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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 is a Phase 2 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 698 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05016882
The ClinicalTrials.gov registry entry for NCT05016882 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 698 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Semaglutide placebo is the first listed.
NCT05016882 reports 0 study locations.
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.
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