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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: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT03166735 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The patient-specific plasma AOC3 activity at time t (24 hours after the last dose in week 12) relative to baseline in percentage was calculated as follows: %AOC3at = \[(AOC3at - AOC3at,back) ⁄ (AOC3abase - AOC3abase,back)\]\*100 With AOC3at the AOC3 activity measured at time t, AOC3at,back the background noise at time t, AOC3abase the AOC3 activity measured at baseline and AOC3abase,back the background noise at baseline. A dose-response relationship was analysed using a non-linear regression
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 |
What the finished NCT03166735 record still lists
NCT03166735 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03166735 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03166735's enrollment target sits among peer trials
114 627th of 2000 higher than 1,370 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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