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

Recruiting at 17 trial locations

Overseen By Rong Deng

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cascade Pharmaceuticals, Inc

Must not be taking: Investigational drugs, FXR agonists

Disqualifiers: Steatosis drugs, Hypertension, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

99 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have been on stable doses of antidiabetic, weight loss, or lipid-modifying medications for at least 12 weeks before joining. However, you cannot use certain other drugs, like those associated with liver issues, within specific time frames before starting the trial.

What is the purpose of this trial?

This trial is testing a new drug called CS0159 to see if it can help people with a liver disease called NASH. The study will check if the drug is safe and if it can improve liver health by reducing inflammation and fat in the liver.

Research Team

Rong Deng

Principal Investigator

Cascade Pharmaceuticals, Inc

Eligibility Criteria

Inclusion Criteria

Body mass index (BMI) >25 kg/m2 (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 have been diagnosed with a condition called NASH.

Exclusion Criteria

You have taken medications that activate the farnesoid X receptor (FXR) within the past 3 months.

Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer

Current or within 6 months of screening use of drugs associated with steatosis, including but not limited to methotrexate, amiodarone, high-dose estrogen, tamoxifen, long term systemic steroids, anabolic steroids, valproic acid

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 2mg or 1.4mg of CS0159 or placebo daily for 12 weeks

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CS0159 (Linafexor)

Participant Groups

Group I: 2mg CS0159 Experimental Treatment 1 Intervention

One tablet daily for 12 weeks

Group II: 1.4mg CS0159 Experimental Treatment 1 Intervention

One tablet daily for 12 weeks

Group III: PLACEBO Placebo Group 1 Intervention

One tablet daily for 12 weeks

Who Is Running the Clinical Trial?

Cascade Pharmaceuticals, Inc

Lead Sponsor

Trials

9

Recruited

540+

Laboratory Corporation of America

Industry Sponsor

Trials

32

Recruited

18,800+