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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02913105




Registration number
NCT02913105
Ethics application status
Date submitted
13/09/2016
Date registered
23/09/2016

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH
Scientific 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)
Secondary ID [1] 0 0
CLMB763X2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Steatohepatitis NASH 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LMB763
Treatment: Drugs - Placebo

Experimental: LMB763 - Oral dose once daily for 12 weeks (84 days)

Placebo comparator: Placebo - Oral dose once daily for 12 weeks (84 days)


Treatment: Drugs: LMB763
Hard Gelatin Capsules

Treatment: Drugs: Placebo
Hard Gelatin Capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From date of First Participant First Treatment until Last Patient Last Visit (up to Day 112 (End of Study (EOS))
Primary outcome [2] 0 0
Change From Baseline in Alanine Aminotransferase (ALT) Levels
Timepoint [2] 0 0
Baseline to Day 84 (Week 12)
Secondary outcome [1] 0 0
Observed Maximum Plasma Concentration (Cmax) of LMB763
Timepoint [1] 0 0
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42
Secondary outcome [2] 0 0
Time to Reach Maximum Concentration (Tmax) of LMB763
Timepoint [2] 0 0
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42
Secondary outcome [3] 0 0
Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763
Timepoint [3] 0 0
0 to 96 hours post-dose on Days 1 and 42
Secondary outcome [4] 0 0
Accumulation Ratio (Racc) of LMB763
Timepoint [4] 0 0
Day 42
Secondary outcome [5] 0 0
Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)
Timepoint [5] 0 0
Baseline to Day 84 (Week 12)
Secondary outcome [6] 0 0
Change From Baseline in Weight
Timepoint [6] 0 0
Baseline to Days 28, 42, 56, 84 and 112 (EOS)
Secondary outcome [7] 0 0
Change From Baseline in Body Mass Index (BMI)
Timepoint [7] 0 0
Baseline to Days 28, 42, 56, 84 and 112 (EOS)
Secondary outcome [8] 0 0
Change From Baseline in Waist to Hip Ratio
Timepoint [8] 0 0
Baseline to Days 28, 42, 56, 84 and 112 (EOS)
Secondary outcome [9] 0 0
Change From to Baseline in Liver Stiffness
Timepoint [9] 0 0
Baseline to Day 84 (Week 12)
Secondary outcome [10] 0 0
Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel
Timepoint [10] 0 0
Baseline to Days 42 and 84
Secondary outcome [11] 0 0
Change From Baseline in Fibrosis Biomarker Test
Timepoint [11] 0 0
Baseline to Days 42 and 84
Secondary outcome [12] 0 0
Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)
Timepoint [12] 0 0
Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)
Secondary outcome [13] 0 0
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol
Timepoint [13] 0 0
Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)
Secondary outcome [14] 0 0
Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin
Timepoint [14] 0 0
Baseline to Day 84 (Week 12)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/09/2018
Sample size
Target
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - New Lambton
Recruitment hospital [2] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Georgia
State/province [10] 0 0
Tbilisi
Country [11] 0 0
Jordan
State/province [11] 0 0
Amman
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
New Zealand
State/province [13] 0 0
Christchurch
Country [14] 0 0
New Zealand
State/province [14] 0 0
Tauranga
Country [15] 0 0
New Zealand
State/province [15] 0 0
Wellington
Country [16] 0 0
Puerto Rico
State/province [16] 0 0
San Juan
Country [17] 0 0
Switzerland
State/province [17] 0 0
Bern
Country [18] 0 0
Switzerland
State/province [18] 0 0
Geneve 14
Country [19] 0 0
Switzerland
State/province [19] 0 0
Lugano
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Devon
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Glasgow
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Portsmouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02913105