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NCT03987451 · ClinicalTrials.gov registry record · Phase 2
A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage
A Phase 2 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT03987451: Completed Phase 2 study, sponsored by Novo Nordisk A/S.
NCT03987451 is a Phase 2 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03987451, a Phase 2 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. Some of the clinic visits may be spread over more days. Participants will need to inject themselves with medicine under the skin. Participants will have to do this once a week for 48 weeks. The study includes magnetic resonance imaging (MRI) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. For some tests participants may need to remove some items of clothing. Participants will stop in the study if the doctor thinks that there are any risks for their health. The information collected from participants during the study may help them and other patients with NASH in the future. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Primary Outcome
NASH resolution defined by NASH clinical research network (CRN) as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, higher scores indicating more severe hepatocellular ballooning/lobular inflammation. Worsening of NASH defined by NASH CRN as increase of at least 1 stage of either lobular inflammation, hepatocyte ballooning or steatosis. Worsening of fib
Interventions
- DRUG Semaglutide
- DRUG Placebo (semaglutide)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2019-06-18 |
| Est. Completion | 2021-06-10 |
| Phase | Phase 2 |
What the finished NCT03987451 record still lists
NCT03987451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Semaglutide is the first listed.
NCT03987451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03987451 about?
NCT03987451 is a clinical study titled "A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage". Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Pa...
What is the current status of trial NCT03987451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2019-06-18. Estimated completion is 2021-06-10.
What interventions are being tested in trial NCT03987451?
The interventions under investigation include: Semaglutide (DRUG), Placebo (semaglutide) (DRUG).
Who is sponsoring clinical trial NCT03987451?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03987451's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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