Trial · NCT02077374
A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
NCT02077374, Phase 2, Completed, Conatus Pharmaceuticals Inc.; results first posted 2016-07-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases. Trials, record NCT02077374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02077374
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
- NCT number
- NCT02077374
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Conditions
- Nonalcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
- Interventions
- IDN-6556, Placebo
- First posted
- 2014-03-04
- Last updated
- 2016-08-30
- Results first posted
- 2016-07-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Alanine Aminotransferase (ALT) | Day 28/ET | Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo |
| Primary | Relative Percent Change in Alanine Aminotransferase (ALT) | Baseline to Day 28/ET | Back transformation from log-transformed analysis results to original scale in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo |
| Secondary | Change in Aspartate Aminotransferase (AST) | Day 28/ET | Difference in the change in aspartate aminotransferase (AST) from Baseline to Day 28/ET in units per liter (U/L) between IDN-6556 and placebo. |
| Secondary | Levels of cCK18/M30 | Day 28/ET | Difference in the change in Caspase-cleaved cytokeratin serum levels (cCK18/M30) in units per liter (U/L) from baseline to Day 28/ET between IDN-6556 and placebo |
| Secondary | Levels of Caspase 3/7 RLU | Day 28/ET | Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo |
| Secondary | Levels of flCK18/M65 | Day 28/ET | Difference in the change in full-length cytokeratin 18 (flCK18/M65) in units per liter (U/L) from Baseline to Day 28/ET between IDN-6556 and placebo |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Alanine Aminotransferase (ALT) | Day 28/ET | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | U/L | MEAN |
| PRIMARY | Relative Percent Change in Alanine Aminotransferase (ALT) | Baseline to Day 28/ET | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | Relative percent change | MEAN |
| SECONDARY | Change in Aspartate Aminotransferase (AST) | Day 28/ET | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | U/L | MEDIAN |
| SECONDARY | Levels of cCK18/M30 | Day 28/ET | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | U/L | MEDIAN |
| SECONDARY | Levels of Caspase 3/7 RLU | Day 28/ET | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | RLU | MEDIAN |
| SECONDARY | Levels of flCK18/M65 | Day 28/ET | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | U/L | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Alanine Aminotransferase (ALT) | IDN-6556 | -37.8 | Standard Deviation 42.7 | U/L | |
| Change in Alanine Aminotransferase (ALT) | Placebo | -14.9 | Standard Deviation 22.5 | U/L | |
| Relative Percent Change in Alanine Aminotransferase (ALT) | IDN-6556 | -39.2 | Standard Deviation 26.2 | Relative percent change | |
| Relative Percent Change in Alanine Aminotransferase (ALT) | Placebo | -13.9 | Standard Deviation 21.8 | Relative percent change | |
| Change in Aspartate Aminotransferase (AST) | IDN-6556 | -6.7 | Full Range -63.1 to 20.0 | U/L | |
| Change in Aspartate Aminotransferase (AST) | Placebo | -5.2 | Full Range -41.9 to 27.9 | U/L | |
| Levels of cCK18/M30 | IDN-6556 | -183.0 | Full Range -640 to 190 | U/L | |
| Levels of cCK18/M30 | Placebo | 14.0 | Full Range -2056 to 571 | U/L | |
| Levels of Caspase 3/7 RLU | IDN-6556 | -287.0 | Full Range -2194 to 417 | RLU | |
| Levels of Caspase 3/7 RLU | Placebo | 68.0 | Full Range -1779 to 1229 | RLU |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IDN-6556 | 19 | |
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | COMPLETED | IDN-6556 | 19 | |
| Overall Study | COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | IDN-6556 | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events74
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 | Haemorrhagic anaemia | Blood and lymphatic system disorders | IDN-6556 | 0 | 19 | 0 |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Placebo | 1 | 19 | 1 |
| other | Hyperthyroidism | Endocrine disorders | IDN-6556 | 1 | 19 | 1 |
| other | Hyperthyroidism | Endocrine disorders | Placebo | 0 | 19 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | IDN-6556 | 0 | 19 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 1 | 19 | 1 |
| other | Frequent bowel movements | Gastrointestinal disorders | IDN-6556 | 2 | 19 | 2 |
| other | Frequent bowel movements | Gastrointestinal disorders | Placebo | 0 | 19 | 0 |
| other | Chest pain | General disorders | IDN-6556 | 2 | 19 | 2 |
| other | Chest pain | General disorders | Placebo | 0 | 19 | 0 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IDN-6556 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | IDN-6556 | 10 | 19 |
| Total, other adverse events | Placebo | 8 | 19 |
| Total, serious adverse events | IDN-6556 | 1 | 19 |
| Total, serious adverse events | Placebo | 1 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30430605 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| IDN-6556 vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT02077374
GET https://conductscience.org/api/trials/v1/NCT02077374/events?page=2