Trial · NCT05282121
A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
NCT05282121, Phase 2, Terminated, Boehringer Ingelheim; results first posted 2025-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver). Trials, record NCT05282121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05282121
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
- NCT number
- NCT05282121
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Liver Diseases, Hypertension, Portal
- Interventions
- Avenciguat, Empagliflozin
- First posted
- 2022-03-16
- Last updated
- 2025-09-04
- Other registries' IDs
- eudract:2021-005171-40
- Results first posted
- 2025-04-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in HVPG From Baseline (Measured in mmHg) After 8 Weeks of Treatment | Before the first intake of trial medication (baseline), and after 8 weeks of treatment. | Percentage change in Hepatic Venous Pressure Gradient (HVPG) from baseline (measured in millimetre of mercury \[mmHg\]) after 8 weeks of treatment is reported. Adjusted mean (Least Square Mean) was calculated using an analysis of covariance (ANCOVA) model without imputing the missing data. The model included treatment as fixed classification effects, and baseline HVPG as a linear covariate. The random error was assumed to be normally distributed with mean 0 and variance σ². |
| Secondary | Occurrence of a Response, Which is Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Before the first intake of trial medication (baseline), and after 8 weeks of treatment. | Occurrence of a response, which is defined as \> 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment is reported. |
| Secondary | Occurrence of One or More Decompensation Events (i.e. Ascites, VH, and / or Overt HE) During the 8-week Treatment Period | From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks. | Occurrence of one or more decompensation events (i.e. ascites, Variceal Haemorrhage \[VH\], and / or overt Hepatic Encephalopathy \[HE\]) during the 8-week treatment period is reported. |
| Secondary | Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement, During the 8-week Treatment Period | From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks. | Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8-week treatment period is reported. The CTCAE grades are: 1 (mild Adverse Event \[AE\]), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE). |
| Secondary | Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment Period | From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks. | Occurrence of discontinuation of treatment with avenciguat due to hypotension or syncope during the 8-week treatment period is reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in HVPG From Baseline (Measured in mmHg) After 8 Weeks of Treatment | Before the first intake of trial medication (baseline), and after 8 weeks of treatment. | Full analysis set (FAS): this analysis set includes all enrolled or randomised patients who received at least one dose of trial medication and have a baseline measurement for the primary endpoint recorded. | Percentage of change in HVPG | LEAST_SQUARES_MEAN |
| SECONDARY | Occurrence of a Response, Which is Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Before the first intake of trial medication (baseline), and after 8 weeks of treatment. | Full analysis set (FAS): this analysis set includes all enrolled or randomised patients who received at least one dose of trial medication and have a baseline measurement for the primary endpoint recorded. Only patients with a HVPG measurement at week 8 are reported. | Count of participants | NUMBER |
| SECONDARY | Occurrence of One or More Decompensation Events (i.e. Ascites, VH, and / or Overt HE) During the 8-week Treatment Period | From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks. | Treated set (TS): all patients who were enrolled or randomised to the trial medication and were treated with at least one dose of trial medication. | Count of participants | NUMBER |
| SECONDARY | Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement, During the 8-week Treatment Period | From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks. | Treated set (TS): all patients who were enrolled or randomised to the trial medication and were treated with at least one dose of trial medication. | Count of participants | NUMBER |
| SECONDARY | Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment Period | From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks. | Treated set (TS): all patients who were enrolled or randomised to the trial medication and were treated with at least one dose of trial medication. | Count of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in HVPG From Baseline (Measured in mmHg) After 8 Weeks of Treatment | Patients With HBV - Avenciguat | -16.06 | Standard Error 6.66 | Percentage of change in HVPG | |
