Back to resultsEfficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis. (ELIVATE)
Primary Purpose
Non Alcoholic Steatohepatitis (NASH)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tropifexor
Licogliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non Alcoholic Steatohepatitis (NASH) focused on measuring NASH, Non alcoholic steatohepatitis, Tropifexor, LJN452, Licogliflozin, LIK066, 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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Arm A: combination therapy
Arm B: tropifexor monotherapy
Arm C: licogliflozin monotherapy
Arm D: Placebo
Arm Description
Combination therapy arm - (N=140): tropifexor 140 mcg + licogliflozin 30 mg, once daily
Tropifexor monotherapy arm - (N=80): tropifexor 140 mcg (+ placebo matching licogliflozin), once daily
Licogliflozin monotherapy arm - (N=80): licogliflozin 30 mg (+ placebo matching tropifexor), once daily
Placebo arm - (N=80): placebo matching tropifexor + placebo matching licogliflozin, once daily
Outcomes
Primary Outcome Measures
Whether the participant achieves at least one stage of improvement in fibrosis without worsening of Nonalcoholic steatohepatitis (NASH) (YES/NO)
To evaluate the efficacy of tropifexor + licogliflozin in combination therapy and each monotherapy treatment, as assessed by histologic improvement compared to placebo in participants with NASH and stage 2 or 3 fibrosis.
Whether the participant has resolution of NASH without worsening of fibrosis (YES/NO)
To evaluate the efficacy of tropifexor + licogliflozin in combination therapy and each monotherapy treatment, as assessed by histologic improvement compared to placebo in participants with NASH and stage 2 or 3 fibrosis.
Secondary Outcome Measures
Whether the participant achieves resolution of NASH and no worsening of fibrosis OR improvement in fibrosis by at least one stage without worsening of NASH (YES/NO)
To evaluate the efficacy of combination therapy and two monotherapies in NASH or fibrosis with a composite endpoint.
Whether the participant has at least one stage improvement in fibrosis (YES/NO)
To evaluate the efficacy of combination therapy and two monotherapies in fibrosis.
Whether the participant has at least two stage improvement in fibrosis without worsening of NASH (YES/NO)
To evaluate the efficacy of combination therapy and two monotherapies in fibrosis with no worsening of NASH
Whether the participant has 5% or more reduction in body weight (YES/NO)
To evaluate reduction in body weight
Change in liver fat content based on MRI - PDFF (in 40% of participants)
To evaluate change in liver fat content
Change in ALT and AST over time
To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH (ALT and AST)
ALT=alanine transaminase ASt=aspartate aminotransferase
Change in GGT over time
To evaluate the relationship of investigational treatment and gamma-glutamyl transferase (GGT), a marker of cholestasis and oxidative stress
Number of participants with adverse events
To evaluate the safety and tolerability of tropifexor (LJN452) in combination with licogliflozin (LIK066), and each monotherapy treatment, compared to placebo
Full Information
NCT ID
NCT04065841
First Posted
August 19, 2019
Last Updated
July 17, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04065841
Brief Title
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Acronym
ELIVATE
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
October 27, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Detailed Description
Study to compare tropifexor and licogliflozin in combination and each monotherapy with placebo for efficacy, safety, and tolerability in patients with NASH and fibrosis (stage 2 or 3) as per NASH CRN histological score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Steatohepatitis (NASH)
Keywords
NASH, Non alcoholic steatohepatitis, Tropifexor, LJN452, Licogliflozin, LIK066, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
235 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: combination therapy
Arm Type
Experimental
Arm Description
Combination therapy arm - (N=140): tropifexor 140 mcg + licogliflozin 30 mg, once daily
Arm Title
Arm B: tropifexor monotherapy
Arm Type
Experimental
Arm Description
Tropifexor monotherapy arm - (N=80): tropifexor 140 mcg (+ placebo matching licogliflozin), once daily
Arm Title
Arm C: licogliflozin monotherapy
Arm Type
Experimental
Arm Description
Licogliflozin monotherapy arm - (N=80): licogliflozin 30 mg (+ placebo matching tropifexor), once daily
Arm Title
Arm D: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm - (N=80): placebo matching tropifexor + placebo matching licogliflozin, once daily
Intervention Type
Drug
Intervention Name(s)
Tropifexor
Other Intervention Name(s)
LJN452
Intervention Description
Tropifexor is a highly potent, specific and orally available non-bile acid agonist of the bile acid receptor FXR.
Intervention Type
Drug
Intervention Name(s)
Licogliflozin
Other Intervention Name(s)
LIK066
Intervention Description
Licogliflozin is a selective and potent inhibitor of the sodium glucose co-transporters (SGLTs) 1 and 2
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
licogliflozin placebo + tropifexor placebo
Primary Outcome Measure Information:
Title
Whether the participant achieves at least one stage of improvement in fibrosis without worsening of Nonalcoholic steatohepatitis (NASH) (YES/NO)
Description
To evaluate the efficacy of tropifexor + licogliflozin in combination therapy and each monotherapy treatment, as assessed by histologic improvement compared to placebo in participants with NASH and stage 2 or 3 fibrosis.
