Clinical trial NCT02913105: Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH
Official title: A Randomized, Patient and Investigator Blinded, Placebo Controlled, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With Non-alcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-alcoholic Steatohepatitis NASH
Keywords: Non-alcoholic Steatohepatitis
NASH
Fatty liver disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-09-23
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From date of First Participant First Treatment until Last Patient Last Visit (up to Day 112 (End of Study (EOS))
measure: Change From Baseline in Alanine Aminotransferase (ALT) Levels
timeFrame: Baseline to Day 84 (Week 12)
Secondary outcomes:
measure: Observed Maximum Plasma Concentration (Cmax) of LMB763
timeFrame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42
measure: Time to Reach Maximum Concentration (Tmax) of LMB763
timeFrame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42
measure: Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763
timeFrame: 0 to 96 hours post-dose on Days 1 and 42
measure: Accumulation Ratio (Racc) of LMB763
timeFrame: Day 42
measure: Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)
timeFrame: Baseline to Day 84 (Week 12)
measure: Change From Baseline in Weight
timeFrame: Baseline to Days 28, 42, 56, 84 and 112 (EOS)
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline to Days 28, 42, 56, 84 and 112 (EOS)
measure: Change From Baseline in Waist to Hip Ratio
timeFrame: Baseline to Days 28, 42, 56, 84 and 112 (EOS)
measure: Change From to Baseline in Liver Stiffness
timeFrame: Baseline to Day 84 (Week 12)
measure: Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel
timeFrame: Baseline to Days 42 and 84
measure: Change From Baseline in Fibrosis Biomarker Test
timeFrame: Baseline to Days 42 and 84
measure: Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)
timeFrame: Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)
measure: Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol
timeFrame: Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)
measure: Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin
timeFrame: Baseline to Day 84 (Week 12)
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Novartis Investigative Site
state: California
city: Cypress
country: United States
facility: Novartis Investigative Site
state: California
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami Springs
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Honolulu
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Baton Rouge
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: High Point
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: New Lambton
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Tbilisi
country: Georgia
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Papatoetoe
country: New Zealand
facility: Novartis Investigative Site
state: Auckland
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Christchurch
country: New Zealand
facility: Novartis Investigative Site
city: Tauranga
country: New Zealand
facility: Novartis Investigative Site
city: Wellington
country: New Zealand
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Geneve 14
country: Switzerland
facility: Novartis Investigative Site
city: Lugano
country: Switzerland
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
state: Devon
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
References: