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Trial record 8 of 107 for:    alanine | Non-Alcoholic Steatohepatitis

Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients

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ClinicalTrials.gov Identifier: NCT03205150
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to assess the effects of LIK066 on a variety of metabolic and inflammation biomarkers in patients with non-alcoholic steatohepatitis (NASH)

Condition or disease Intervention/treatment Phase
Obese Patients With Non-alcoholic Steatohepatitis (NASH) Drug: LIK066 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week Randomized, Patient and Investigator Blinded, Placebo-controlled, Parallel Group Study to Investigate the Efficacy of LIK066 in Obese Patients With Non-alcoholic Steatohepatitis (NASH)
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : September 3, 2019
Estimated Study Completion Date : October 1, 2019


Arm Intervention/treatment
Experimental: LIK066 Dose 1
LIK066 Dose 1 will be taken once daily before lunch for 12 weeks
Drug: LIK066
LIK066 tablets will be taken orally once daily

Experimental: LIK066 Dose 2
LIK066 Dose 2 will be taken once daily before lunch for 12 weeks.
Drug: LIK066
LIK066 tablets will be taken orally once daily

Experimental: Placebo
Placebo will be taken once daily before lunch for 12 weeks.
Drug: Placebo
Placebo tablets will be taken orally once a day




Primary Outcome Measures :
  1. Change from baseline in Alanine aminotransferase (ALT) at week 12 [ Time Frame: Baseline, week 12 ]
    To determine the effect of LIK066 on ALT after 12 weeks of treatment


Secondary Outcome Measures :
  1. Change from baseline in Aspartate aminotransferase (AST) at week 12 [ Time Frame: Baseline, week 12 ]
    To determine the effect of LIK066 on AST after 12 weeks of treatment

  2. Change from baseline in percent liver fat at week 12 [ Time Frame: Baseline, week 12 ]
    To determine the effect of LIK066 on intrahepatic lipid after 12 weeks of treatment as measured by MRI

  3. Change from baseline in total body weight at week 12 [ Time Frame: Baseline, week 12 ]
    To determine the effect of LIK066 on total body weight after 12 weeks of treatment

  4. Change from baseline on non-invasive liver fibrosis markers (Enhanced Liver Fibrosis (ELF) panel) at week 12 [ Time Frame: baseline, week 12 ]
    To determine the effect of LIK066 on non-invasive markers of liver fibrosis after 12 weeks of treatment

  5. Pharmacokinetics of LIK066: Observed maximum time duration of maximum concentration (Tmax) following drug administration [ Time Frame: Day 56 (0, 1,2, 4 and 6 hrs post dose) ]
    To evaluate Tmax of LIK066 in NASH patients

  6. Pharmacokinetics of LIK066: Observed area under the curve up to the last measurable concentration (AUClast) following drug administration [ Time Frame: Day 56 (0, 1,2, 4 and 6 hrs post dose) ]
    To evaluate AUClast of LIK066 in NASH patients

  7. Pharmacokinetics of LIK066: Observed maximum plasma concentration (Cmax) following drug administration [ Time Frame: Day 56 (0, 1,2, 4 and 6 hrs post dose) ]
    To evaluate Cmax of LIK066 in NASH patients

  8. Change from baseline in body mass index (BMI) at week 12 [ Time Frame: Baseline, week 12 ]
    To determine the effect of LIK066 on BMI after 12 weeks of treatment

  9. Change from baseline in waist and hip (WTH) ratio at week 12 [ Time Frame: Baseline, week 12 ]
    To determine the effect of LIK066 on waist and hip (WTH) ratio after 12 weeks of treatment



Information from the National Library of Medicine

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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:

EITHER

-Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3 in the absence of a histological diagnosis of alternative chronic liver disease AND ALT greater than or equal to 50 IU/L (males) or greater than or equal to 35 IU/L (females) at screening.

OR

Phenotypic diagnosis of NASH based on presence of ALL three of the following at screening:

  • ALT greater than or equal to 50IU/L (males) or greater than or equal to 35 IU/L (females) AND
  • BMI greater than or equal to 27 kg/m^2 (in patients with a self-identified race other than Asian) or greater than or equal to 23 kg/m^2 (in patients with a self identified Asian race) AND
  • Diagnosis of Type 2 diabetes mellitus by HbA1c: greater than or equal to 6.5 % and less than or equal to 10%
  • Patients must weigh no more than 150 kg (330 lbs) to participate in the study.
  • Male and female patients 18 years or older at the time of screening visit.

Exclusion Criteria:

  • History or presence of other concomitant liver diseases
  • History or current diagnosis of ECG abnormalities
  • Use of GLP-1 agonists, SGLT2 inhibitors, TZDs, FXR agonists and any pharmacologically active weight loss drugs within 6 weeks of screening and until end of study
  • Patients with contraindications to MRI imaging
  • Current or history of significant alcohol consumption
  • Clinical evidence of hepatic decompensation or severe liver impairment
  • Women of child bearing potential (unless on basic contraception methods)
  • Presence of liver cirrhosis

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): NCT03205150


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Florida
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33126
United States, Louisiana
Novartis Investigative Site Recruiting
Baton Rouge, Louisiana, United States, 70808
Novartis Investigative Site Recruiting
New Orleans, Louisiana, United States, 70121
United States, Missouri
Novartis Investigative Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, Tennessee
Novartis Investigative Site Recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
Novartis Investigative Site Recruiting
Live Oak, Texas, United States, 78233
Argentina
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1056ABJ
Novartis Investigative Site Recruiting
Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1119ACN
Novartis Investigative Site Recruiting
Buenos Aires, Argentina, C1120AAC
Canada, Quebec
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H3P 3P1
Hong Kong
Novartis Investigative Site Withdrawn
Hong Kong Island, Hong Kong
Israel
Novartis Investigative Site Recruiting
Haifa, Israel, 343621
Novartis Investigative Site Recruiting
Ramat Gan, Israel
Novartis Investigative Site Recruiting
Tel Aviv, Israel, 64239
Netherlands
Novartis Investigative Site Recruiting
Leiden, Netherlands, 2333 CL
Russian Federation
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 117036
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 117198
Novartis Investigative Site Recruiting
St-Petersburg, Russian Federation, 194358
Taiwan
Novartis Investigative Site Recruiting
Chia-Yi, Taiwan, 60002
Novartis Investigative Site Recruiting
Tainan, Taiwan, 70421
Thailand
Novartis Investigative Site Recruiting
Bangkok, Thailand, 10330
Novartis Investigative Site Recruiting
Bangkok, Thailand, 10700
Novartis Investigative Site Recruiting
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03205150     History of Changes
Other Study ID Numbers: CLIK066X2204
2017-002046-71 ( EudraCT Number )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: February 28, 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
Obese
Type 2 diabetes mellitus
non-alcoholic fatty liver disease

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