Nonalcoholic SteatohepatitisPhase 2NAFLDNCT02077374
A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
A Phase 2 study testing IDN-6556 in people with Nonalcoholic Steatohepatitis and Non-alcoholic Fatty Liver Disease, run by Conatus Pharmaceuticals Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
- What is being tested?
- IDN-6556
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2014to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
- Diagnosis of non-alcoholic fatty liver disease (NAFLD) as evidenced by imaging or other diagnostic assessments
- Alanine aminotransferase (ALT) levels ≥1.5 x ULN on at least two occasions, seven or more days apart, during the Screening period
- alpha-fetoprotein (AFP) ≤ 100 ng/mL
- Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 10^9/L, and a white blood cell count ≥ 3.0 x 10^9/L
- If on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to Screening and during the study
Who cannot join
- Known infection with HIV, HCV, or HBV
- Decompensated or severe liver disease as evidenced by one or more of the following:
- Confirmed cirrhosis or suspicion of cirrhosis
- Esophageal varices
- Ascites
- Suspicion of portal hypertension
Show all 14Show fewer
- Hospitalization for liver disease within 60 days of screening
- Bilirubin >2 x ULN, or ALT or AST > 10 x ULN
- Inflammatory bowel disease
- Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
- Hepatocellular carcinoma (HCC) at entry into the study
- History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
- Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, and/or serious psychiatric disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study
- History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 4-ounce glasses of wine or 14 12-ounce cans/bottles of beer or wine coolers), or other substance abuse within the prior two years
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Henry Ford Hospital
Detroit, Michigan, 48202
Indiana University
Indianapolis, Indiana, 46202
Kansas City Research Institute
Kansas City, Missouri, 64131
University of Miami
Miami, Florida, 33136
Mary Immaculate Hospital
Newport News, Virginia, 23602
Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects With Non-Alcoholic Fatty Liver Disease and Raised Transaminases
The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests
Read the detailed description
This is a double-blind, randomized study to evaluate the effects of IDN-6556 on serum transaminases and pharmacodynamics of IDN-6556 in subjects with non-alcoholic fatty liver disease with elevated alanine aminotransferase.
- Being tested
- IDN-6556, Placebo
- Keywords
- NAFLD, NASH
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDN-6556Drug
Also called emricasan, PF-03491390
25 mg BID for 28 days
PlaceboOther
Placebo BID for 28 Days
| Study group | Role | What they receive |
|---|---|---|
| IDN-6556 | Experimental | IDN-6556 capsules, 25 mg BID Receives: Drug: IDN-6556 |
| Placebo | Placebo comparator | Placebo BID Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alanine Aminotransferase (ALT)
Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo
Measured: Day 28/ET
Relative Percent Change in Alanine Aminotransferase (ALT)
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
Measured: Baseline to Day 28/ET
Secondary outcomes (4)
Change in Aspartate Aminotransferase (AST)
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.
Measured: Day 28/ET
Levels of cCK18/M30
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
Measured: Day 28/ET
Levels of Caspase 3/7 RLU
Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo
Measured: Day 28/ET
Levels of flCK18/M65
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
Measured: Day 28/ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean L. Chan, MD, Study director, Conatus Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077374
- Sponsor's protocol ID
- IDN-6556-06
- Acronym
- NAFLD
- Status last verified
- Jul 2016
- First submitted
- 28 Feb 2014
- Last updated
- 30 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shiffman M, Freilich B, Vuppalanchi R, Watt K, Chan JL, Spada A, Hagerty DT, Schiff E. Randomised clinical trial: emricasan versus placebo significantly decreases ALT and caspase 3/7 activation in subjects with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2019 Jan;49(1):64-73. doi: 10.1111/apt.15030. Epub 2018 Nov 14.
PubMed 30430605
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects With Non-Alcoholic Fatty Liver Disease and Raised Transaminases
- ClinicalTrials.gov ID
- NCT02077374
- Acronym / sponsor ID
- NAFLD / IDN-6556-06
- Keywords
- NAFLD, NASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Conatus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Posted 21 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests
Detailed description
This is a double-blind, randomized study to evaluate the effects of IDN-6556 on serum transaminases and pharmacodynamics of IDN-6556 in subjects with non-alcoholic fatty liver disease with elevated alanine aminotransferase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDN-6556 | Experimental | Drug: IDN-6556IDN-6556 capsules, 25 mg BID |
| Placebo | Placebo comparator | Other: PlaceboPlacebo BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
- Diagnosis of non-alcoholic fatty liver disease (NAFLD) as evidenced by imaging or other diagnostic assessments
- Alanine aminotransferase (ALT) levels ≥1.5 x ULN on at least two occasions, seven or more days apart, during the Screening period
- alpha-fetoprotein (AFP) ≤ 100 ng/mL
- Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 10^9/L, and a white blood cell count ≥ 3.0 x 10^9/L
Key exclusion criteria (14 listed)
- Known infection with HIV, HCV, or HBV
- Decompensated or severe liver disease as evidenced by one or more of the following:
- Inflammatory bowel disease
- Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
- Hepatocellular carcinoma (HCC) at entry into the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDN-6556Also: emricasan, PF-0349139025 mg BID for 28 days | Drug | IDN-6556 |
| PlaceboPlacebo BID for 28 Days | Other | Placebo |
Primary outcome
Change in Alanine Aminotransferase (ALT)
Time frame: Day 28/ET
Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo
Relative Percent Change in Alanine Aminotransferase (ALT)
Time frame: 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
4 secondary outcomes
Change in Aspartate Aminotransferase (AST)
Time frame: Day 28/ET
Levels of cCK18/M30
Time frame: Day 28/ET
Levels of Caspase 3/7 RLU
Time frame: Day 28/ET
Levels of flCK18/M65
Time frame: Day 28/ET
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30430605Shiffman M, Freilich B, Vuppalanchi R, Watt K, Chan JL, Spada A, Hagerty DT, Schiff E. Randomised clinical trial: emricasan versus placebo significantly decreases ALT and caspase 3/7 activation in subjects with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2019 Jan;49(1):64-73. doi: 10.1111/apt.15030. Epub 2018 Nov 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean L. Chan, MD study director
Conatus Pharmaceuticals Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IDN-6556 in people with Nonalcoholic Steatohepatitis and Non-alcoholic Fatty Liver Disease, run by Conatus Pharmaceuticals Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alanine Aminotransferase (ALT) (time frame: Day 28/ET). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02077374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.