Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH
Public ClinicalTrials.gov record NCT03166735. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-centre, Double-blind, Parallel-group, Randomised, Placebo Controlled Phase II a Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Different Doses of Orally Administered BI 1467335 During a 12-week Treatment Period Compared to Placebo in Patients With Clinical Evidence of NASH.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03166735
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 114 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 5, 2017
- Primary completion
- Jun 13, 2019
- Completion
- Jun 13, 2019
- Last update posted
- Jun 10, 2020
2017 – 2019
United States locations
- U.S. sites
- 17
- U.S. states
- 7
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Research Center | Coronado | California | 92118 | — |
| University of California San Diego | La Jolla | California | 92037 | — |
| eStudySite | La Mesa | California | 91942 | — |
| National Research Institute | Los Angeles | California | 90057 | — |
| National Research Institute | Los Angeles | California | 90255 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | — |
| Genoma Research Group, Inc | Miami | Florida | 33165 | — |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| Northwell Health | Manhasset | New York | 11030 | — |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Diabetes and Endocrinology Consultants, PC | Morehead City | North Carolina | 28557 | — |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | — |
| Pinnacle Clinical Research | Live Oak | Texas | 78233 | — |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03166735, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2020 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03166735 live on ClinicalTrials.gov.