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

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ClinicalTrials.gov Identifier: NCT02913105
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis NASH Drug: LMB763 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 24, 2016
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019


Arm Intervention/treatment
Experimental: LMB763
Oral dose once daily for 12 weeks (84 days)
Drug: LMB763
Hard Gelatin Capsules

Placebo Comparator: Placebo
Oral dose once daily for 12 weeks (84 days)
Drug: Placebo
Hard Gelatin Capsule




Primary Outcome Measures :
  1. Adverse event profile and safety endpoints of LMB763 in patients with NASH [ Time Frame: 12 weeks ]
  2. Change in Transaminase levels [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in % of fat in the liver assessed using MRI [ Time Frame: 12 weeks ]
  2. Change from baseline in anthropometric assessments (BMI in kg/m^2) [ Time Frame: 12 weeks ]
  3. Change from baseline on non-invasive liver fibrosis markers (Enhanced Liver Fibrosis (ELF) panel) [ Time Frame: 12 weeks ]
  4. Severity of itch sensation based on a visual analog scale (VAS) rating [ Time Frame: 12 weeks ]
  5. Change from baseline on fasting lipid profile [ Time Frame: 12 weeks ]
  6. Pharmacokinetics of LMB763 in plasma: Cmax maximum plasma concentration at steady state [ Time Frame: Within 60 min prior to dosing, post dose: +/- 15 min up to 2 hrs, +/- 30 min from ≥2 hrs up to 6 hrs on Day 1 and Day 42 ]
  7. Pharmacokinetics of LMB763 in plasma: Tmax time to reach the maximum concentration after drug administration [ Time Frame: Within 60 min prior to dosing, post dose: +/- 15 min up to 2 hrs, +/- 30 min from ≥2 hrs up to 6 hrs on Day 1 and Day 42 ]
  8. Pharmacokinetics of LMB763 in plasma: AUC area under the concentration-time curve [ Time Frame: Within 60 min prior to dosing, post dose: +/- 15 min up to 2 hrs, +/- 30 min from ≥2 hrs up to 6 hrs on Day 1 and Day 42 ]
  9. Pharmacokinetics of LMB763 in plasma: Racc the accumulation ratio [ Time Frame: Within 60 min prior to dosing, post dose: +/- 15 min up to 2 hrs, +/- 30 min from ≥2 hrs up to 6 hrs on Day 1 and Day 42 ]
  10. Pharmacokinetics of LMB763 in plasma: T1/2 the effective half-life based on drug accumulation at steady state [ Time Frame: Within 60 min prior to dosing, post dose: +/- 15 min up to 2 hrs, +/- 30 min from ≥2 hrs up to 6 hrs on Day 1 and Day 42 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913105


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Sponsors and Collaborators
Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02913105     History of Changes
Other Study ID Numbers: CLMB763X2201
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Non-alcoholic Steatohepatitis
NASH
Fatty liver disease

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases