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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis NASH

In brief

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

Key facts

Study ID

NCT02913105

Run by

Novartis Pharmaceuticals

People needed

122

Starts

2016-10-24

Expected to finish

2018-09-19

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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