Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH
NCT ID: NCT02913105
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
122 participants
INTERVENTIONAL
2016-10-24
2018-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LMB763
Oral dose once daily for 12 weeks (84 days)
LMB763
Hard Gelatin Capsules
Placebo
Oral dose once daily for 12 weeks (84 days)
Placebo
Hard Gelatin Capsule
Interventions
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LMB763
Hard Gelatin Capsules
Placebo
Hard Gelatin Capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Culver City, California, United States
Novartis Investigative Site
Cypress, California, United States
Novartis Investigative Site
Gainesville, Florida, United States
Novartis Investigative Site
Miami Springs, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Honolulu, Hawaii, United States
Novartis Investigative Site
Baton Rouge, Louisiana, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
High Point, North Carolina, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Arlington, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Newport News, Virginia, United States
Novartis Investigative Site
New Lambton, New South Wales, Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia
Novartis Investigative Site
Tbilisi, , Georgia
Novartis Investigative Site
Amman, , Jordan
Novartis Investigative Site
Papatoetoe, Auckland, New Zealand
Novartis Investigative Site
Auckland, , New Zealand
Novartis Investigative Site
Christchurch, , New Zealand
Novartis Investigative Site
Tauranga, , New Zealand
Novartis Investigative Site
Wellington, , New Zealand
Novartis Investigative Site
San Juan, , Puerto Rico
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Geneva, , Switzerland
Novartis Investigative Site
Lugano, , Switzerland
Novartis Investigative Site
Plymouth, Devon, United Kingdom
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
Portsmouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicatrials.com
Other Identifiers
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CLMB763X2201
Identifier Type: -
Identifier Source: org_study_id
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