Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis

Completed · Phase 2

Conditions studied: Non-alcoholic Steatohepatitis (NASH)

In brief

The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

Key facts

Study ID

NCT03517540

Run by

Novartis Pharmaceuticals

People needed

193

Starts

2018-09-11

Expected to finish

2020-10-15

Last updated by the study team

2022-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent Male and female patients 18 years or older (at the time of the screening visit). Patients must weigh at least 50 kg (110 lb) and no more than 200 kg (440 lb) to participate in the study.
• Able to communicate well with the investigator, to understand and comply with the requirements of the study.
• Adequate liver biopsy sample for evaluation by Central Reader. Presence of NASH as demonstrated by histologic evidence based on liver biopsy - NASH with fibrosis stage F2/F3, demonstrated on liver biopsy during the screening period. Alternatively, a historical biopsy can be used if performed within 6 months prior to screening.

You may not qualify if…

• Use of other investigational drugs within 5 half-lives of enrollment or within 30 days whichever is longer.
• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
• Previous exposure to elafibranor, CVC, tropifexor, obeticholic acid (OCA), LMB763 or other FXR agonist.
• Participated in a clinical trial and treated with any investigational product being evaluated for the treatment of liver fibrosis or NASH in the 6 months before screening.
• Patients taking medications prohibited by the protocol. History of treated or untreated malignancy of any organ system, other than localized basal cell carcinoma of the skin or treated cervical intraepithelial neoplasia, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases .
• Pregnant or nursing (lactating) women. Women of child-bearing potential. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average) and/or a score on the modified AUDIT questionnaire ≥ 8.
• Inability to reliably quantify alcohol consumption. History or evidence of ongoing drug abuse, within the last 6 months prior to randomization.
• Prior or planned (during the study) bariatric surgery. Uncontrolled diabetes defined as HbA1c ≥ 9% at screening Clinical evidence of hepatic decompensation or severe liver impairment. Previous diagnosis of other forms of chronic liver disease. Calculated eGFR less than 60 mL/min (using the MDRD formula). History of biliary diversion History of liver transplantation or planned liver transplant. Known positivity for HIV. History or current diagnosis of ECG abnormalities indicating significant risk of safety for the patient to participate.
• History of inflammatory bowel disease. Patients who are not candidates for liver biopsy. Presence of cirrhosis on liver biopsy (F4 by NASH CRN System) or medical history Patients with an abnormal platelet count (referring to reference ranges from the central lab).

Where it is running

• Novartis Investigative Site — Rialto, California, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Marietta, Georgia, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Metairie, Louisiana, United States
• Novartis Investigative Site — Shreveport, Louisiana, United States
• Novartis Investigative Site — Concord, North Carolina, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Morehead City, North Carolina, United States
• Novartis Investigative Site — Providence, Rhode Island, United States
• Novartis Investigative Site — Chattanooga, Tennessee, United States
• Novartis Investigative Site — Germantown, Tennessee, United States
• Novartis Investigative Site — Hermitage, Tennessee, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Murray, Utah, United States
• Novartis Investigative Site — Richmond, Virginia, United States
• Novartis Investigative Site — Richmond, Virginia, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Caba, Buenos Aires, Argentina
• Novartis Investigative Site — San Juan Bautista, Buenos Aires, Argentina
• Novartis Investigative Site — Pasadena, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.