Non Alcoholic Steatohepatitis (NASH)Phase 2ELIVATENCT04065841
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 Phase 2 study testing Tropifexor and Licogliflozin in people with Non Alcoholic Steatohepatitis (NASH), run by Novartis Pharmaceuticals at 80 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Alcoholic Steatohepatitis (NASH)
- What is being tested?
- Tropifexor and Licogliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 80 sitesin 24 countries
- Study dates
- 30 Dec 2019to 27 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 13Show fewer
- 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
Trial locations and contacts
80 sites in 24 countries.
80 sites in 24 countries
United States28 sites
Southwest Gastroenterology Associates
Albuquerque, New Mexico, 87109
Texas Clinical Research Institute
Arlington, Texas, 76012
Clinical Research Professionals Inc
Chesterfield, Missouri, 63005
Southern California Research Center
Coronado, California, 92118
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
Integrity Clinical Rsh LLC
Doral, Florida, 33166
Gut PC Digestive Health Specialist
Dothan, Alabama, 36305
Prisma Health
Greenville, South Carolina, 29605
Digestive Disease Research
Greenwood, South Carolina, 29646
Summit Medical Care
Hermitage, Tennessee, 37076
Southern Therapy and Adv Res LLC
Jackson, Mississippi, 39216
Galenus Group
Lehigh Acres, Florida, 33936
Clinical Trials Of America LLC
Lenoir, North Carolina, 28645
Velocity Clinical Trials
Los Angeles, California, 90057
Northwell Health
Manhasset, New York, 11030
Genoma Research Group Inc
Miami, Florida, 33165-7574
Diabetes And Endocrinology Conslt
Morehead City, North Carolina, 28557
California Liver Research Institute
Pasadena, California, 91105
American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215
Clinical Trials of Texas
San Antonio, Texas, 78229
Endeavor Clinical Trials
San Antonio, Texas, 78240
Medical Associates Research Group
San Diego, California, 92123
Digestive Res Alliance of Michiana
South Bend, Indiana, 46635
Pioneer Research Solutions
Sugar Land, Texas, 77479
Palmetto Clinical Research
Summerville, South Carolina, 29485
Options Health Research
Tulsa, Oklahoma, 74104
San fernando Valley Health Institute
Van Nuys, California, 91405
Island View Gastroenterology Associates
Ventura, California, 93003
Brazil4 sites
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-003
Novartis Investigative Site
Salvador, Estado de Bahia, 40110-160
Novartis Investigative Site
São Paulo, São Paulo, 04037-002
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
Germany4 sites
Novartis Investigative Site
Berlin, 10825
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Mainz, 55131
Italy4 sites
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Rozzano, MI, 20089
Japan4 sites
Novartis Investigative Site
Izumo, Shimane, 693 8501
Novartis Investigative Site
Saga, Saga-ken, 849-8501
Novartis Investigative Site
Takamatsu, Kagawa-ken, 760 8557
Novartis Investigative Site
Yokohama, Kanagawa, 236-0004
Mexico4 sites
Novartis Investigative Site
Cuauhtémoc, Mexico City, 06700
Novartis Investigative Site
Guadalajara, Jalisco, 44130
Novartis Investigative Site
México, 22381
Novartis Investigative Site
Monterrey, Nuevo León, 64460
Russia4 sites
Novartis Investigative Site
Novosibirsk, 630090
Novartis Investigative Site
Saint Petersburg, 199034
Novartis Investigative Site
Saint Petersburg, 199226
Novartis Investigative Site
Samara, 443063
Colombia3 sites
Novartis Investigative Site
Bogotá, 110131
Novartis Investigative Site
Medellín, Antioquia, 050001
Novartis Investigative Site
Rionegro, Antioquia, 054047
Spain3 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28046
Bulgaria2 sites
Novartis Investigative Site
Sofia, 1413
Novartis Investigative Site
Sofia, 1784
Chile2 sites
Novartis Investigative Site
Valdivia, Los Ríos Region, 5110683
Novartis Investigative Site
Viña del Mar, Valparaiso, 2540364
Singapore2 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 169608
South Africa2 sites
Novartis Investigative Site
Cape Town, 7531
Novartis Investigative Site
Port Elizabeth, Eastern Cape, 6001
South Korea2 sites
Novartis Investigative Site
Dongjak Gu, Seoul, 07061
Novartis Investigative Site
Seoul, 03080
Taiwan2 sites
Novartis Investigative Site
Kaohsiung City, 80756
Novartis Investigative Site
Tainan, 70403
United Kingdom2 sites
Novartis Investigative Site
Aberdeen, Grampian Region, AB25 2ZN
Novartis Investigative Site
London, SE5 9RS
Argentina1 site
Novartis Investigative Site
San Juan Bautista, Buenos Aires, C1073ABA
India1 site
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110070
Turkey (Türkiye)1 site
Novartis Investigative Site
Istanbul, Topkapi, 34010
About this study
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)
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.