| Percentage Change in HVPG From Baseline (Measured in mmHg) After 8 Weeks of Treatment | Patients With HCV - Avenciguat | -5.81 | Standard Error 7.09 | Percentage of change in HVPG | |
| Percentage Change in HVPG From Baseline (Measured in mmHg) After 8 Weeks of Treatment | Patients With NASH With or Without T2DM - Avenciguat | 3.83 | Standard Error 4.25 | Percentage of change in HVPG | |
| Percentage Change in HVPG From Baseline (Measured in mmHg) After 8 Weeks of Treatment | Patients With NASH With T2DM - Avenciguat + Empagliflozin | 3.27 | Standard Error 5.08 | Percentage of change in HVPG | |
| Occurrence of a Response, Which is Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Patients With HBV - Avenciguat | 9 | Count of participants | ||
| Occurrence of a Response, Which is Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Patients With HCV - Avenciguat | 2 | Count of participants | ||
| Occurrence of a Response, Which is Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Patients With NASH With or Without T2DM - Avenciguat | 9 | Count of participants | ||
| Occurrence of a Response, Which is Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Patients With NASH With T2DM - Avenciguat + Empagliflozin | 4 | Count of participants | ||
| Occurrence of One or More Decompensation Events (i.e. Ascites, VH, and / or Overt HE) During the 8-week Treatment Period | Patients With HBV - Avenciguat | 1 | Count of participants | ||
| Occurrence of One or More Decompensation Events (i.e. Ascites, VH, and / or Overt HE) During the 8-week Treatment Period | Patients With HCV - Avenciguat | 0 | Count of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients With HBV - Avenciguat | 14 | |
| Overall Study | STARTED | Patients With HCV - Avenciguat | 13 | |
| Overall Study | STARTED | Patients With NASH With or Without T2DM - Avenciguat | 38 | |
| Overall Study | STARTED | Patients With NASH With T2DM - Avenciguat + Empagliflozin | 25 | |
| Overall Study | COMPLETED | Patients With HBV - Avenciguat | 12 | |
| Overall Study | COMPLETED | Patients With HCV - Avenciguat | 10 | |
| Overall Study | COMPLETED | Patients With NASH With or Without T2DM - Avenciguat | 30 | |
| Overall Study | COMPLETED | Patients With NASH With T2DM - Avenciguat + Empagliflozin | 22 | |
| Overall Study | NOT COMPLETED | Patients With HBV - Avenciguat | 2 | |
| Overall Study | NOT COMPLETED | Patients With HCV - Avenciguat | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events164
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pericardial effusion | Cardiac disorders | Patients With HBV - Avenciguat | 1 | 14 | |
| other | Pericardial effusion | Cardiac disorders | Patients With HCV - Avenciguat | 0 | 13 | |
| other | Pericardial effusion | Cardiac disorders | Patients With NASH With or Without T2DM - Avenciguat | 0 | 38 | |
| other | Pericardial effusion | Cardiac disorders | Patients With NASH With T2DM - Avenciguat + Empagliflozin | 0 | 25 | |
| other | Dry eye | Eye disorders | Patients With HBV - Avenciguat | 1 | 14 | |
| other | Dry eye | Eye disorders | Patients With HCV - Avenciguat | 0 | 13 | |
| other | Dry eye | Eye disorders | Patients With NASH With or Without T2DM - Avenciguat | 0 | 38 | |
| other | Dry eye | Eye disorders | Patients With NASH With T2DM - Avenciguat + Empagliflozin | 0 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Patients With HBV - Avenciguat | 1 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | Patients With HCV - Avenciguat | 0 | 13 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With HBV - Avenciguat | 0 | 14 |
| Total, all-cause mortality | Patients With HCV - Avenciguat | 0 | 13 |
| Total, all-cause mortality | Patients With NASH With or Without T2DM - Avenciguat | 0 | 38 |
| Total, all-cause mortality | Patients With NASH With T2DM - Avenciguat + Empagliflozin | 0 | 25 |
| Total, other adverse events | Patients With HBV - Avenciguat | 12 | 14 |
| Total, other adverse events | Patients With HCV - Avenciguat | 5 | 13 |
| Total, other adverse events | Patients With NASH With or Without T2DM - Avenciguat | 16 | 38 |
| Total, other adverse events | Patients With NASH With T2DM - Avenciguat + Empagliflozin | 13 | 25 |
| Total, serious adverse events | Patients With HBV - Avenciguat | 1 | 14 |
| Total, serious adverse events | Patients With HCV - Avenciguat | 2 | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37095557 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05282121
GET https://conductscience.org/api/trials/v1/NCT05282121/events?page=2