Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH

Novartis

Status and phase: Terminated; Phase 2

Conditions: Non-alcoholic Steatohepatitis NASH

Treatments: Drug: LMB763; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02913105

CLMB763X2201

Details and patient eligibility

About

The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/female patients, 18 years or older
• Written informed consent
• Presence of NASH by histologic evidence (liver biopsy) and elevated alanine aminotransferase (ALT), OR phenotypic diagnosis of NASH based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus

Exclusion criteria

• Current use of obeticholic acid (OCA)
• New initiation GLP-1 agonists such as liraglutide, exenatide , lixisenatide, albiglutide or dulaglutide within 3 months of screening
• Pregnant or nursing (lactating) women
• Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping study medication
• Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
• Clinical evidence of hepatic decompensation or severe liver impairment
• Previous diagnosis of other forms of chronic liver disease
• Uncontrolled diabetes mellitus
• History or current diagnosis of ECG abnormalities
• Patients with contraindications to MRI imaging

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

122 participants in 2 patient groups, including a placebo group

LMB763

Experimental group

Description:

Oral dose once daily for 12 weeks (84 days)

Treatment:

Drug: LMB763

Placebo

Placebo Comparator group

Description:

Oral dose once daily for 12 weeks (84 days)

Treatment:

Drug: Placebo