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NCT04065841 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 234
- Enrollment target
NCT04065841: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04065841 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 234 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04065841, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 234 participants
- Enrollment target
Study Summary
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
Primary Outcome
Response was defined as at least a one-stage improvement in fibrosis without worsening of nonalcoholic steatohepatitis (NASH) Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and perip
Interventions
- OTHER Placebo
- DRUG Tropifexor
- DRUG Licogliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2019-12-30 |
| Est. Completion | 2022-10-27 |
| Phase | Phase 2 |
Why NCT04065841 stopped before completion
NCT04065841 is an interventional study that assigns participants to a tested intervention. The registered 234 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 (76% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04065841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04065841 about?
NCT04065841 is a clinical study titled "Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.". Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
What is the current status of trial NCT04065841?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2019-12-30. Estimated completion is 2022-10-27.
What interventions are being tested in trial NCT04065841?
The interventions under investigation include: Placebo (OTHER), Tropifexor (DRUG), Licogliflozin (DRUG).
Who is sponsoring clinical trial NCT04065841?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04065841's enrollment target sits among peer trials
234 255th of 2000 higher than 1,745 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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