Nonalcoholic Steatohepatitis (NASH)Phase 2NCT05591079
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH
A Phase 2 study testing CS0159 (Linafexor) in people with Nonalcoholic Steatohepatitis (NASH), run by Cascade Pharmaceuticals, Inc at 17 sites in United States.
Trial summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic 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?
- CS0159 (Linafexor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 17 sitesUnited States
- Study dates
- 10 Feb 2023to 9 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients who meet the diagnosis of NASH.
- Evidence of metabolic syndrome, except for those patients with biopsy-proven NASH.
- Body mass index (BMI) >25 kg/m2, NOTE: for Asian-Americans BMI >23 kg/m2.
- Stable use of other antidiabetic, weight loss, or lipid-modifying medications for at least 12 weeks prior to randomization.
Who cannot join
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
- Previous exposure to farnesoid X receptor (FXR) agonists 3 months prior to the first dosing.
- Current or within 6 months of screening use of drugs associated with steatosis, including but not limited to eg, methotrexate, amiodarone, high-dose estrogen, tamoxifen, long term systemic steroids, anabolic steroids, valproic acid.
- Prothrombin time international normalized ratio >1.3, unless due to therapeutic anticoagulation.
- Total bilirubin >upper limit of normal (ULN; except for patients with Gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count).
- Platelet count <140 000/mm³, absolute neutrophil count <1500 cells/mm3, or total
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- white blood cells <3000 cells/mm3.
- Alanine aminotransferase and aspartate aminotransferase (AST) >5 × ULN, or alkaline phosphatase (ALP) >1.5 × ULN.
- Weight changes >10% in 6 months prior to screening, or weight changes >5% from the screening MRI-PDFF to randomization or from the time of the diagnostic liver biopsy to randomization, whichever is longer.
- Poorly controlled hypertension (systolic >160 mm Hg, or diastolic blood pressure >100 mm Hg - mean of 3 measurements).
- Uncontrolled diabetes mellitus (hemoglobin A1c >10.0% during screening).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Texas Liver Institute (TLI) - Austin
Austin, Texas, 78757-7571
Oracle Clinical Research
College Park, Georgia, 30349
National Research Institute - Gardena
Gardena, California, 90247-3586
Raja M. Din MD, PLLC - Gastroenterology & Hepatology
Greenbelt, Maryland, 20770-6702
Pioneer Research Solutions Inc - Houston - Stancliff Rd
Houston, Texas, 77099-4307
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255-2959
Ocala GI Research
Lady Lake, Florida, 32159
Florida Research Institute
Lakewood, Florida, 34211-4930
Metropolitan Gastroenterology Associates - Westbank Office and Endoscopy
Marrero, Louisiana, 70072
San Marcus Research Clinic, Inc - Miami
Miami, Florida, 33014-5602
Floridian Clinical Research, LLC - Miami Lakes
Miami Lakes, Florida, 33016-1518
Lucas Research
Morehead City, North Carolina, 28557
Gastroenterology Associates of Ocala
Ocala, Florida, 34471
Velocity Clinical Research - Panorama City
Panorama City, California, 91402-3022
The Texas Liver Institute, Inc.
San Antonio, Texas, 78215
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
Velocity Clinical Research - Santa Ana
Santa Ana, California, 92704
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of CS0159 in the Treatment of Patients With Nonalcoholic Steatohepatitis (NASH)
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)
Read the detailed description
This will be a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PKs, and efficacy of CS0159 in the treatment of patients with NASH over 12 weeks.
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- CS0159 (Linafexor)
- 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.
CS0159 (Linafexor)Drug
Also called placebo
Oral QD
| Study group | Role | What they receive |
|---|---|---|
| 1.4mg CS0159 | Experimental | One tablet daily for 12 weeks Receives: Drug: CS0159 (Linafexor) |
| 2mg CS0159 | Experimental | One tablet daily for 12 weeks Receives: Drug: CS0159 (Linafexor) |
| PLACEBO | Placebo comparator | One tablet daily for 12 weeks Receives: Drug: CS0159 (Linafexor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-PDFF
To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12
Measured: Week 12
Adverse events
To evaluate the safety and tolerability of CS0159 in patients with NASH treated over 12 weeks
Measured: Week 12
Secondary outcomes (5)
Cmax
maximum concentration (Cmax) from baseline to Week 12
Measured: week 6, week 12
tmax
time to maximum plasma concentration (tmax) from baseline to Week 12
Measured: week 6, week 12
t1/2
half-life (t1/2) from baseline to Week 12
Measured: week 6, week 12
AUC
accumulation ratio of area under the concentration-time curve (AUC) in plasma from baseline to Week 12
Measured: week 6, week 12
Pharmacodynamics (PD)
Plasma concentrations and PD parameters of the biomarkers of FXR target engagement fibroblast growth factor 19 and 7α-hydroxy-4-cholesten-3-one (C4) from baseline to Week 12
Measured: week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start10 Feb 2023
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cascade Pharmaceuticals, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Rong Deng, Study director, Cascade Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591079
- Sponsor's protocol ID
- NASH-CS0159-002
- Status last verified
- Jul 2023
- First submitted
- 9 Oct 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of CS0159 in the Treatment of Patients With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT05591079
- Acronym / sponsor ID
- NASH-CS0159-002
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Cascade Pharmaceuticals, IncUniversity, hospital or other
- Collaborators
- Laboratory Corporation of America
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)
Detailed description
This will be a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PKs, and efficacy of CS0159 in the treatment of patients with NASH over 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.4mg CS0159 | Experimental | Drug: CS0159 (Linafexor)One tablet daily for 12 weeks |
| 2mg CS0159 | Experimental | Drug: CS0159 (Linafexor)One tablet daily for 12 weeks |
| PLACEBO | Placebo comparator | Drug: CS0159 (Linafexor)One tablet daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who meet the diagnosis of NASH.
- Evidence of metabolic syndrome, except for those patients with biopsy-proven NASH.
- Body mass index (BMI) >25 kg/m2, NOTE: for Asian-Americans BMI >23 kg/m2.
- Stable use of other antidiabetic, weight loss, or lipid-modifying medications for at least 12 weeks prior to randomization.
Key exclusion criteria (11 listed)
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
- Previous exposure to farnesoid X receptor (FXR) agonists 3 months prior to the first dosing.
- Current or within 6 months of screening use of drugs associated with steatosis, including but not limited to eg, methotrexate, amiodarone, high-dose estrogen, tamoxifen, long term systemic steroids, anabolic steroids, valproic acid.
- Prothrombin time international normalized ratio >1.3, unless due to therapeutic anticoagulation.
- Total bilirubin >upper limit of normal (ULN; except for patients with Gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count).
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 |
|---|---|---|
| CS0159 (Linafexor)Also: placeboOral QD | Drug | 1.4mg CS0159, 2mg CS0159, PLACEBO |
Primary outcome
MRI-PDFF
Time frame: Week 12
To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12
Adverse events
Time frame: Week 12
To evaluate the safety and tolerability of CS0159 in patients with NASH treated over 12 weeks
5 secondary outcomes
Cmax
Time frame: week 6, week 12
tmax
Time frame: week 6, week 12
t1/2
Time frame: week 6, week 12
AUC
Time frame: week 6, week 12
Pharmacodynamics (PD)
Time frame: week 6, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Rong Deng study director
Cascade Pharmaceuticals, Inc
17 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 CS0159 (Linafexor) in people with Nonalcoholic Steatohepatitis (NASH), run by Cascade Pharmaceuticals, Inc at 17 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 4 inclusion and 11 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MRI-PDFF (time frame: Week 12). 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?
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 21 Nov 2023.