.2018.00649
3. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for the management of nonalcoholic fatty liver disease (NAFLD): A systematic review.
   Lv X, Dong Y, Hu L, Lu F, et al · · 2020 · cited 42× · PMID 32704576 · DOI 10.1002/edm2.163
4. Recent Advancements in Antifibrotic Therapies for Regression of Liver Fibrosis.
   Jangra A, Kothari A, Sarma P, Medhi B, et al · · 2022 · cited 34× · PMID 35563807 · DOI 10.3390/cells11091500
5. Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD.
   Vitulo M, Gnodi E, Rosini G, Meneveri R, et al · · 2023 · cited 21× · PMID 37628929 · DOI 10.3390/ijms241612748
6. 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.
   Armstrong MJ, Okanoue T, Sundby Palle M, Sejling AS, et al · · 2025 · cited 13× · PMID 39609879 · DOI 10.1111/dom.16065
7. MAFLD Pandemic: Updates in Pharmacotherapeutic Approach Development.
   Khaznadar F, Khaznadar O, Petrovic A, Hefer M, et al · · 2024 · cited 10× · PMID 39057018 · DOI 10.3390/cimb46070376
8. New drug therapies for metabolic dysfunction-associated steatohepatitis.
   Chiang JYL. · · 2025 · cited 4× · PMID 40620497 · DOI 10.1016/j.livres.2025.01.001