A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH

NCT05591079 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: NASH-CS0159-002
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 17

Brief Summary

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)

Conditions

Nonalcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (2)

• MRI-PDFF

  To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12

  Week 12

• Adverse events

  To evaluate the safety and tolerability of CS0159 in patients with NASH treated over 12 weeks

  Week 12

Secondary Outcomes (5)

• Cmax

  week 6, week 12

• tmax

  week 6, week 12

• t1/2

  week 6, week 12

• AUC

  week 6, week 12

• Pharmacodynamics (PD)

  week 6, week 12

Study Arms (3)

1.4mg CS0159

EXPERIMENTAL

One tablet daily for 12 weeks

Drug: CS0159 (Linafexor)

2mg CS0159

EXPERIMENTAL

One tablet daily for 12 weeks

Drug: CS0159 (Linafexor)

PLACEBO

PLACEBO COMPARATOR

One tablet daily for 12 weeks

Drug: CS0159 (Linafexor)

Interventions

CS0159 (Linafexor) DRUG

Oral QD

Also known as: placebo

1.4mg CS0159; 2mg CS0159; PLACEBO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Cascade Pharmaceuticals, Inc: lead
• Laboratory Corporation of America: collaborator

Study Sites (17)

National Research Institute - Gardena

Gardena, California, 90247-3586, United States

Location

Velocity Clinical Research, Huntington Park

Huntington Park, California, 90255-2959, United States

Location

Velocity Clinical Research - Panorama City

Panorama City, California, 91402-3022, United States

Location

Velocity Clinical Research - Santa Ana

Santa Ana, California, 92704, United States

Location

Ocala GI Research

Lady Lake, Florida, 32159, United States

Location

Florida Research Institute

Lakewood, Florida, 34211-4930, United States

Location

San Marcus Research Clinic, Inc - Miami

Miami, Florida, 33014-5602, United States

Location

Floridian Clinical Research, LLC - Miami Lakes

Miami Lakes, Florida, 33016-1518, United States

Location

Gastroenterology Associates of Ocala

Ocala, Florida, 34471, United States

Location

Oracle Clinical Research

College Park, Georgia, 30349, United States

Location

Metropolitan Gastroenterology Associates - Westbank Office and Endoscopy

Marrero, Louisiana, 70072, United States

Location

Raja M. Din MD, PLLC - Gastroenterology & Hepatology

Greenbelt, Maryland, 20770-6702, United States

Location

Lucas Research

Morehead City, North Carolina, 28557, United States

Location

Texas Liver Institute (TLI) - Austin

Austin, Texas, 78757-7571, United States

Location

Pioneer Research Solutions Inc - Houston - Stancliff Rd

Houston, Texas, 77099-4307, United States

Location

The Texas Liver Institute, Inc.

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Rong Deng

  Cascade Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 24, 2022
• Study Start: February 10, 2023
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)