Nonalcoholic Steatohepatitis (NASH)Phase 2NCT02854605
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study testing GS-9674 in people with Nonalcoholic Steatohepatitis (NASH), run by Gilead Sciences at 37 sites in 6 countries.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH)
- What is being tested?
- GS-9674
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 37 sitesin 6 countries
- Study dates
- 26 Oct 2016to 9 Jan 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the following conditions:
- A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
- Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
- Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kilopascal (kPa) OR
- A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
- No documented weight loss > 5% between the date of the liver biopsy and screening.
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- Platelet count ≥ 150,000/mm^3
- Albumin ≥ 3.3 g/dL
- Serum creatinine ≤ upper limit of normal (ULN)
Who cannot join
- Pregnant or lactating females
- Alanine aminotransferase (ALT) > 5x upper limit of the normal range (ULN)
- Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
- Cirrhosis of the liver
- Prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding
- Body mass index (BMI) < 18 kg/m^2
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- Uncontrolled diabetes mellitus (hemoglobin A1c > 9% at screening)
- International normalized ratio (INR) > 1.2 unless on anticoagulant therapy
- Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
United States26 sites
Texas Clinical Research Institute
Arlington, Texas, 76012
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308
Northwestern Memorial Hospital, Clinical Research Unit
Chicago, Illinois, 60611
Clinical Research of South Florida
Coral Gables, Florida, 33134
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
Texas Digestive Disease Consultants
Dallas, Texas, 75246
Duke University Medical Center, Duke South Clinics
Durham, North Carolina, 27710
Carolinas Center for Liver Disease/Carolinas HealthCare System
Durham, North Carolina, 28078
Gastro One
Germantown, Tennessee, 38138
Houston Methodist Hospital
Houston, Texas, 77030
Kansas City Research Institute
Kansas City, Missouri, 64131
Pinnacle Clinical Research
Live Oak, Texas, 78233
Ruane Clinical Research Group Inc.
Los Angeles, California, 90036
Cedars Sinai Medical Center
Los Angeles, California, 90048
Crescent Clinical Research Center, LLC
Metairie, Louisiana, 70006
Intermountain Liver Disease and Transplant Center
Murray, Utah, 84107
Quality Medical Research, PC
Nashville, Tennessee, 37211
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Concorde Medical Group, PLLC
New York, New York, 10016
Bon Secours St. Mary's Hospital of Richmond, Inc d/b/a Bon Secours Liver Institute of Virginia
Newport News, Virginia, 23602
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Inland Empire Liver Foundation
Rialto, California, 92377
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
Richmond, Virginia, 23226
McGuire VA Medical Center
Richmond, Virginia, 23249
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
Swedish Organ Transplant and Liver Center
Seattle, Washington, 98104
Canada5 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
LMC Clinical Research Inc (Bayview)
Toronto, Ontario, M4G 3E8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Toronto Liver Center
Toronto, Ontario, M6H 3M1
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4Y7
Hong Kong2 sites
Princess Margaret Hospital
Kowloon
The Chinese University of Hong Kong
Shatin
Switzerland2 sites
Universitatsspital Bern, Inselspital, Universitatsklinik fur Viszerale Chirurgie und Medizin, Hepatologie
Bern, 3010
Universitatsspital Zurich
Zurich, CH-8091
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- GS-9674, Placebo to match GS-9674
- Keywords
- Non-alcoholic fatty liver disease (NAFLD), Fibrosis, GS-9674
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-9674Drug
Tablet administered orally once daily
Placebo to match GS-9674Drug
Tablet(s) administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| GS-9674 30 mg | Experimental | GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks Receives: Drug: GS-9674; Drug: Placebo to match GS-9674 |
| GS-9674 100 mg | Experimental | GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks Receives: Drug: GS-9674; Drug: Placebo to match GS-9674 |
| Placebo | Placebo comparator | Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks Receives: Drug: Placebo to match GS-9674 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.
Measured: Up to 24 weeks plus 30 days
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.
Measured: Up to 24 weeks plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start26 Oct 2016
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
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 Steatohepatitis (NASH)Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854605
- Sponsor's protocol ID
- GS-US-402-1852
- Other IDs
- 2016-002496-10, 2016
- Status last verified
- Jan 2019
- First submitted
- 29 Jul 2016
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Patel K, Harrison SA, Elkhashab M, Trotter JF, Herring R, Rojter SE, Kayali Z, Wong VW, Greenbloom S, Jayakumar S, Shiffman ML, Freilich B, Lawitz EJ, Gane EJ, Harting E, Xu J, Billin AN, Chung C, Djedjos CS, Subramanian GM, Myers RP, Middleton MS, Rinella M, Noureddin M. Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial. Hepatology. 2020 Jul;72(1):58-71. doi: 10.1002/hep.31205.
PubMed 32115759
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT02854605
- Acronym / sponsor ID
- GS-US-402-1852
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Keywords
- Non-alcoholic fatty liver disease (NAFLD), Fibrosis, GS-9674
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Posted 29 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GS-9674 30 mg | Experimental | Drug: GS-9674, Drug: Placebo to match GS-9674GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks |
| GS-9674 100 mg | Experimental | Drug: GS-9674, Drug: Placebo to match GS-9674GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks |
| Placebo | Placebo comparator | Drug: Placebo to match GS-9674Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meets the following conditions:
- Platelet count ≥ 150,000/mm^3
- Albumin ≥ 3.3 g/dL
- Serum creatinine ≤ upper limit of normal (ULN)
Key exclusion criteria (10 listed)
- Pregnant or lactating females
- Alanine aminotransferase (ALT) > 5x upper limit of the normal range (ULN)
- Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
- Cirrhosis of the liver
- Body mass index (BMI) < 18 kg/m^2
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 |
|---|---|---|
| GS-9674Tablet administered orally once daily | Drug | GS-9674 100 mg, GS-9674 30 mg |
| Placebo to match GS-9674Tablet(s) administered orally once daily | Drug | GS-9674 100 mg, GS-9674 30 mg, Placebo |
Primary outcome
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 24 weeks plus 30 days
TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Time frame: Up to 24 weeks plus 30 days
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32115759Patel K, Harrison SA, Elkhashab M, Trotter JF, Herring R, Rojter SE, Kayali Z, Wong VW, Greenbloom S, Jayakumar S, Shiffman ML, Freilich B, Lawitz EJ, Gane EJ, Harting E, Xu J, Billin AN, Chung C, Djedjos CS, Subramanian GM, Myers RP, Middleton MS, Rinella M, Noureddin M. Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial. Hepatology. 2020 Jul;72(1):58-71. doi: 10.1002/hep.31205.
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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.
Gilead Study Director study director
Gilead Sciences
37 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS-9674 in people with Nonalcoholic Steatohepatitis (NASH), run by Gilead Sciences at 37 sites in 6 countries.
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 9 inclusion and 10 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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada, Hong Kong, Switzerland, New Zealand and 1 more country. 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 29 Jan 2019). 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?
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 24 weeks plus 30 days). 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 NCT02854605, 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 29 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.