Time Frame
48 weeks
Title
Whether the participant has resolution of NASH without worsening of fibrosis (YES/NO)
Description
To evaluate the efficacy of tropifexor + licogliflozin in combination therapy and each monotherapy treatment, as assessed by histologic improvement compared to placebo in participants with NASH and stage 2 or 3 fibrosis.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Whether the participant achieves resolution of NASH and no worsening of fibrosis OR improvement in fibrosis by at least one stage without worsening of NASH (YES/NO)
Description
To evaluate the efficacy of combination therapy and two monotherapies in NASH or fibrosis with a composite endpoint.
Time Frame
48 weeks
Title
Whether the participant has at least one stage improvement in fibrosis (YES/NO)
Description
To evaluate the efficacy of combination therapy and two monotherapies in fibrosis.
Time Frame
48 weeks
Title
Whether the participant has at least two stage improvement in fibrosis without worsening of NASH (YES/NO)
Description
To evaluate the efficacy of combination therapy and two monotherapies in fibrosis with no worsening of NASH
Time Frame
48 weeks
Title
Whether the participant has 5% or more reduction in body weight (YES/NO)
Description
To evaluate reduction in body weight
Time Frame
48 weeks
Title
Change in liver fat content based on MRI - PDFF (in 40% of participants)
Description
To evaluate change in liver fat content
Time Frame
48 weeks
Title
Change in ALT and AST over time
Description
To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH (ALT and AST)
ALT=alanine transaminase ASt=aspartate aminotransferase
Time Frame
48 weeks
Title
Change in GGT over time
Description
To evaluate the relationship of investigational treatment and gamma-glutamyl transferase (GGT), a marker of cholestasis and oxidative stress
Time Frame
48 weeks
Title
Number of participants with adverse events
Description
To evaluate the safety and tolerability of tropifexor (LJN452) in combination with licogliflozin (LIK066), and each monotherapy treatment, compared to placebo
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Novartis Investigative Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Novartis Investigative Site
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novartis Investigative Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Novartis Investigative Site
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Novartis Investigative Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novartis Investigative Site
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Novartis Investigative Site
City
Lehigh Acres
State/Province
Florida
ZIP/Postal Code
33936
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165-7574
Country
United States
Facility Name
Novartis Investigative Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Novartis Investigative Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Novartis Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Novartis Investigative Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Novartis Investigative Site
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
Novartis Investigative Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Novartis Investigative Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Novartis Investigative Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Novartis Investigative Site
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Novartis Investigative Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Novartis Investigative Site
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Novartis Investigative Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Novartis Investigative Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Novartis Investigative Site
City
Florencio Varela
State/Province
Buenos Aires
ZIP/Postal Code
C1073ABA
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Novartis Investigative Site
City
Salvador
State/Province
BA
ZIP/Postal Code
40110-160
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04037-002
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1413
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Novartis Investigative Site
City
Valdivia
State/Province
Los Rios
ZIP/Postal Code
5110683
Country
Chile
Facility Name
Novartis Investigative Site
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Novartis Investigative Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050001
Country
Colombia
Facility Name
Novartis Investigative Site
City
Rionegro
State/Province
Antioquia
ZIP/Postal Code
054047
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogota
ZIP/Postal Code
110131
Country
Colombia
Facility Name
Novartis Investigative Site
City
Aarhus
ZIP/Postal Code
8000 C
Country
Denmark
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20112
Country
Italy
Facility Name
Novartis Investigative Site
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Novartis Investigative Site
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Novartis Investigative Site
City
Takamatsu city
State/Province
Kagawa
ZIP/Postal Code
760 8557
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Novartis Investigative Site
City
Saga-city
State/Province
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Novartis Investigative Site
City
Izumo-city
State/Province
Shimane
ZIP/Postal Code
693 8501
Country
Japan
Facility Name
Novartis Investigative Site
City
Dongjak Gu
State/Province
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Cuauhtemoc
State/Province
Ciudad De Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Novartis Investigative Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Novartis Investigative Site
City
Mexico
ZIP/Postal Code
22381
Country
Mexico
Facility Name
Novartis Investigative Site
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Novosibirsk
ZIP/Postal Code
630090
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Samara
ZIP/Postal Code
443063
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
199226
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Novartis Investigative Site
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7531
Country
South Africa
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Istanbul
State/Province
Topkapı
ZIP/Postal Code
34010
Country
Turkey
Facility Name
Novartis Investigative Site
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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
Learn more about this trial
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
We'll reach out to this number within 24 hrs