Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

A Randomized, Double-blind, Parallel-group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Oral Tropifexor (LJN452) & Licogliflozin (LIK066) Combination Therapy and Each Monotherapy, Compared With Placebo for Treatment of Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis.(ELIVATE)

ClinicalTrials.gov Identifier: NCT04065841

Novartis Reference Number: CLJN452D12201C

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis

Condition 
Non Alcoholic Steatohepatitis (NASH)
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
380 participants
Start date 
Dec 30, 2019
Completion date 
Apr 12, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Tropifexor
Tropifexor is a highly potent, specific and orally available non-bile acid agonist of the bile acid receptor FXR.
Drug
Licogliflozin
Licogliflozin is a selective and potent inhibitor of the sodium glucose co-transporters (SGLTs) 1 and 2
Other
Placebo
licogliflozin placebo + tropifexor placebo

Eligibility Criteria

Inclusion Criteria:

Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following:

NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation and ballooning and
Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria

Exclusion Criteria:

Type 1 diabetes mellitus
Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at screening
HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas

Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:

Platelet count < LLN (see Central laboratory manual).
Serum albumin < LLN (see Central laboratory manual).
International Normalized Ratio (INR) > ULN (see Central laboratory manual).
ALT or AST > 5× ULN (confirmed by 2 values during screening).
Total bilirubin > ULN (see Central laboratory manual) (confirmed by 2 values during screening), including Gilbert's syndrome.
Alkaline phosphatase > 300 IU/L (confirmed by 2 values during screening).
History of esophageal varices, ascites or hepatic encephalopathy
Splenomegaly
MELD score >12

Study Locations

United States
Novartis Investigative Site
Recruiting
Dothan, 36305
Alabama
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90057
California
United States
Novartis Investigative Site
Recruiting
Pasadena, 91105
California
United States
Novartis Investigative Site
Recruiting
San Diego, 91942
California
United States
Novartis Investigative Site
Recruiting
San Diego, 92123
California
United States
Novartis Investigative Site
Recruiting
Van Nuys, 91405
California
United States
Novartis Investigative Site
Recruiting
Ventura, 93003
California
United States
Novartis Investigative Site
Recruiting
Doral, 33166
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33126
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33165-7574
Florida
United States
Novartis Investigative Site
Recruiting
Palm Harbor, 34684
Florida
United States
Novartis Investigative Site
Recruiting
South Miami, 33143
Florida
United States
Novartis Investigative Site
Recruiting
Marietta, 30060
Georgia
United States
Novartis Investigative Site
Recruiting
South Bend, 46635
Indiana
United States
Novartis Investigative Site
Recruiting
Bastrop, 71220
Louisiana
United States
Novartis Investigative Site
Recruiting
Chesterfield, 48047
Michigan
United States
Novartis Investigative Site
Recruiting
Wyoming, 49519
Michigan
United States
Novartis Investigative Site
Recruiting
Jackson, 39216
Mississippi
United States
Novartis Investigative Site
Recruiting
Chesterfield, 63005
Missouri
United States
Novartis Investigative Site
Recruiting
Albuquerque, 87109
New Mexico
United States
Novartis Investigative Site
Recruiting
Lenoir, 28645
North Carolina
United States
Novartis Investigative Site
Recruiting
Morehead City, 28557
North Carolina
United States
Novartis Investigative Site
Recruiting
Cincinnati, 45242
Ohio
United States
Novartis Investigative Site
Recruiting
Tulsa, 74104
Oklahoma
United States
Novartis Investigative Site
Recruiting
Bethlehem, 18017
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Greenville, 29605
South Carolina
United States
Novartis Investigative Site
Recruiting
Greenwood, 29646
South Carolina
United States
Novartis Investigative Site
Recruiting
Summerville, 29485
South Carolina
United States
Novartis Investigative Site
Recruiting
Hermitage, 37076
Tennessee
United States
Novartis Investigative Site
Recruiting
Arlington, 76012
Texas
United States
Novartis Investigative Site
Recruiting
Austin, 78731
Texas
United States
Novartis Investigative Site
Recruiting
Dallas, 75208-2312
Texas
United States
Novartis Investigative Site
Recruiting
Dallas, 75230
Texas
United States
Novartis Investigative Site
Recruiting
Plano, 75075
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78215
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78229
Texas
United States
Novartis Investigative Site
Recruiting
Sugar Land, 77479
Texas
United States
Novartis Investigative Site
Recruiting
Murray, 84107
Utah
United States
Novartis Investigative Site
Recruiting
Richmond, 23294
Virginia
United States
Belgium
Novartis Investigative Site
Recruiting
Genk, 3600
-
Belgium
Novartis Investigative Site
Recruiting
Mechelen, 2800
-
Belgium
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1413
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1784
-
Bulgaria
Canada
Novartis Investigative Site
Recruiting
Vancouver, V6Z 2K5
British Columbia
Canada
Chile
Novartis Investigative Site
Recruiting
Valdivia, 5110683
Los Rios
Chile
Novartis Investigative Site
Recruiting
Vina del Mar, 2540364
Valparaiso
Chile
Colombia
Novartis Investigative Site
Recruiting
Medellin, 050001
Antioquia
Colombia
Novartis Investigative Site
Recruiting
Rionegro, 054047
Antioquia
Colombia
Novartis Investigative Site
Recruiting
Bogota, 110001
-
Colombia
Estonia
Novartis Investigative Site
Recruiting
Tallinn, 10617
-
Estonia
Novartis Investigative Site
Recruiting
Tallinn, 11312
-
Estonia
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Gelnhausen, 63571
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
India
Novartis Investigative Site
Recruiting
New Delhi, 110070
Delhi
India
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Japan
Novartis Investigative Site
Recruiting
Takamatsu city, 760 8557
Kagawa
Japan
Novartis Investigative Site
Recruiting
Saga-city, 849-8501
Saga
Japan
Novartis Investigative Site
Recruiting
Izumo-city, 693 8501
Shimane
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 194354
-
Russian Federation
Novartis Investigative Site
Recruiting
Samara, 443063
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 199034
-
Russian Federation
Novartis Investigative Site
Recruiting
Tomsk, 634050
-
Russian Federation
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119074
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Cataluna
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28046
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Tainan, 70403
-
Taiwan
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34010
Topkapı
Turkey
United Kingdom
Novartis Investigative Site
Recruiting
Aberdeen, AB25 2ZN
-
United Kingdom
Novartis Investigative Site
Recruiting
London, SE5 9RS
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]