Norursodeoxycholic Acid vs. Placebo in NASH

Dr. Falk Pharma

Status and phase: Enrolling; Phase 2

Conditions: Nonalcoholic Steatohepatitis

Treatments: Drug: norUrsodeoxycholic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05083390

NUT-3/NAS

Details and patient eligibility

About

This is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase IIb trial. The trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d or 1000 mg/d norUDCA tablets vs. placebo tablets for the treatment of NASH.

Enrollment: 363 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be willing to participate in the study and provide written informed consent
• Male or female patients ≥ 18 and < 75 years
• Centrally assessed histological evidence of NASH and liver fibrosis
• Women of childbearing potential agree to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment

Exclusion criteria

• Patients taking prohibited medications
• Presence of liver cirrhosis
• Type 1 diabetes or uncontrolled Type 2 diabetes
• History or presence of any other significant concomitant liver diseases
• History of liver transplantation
• BMI >45 kg/m^2
• Any known relevant infectious disease (e.g., active tuberculosis, acquired immunodeficiency syndrome [AIDS]-defining diseases)
• Abnormal renal function (glomerular filtration rate estimated from cystatin C < 30 ml/min) at screening visit
• Any active malignant disease (except for basal cell carcinoma)
• Existing or intended pregnancy or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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363 participants in 3 patient groups, including a placebo group

norUrsodeoxycholic acid 1500 mg/day

Experimental group

Description:

3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg

Treatment:

Drug: norUrsodeoxycholic acid

norUrsodeoxycholic acid 1000 mg/day

Experimental group

Description:

3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1000 mg

Treatment:

Drug: norUrsodeoxycholic acid

Placebo to norUrsodeoxycholic acid

Placebo Comparator group

Description:

3 film-coated tablets once daily for 72 weeks containing placebo to norUrsodeoxycholic acid

Treatment:

Drug: norUrsodeoxycholic acid