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NCT05016882 · ClinicalTrials.gov registry record · Phase 2
Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 698
- Enrollment target
NCT05016882: Completed Phase 2 study, sponsored by Novo Nordisk A/S.
NCT05016882 is a Phase 2 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 698 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (425% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05016882, a Phase 2 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 698 participants
- Enrollment target
Study Summary
This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH). NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own. The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH. Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine. The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor. Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment. Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Primary Outcome
Count of subjects Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale
Interventions
- DRUG Semaglutide placebo
- DRUG NNC0194 0499 50 mg/mL
- DRUG Placebo (NNC0194-0499)
- DRUG Semaglutide 3 mg/mL
- DRUG NNC0174 0833 10 mg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 698 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2025-03-14 |
| Phase | Phase 2 |
What the finished NCT05016882 record still lists
NCT05016882 is an interventional study that assigns participants to a tested intervention. The registered 698 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (425% higher).
The record links to 0 conditions, and to 5 interventions - of which Semaglutide placebo is the first listed.
NCT05016882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05016882 about?
NCT05016882 is a clinical study titled "Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)". This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH). NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used b...
What is the current status of trial NCT05016882?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 698 participants. The study started on 2021-08-31. Estimated completion is 2025-03-14.
What interventions are being tested in trial NCT05016882?
The interventions under investigation include: Semaglutide placebo (DRUG), NNC0194 0499 50 mg/mL (DRUG), Placebo (NNC0194-0499) (DRUG), Semaglutide 3 mg/mL (DRUG), NNC0174 0833 10 mg/mL (DRUG).
Who is sponsoring clinical trial NCT05016882?
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 NCT05016882's enrollment target sits among peer trials
698 46th of 2000 higher than 1,955 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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