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NCT03166735 · ClinicalTrials.gov registry record · Phase 2
Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT03166735 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 114 participants.
The verdict
NCT03166735, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study Summary
The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to NASH and liver fibrosis will be performed. This will include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key information regarding the use of BI 1467335 in patients with NASH.
Interventions
- DRUG Placebo
- DRUG BI 1467335
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2017-06-06 |
| Est. Completion | 2019-06-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03166735
The ClinicalTrials.gov registry entry for NCT03166735 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03166735 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03166735 about?
NCT03166735 is a clinical study titled "Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH". The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to N...
What is the current status of trial NCT03166735?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2017-06-06. Estimated completion is 2019-06-14.
What interventions are being tested in trial NCT03166735?
The interventions under investigation include: Placebo (DRUG), BI 1467335 (DRUG).
Who is sponsoring clinical trial NCT03166735?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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