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

Last Update: Apr 28, 2022

See if you pre-qualify

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
Start date 
Dec 11, 2019
Completion date 
Mar 29, 2024
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
Tucson, 85745
Arizona
United States
Novartis Investigative Site
Recruiting
Coronado, 92118
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90048
California
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
Cooper City, 33024
Florida
United States
Novartis Investigative Site
Recruiting
Doral, 33166
Florida
United States
Novartis Investigative Site
Recruiting
Fort Myers, 33907
Florida
United States
Novartis Investigative Site
Recruiting
Lehigh Acres, 33936
Florida
United States
Novartis Investigative Site
Recruiting
Miami Springs, 33166
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33014-3616
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
Zephyrhills, 33542
Florida
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
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
Manhasset, 11030
New York
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
San Antonio, 78240
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
Novartis Investigative Site
Recruiting
Seattle, 98195
Washington
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1181ACH
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Florencio Varela, C1073ABA
Buenos Aires
Argentina
Belgium
Novartis Investigative Site
Recruiting
Genk, 3600
-
Belgium
Novartis Investigative Site
Recruiting
Mechelen, 2800
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Salvador, 40110-160
BA
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90035-003
RS
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 04037-002
SP
Brazil
Novartis Investigative Site
Recruiting
São Paulo, 05403-000
SP
Brazil
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1413
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1784
-
Bulgaria
Canada
Novartis Investigative Site
Recruiting
Calgary, T2N 4N1
Alberta
Canada
Novartis Investigative Site
Recruiting
Vancouver, V6Z 2K5
British Columbia
Canada
Novartis Investigative Site
Recruiting
Montreal, H4A 3J1
Quebec
Canada
Chile
Novartis Investigative Site
Recruiting
Valdivia, 5110683
Los Rios
Chile
Novartis Investigative Site
Recruiting
Santiago, 8330034
Region Metropolitana
Chile
Novartis Investigative Site
Recruiting
Santiago, 7500588
RM
Chile
Novartis Investigative Site
Recruiting
Vina del Mar, 2540364
Valparaiso
Chile
China
Novartis Investigative Site
Recruiting
Beijing, 102218
Beijing
China
Novartis Investigative Site
Recruiting
Hangzhou, 310015
Zhejiang
China
Novartis Investigative Site
Recruiting
Beijing, 100050
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200092
-
China
Colombia
Novartis Investigative Site
Recruiting
Medellin, 050001
Antioquia
Colombia
Novartis Investigative Site
Recruiting
Rionegro, 054047
Antioquia
Colombia
Novartis Investigative Site
Recruiting
Bogota, 110221
-
Colombia
Novartis Investigative Site
Recruiting
Bogota,
-
Colombia
Denmark
Novartis Investigative Site
Recruiting
Aarhus, 8000 C
-
Denmark
Estonia
Novartis Investigative Site
Recruiting
Tallinn, 10617
-
Estonia
Novartis Investigative Site
Recruiting
Tallinn, 11312
-
Estonia
Novartis Investigative Site
Recruiting
Tartu, 51014
-
Estonia
Germany
Novartis Investigative Site
Recruiting
Berlin, 10825
-
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
Novartis Investigative Site
Recruiting
Neuruppin, 16816
-
Germany
India
Novartis Investigative Site
Recruiting
New Delhi, 110070
Delhi
India
Novartis Investigative Site
Recruiting
Jaipur, 302004
Rajasthan
India
Novartis Investigative Site
Recruiting
Chandigarh, 160 012
-
India
Italy
Novartis Investigative Site
Recruiting
Milano, 20112
MI
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Novartis Investigative Site
Recruiting
Palermo, 90127
PA
Italy
Novartis Investigative Site
Recruiting
Padova, 35128
PD
Italy
Japan
Novartis Investigative Site
Recruiting
Takamatsu city, 760 8557
Kagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 236-0004
Kanagawa
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
Dongjak Gu, 07061
Seoul
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Mexico
Novartis Investigative Site
Recruiting
Cuauhtemoc, 06700
Ciudad De Mexico
Mexico
Novartis Investigative Site
Recruiting
Guadalajara, 44130
Jalisco
Mexico
Novartis Investigative Site
Recruiting
Monterrey, 64460
Nuevo Leon
Mexico
Novartis Investigative Site
Recruiting
Mexico,
-
Mexico
Puerto Rico
Novartis Investigative Site
Recruiting
San Juan, 00927
-
Puerto Rico
Russian Federation
Novartis Investigative Site
Recruiting
Novosibirsk, 630090
-
Russian Federation
Saudi Arabia
Novartis Investigative Site
Recruiting
Riyadh, 11525
SAU
Saudi Arabia
Novartis Investigative Site
Recruiting
Riyadh, 11211
-
Saudi Arabia
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119074
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, S308433
-
Singapore
Slovakia
Novartis Investigative Site
Recruiting
Kosice, 04066
Slovak Republic
Slovakia
Novartis Investigative Site
Recruiting
Martin, 036 59
-
Slovakia
South Africa
Novartis Investigative Site
Recruiting
Port Elizabeth, 6001
Eastern Cape
South Africa
Novartis Investigative Site
Recruiting
Cape Town, 7531
-
South Africa
Spain
Novartis Investigative Site
Recruiting
Santander, 39008
Cantabria
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28046
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28222
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Kaohsiung, 80756
-
Taiwan
Novartis Investigative Site
Recruiting
Tainan, 70403
-
Taiwan
Novartis Investigative Site
Recruiting
Taoyuan, 33305
-
Taiwan
Turkey
Novartis Investigative Site
Recruiting
Bursa, 16059
Gorukle
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, E1 1BB
-
United Kingdom
Novartis Investigative Site
Recruiting
London, SE5 9RS
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]