Read the detailed description
The study consisted of 1) a screening period, 2) a treatment period starting from randomization on Day 0 and running to Week 48, and 3) a follow-up period of 4 weeks after the last dose of study treatment. The study duration from first dose of study medication was 52 weeks.
- Conditions
- Non Alcoholic Steatohepatitis (NASH)
- Being tested
- Tropifexor, Licogliflozin, Placebo
- Keywords
- NASH, Non alcoholic steatohepatitis, Tropifexor, LJN452, Licogliflozin, LIK066, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TropifexorDrug
Also called LJN452
100mcg+30mcg+10mcg capsules of tropifexor taken orally every day until the 140 mcg capsule of tropifexor taken orally every day is produced, then patients will switch to the single 140mcg capsule taken orally every day
LicogliflozinDrug
Also called LIK066
30mg tablet of licoglifozin taken orally every day
PlaceboOther
licogliflozin placebo + tropifexor placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm A: combination therapy | Experimental | Combination therapy arm: tropifexor 140 mcg capsule + licogliflozin 30 mg tablet, once daily orally Receives: Drug: Tropifexor; Drug: Licogliflozin |
| Arm B: tropifexor monotherapy | Experimental | Tropifexor monotherapy arm: tropifexor 140 mcg capsule (+ placebo matching licogliflozin tablet), once daily orally Receives: Drug: Tropifexor |
| Arm C: licogliflozin monotherapy | Experimental | Licogliflozin monotherapy arm: licogliflozin 30 mg tablet (+ placebo matching tropifexor capsule), once daily orally Receives: Drug: Licogliflozin |
| Arm D: Placebo | Placebo comparator | Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline
Response was defined as at least a one-stage improvement in fibrosis without worsening of nonalcoholic steatohepatitis (NASH)
Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis.
Measured: Baseline, Week 48
Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis
Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis.
Measured: 48 weeks
Secondary outcomes (8)
Number and Percentage of Participants Who Achieved Resolution of NASH and no Worsening of Fibrosis OR Improvement in Fibrosis by at Least One Stage Without Worsening of NASH
Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis.
Measured: 48 weeks
Number and Percentage of Participants With at Least One Stage Improvement in Fibrosis
Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis.
Measured: 48 weeks
Number and Percentage of Participants With at Least Two Stage Improvement in Fibrosis Without Worsening of NASH
Fibrosis staging and Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis.
Measured: 48 weeks
Number and Percentage of Participants Achieving 5% or More Reduction in Body Weight at Week 48 Compared With Baseline
Whether the participants had 5% or more reduction in body weight.
Measured: Baseline, Week 48
Change From Baseline to Week 48 in Percent Liver Fat Content Based on Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI - PDFF)
Change in liver fat content based on MRI-PDFF.
Measured: Baseline, Week 48
Change From Baseline in Alanine Transaminase (ALT) Over Time
To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH.
Measured: Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks)
Change From Baseline in Aspartate Aminotransferase (AST) Over Time
To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH.
Measured: Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks)
Change From Baseline in Gamma-glutamyltransferase (GGT) Over Time
To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH.
Measured: Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start30 Dec 2019
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Why it stopped: The sponsor made a business decision to stop development of the trial drugs. The decision to stop the trial early was not because of any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Alcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065841
- Sponsor's protocol ID
- CLJN452D12201C
- Other IDs
- 2019-002324-32, 2019
- Acronym
- ELIVATE
- Status last verified
- Jan 2025
- First submitted
- 19 Aug 2019
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04065841
- Acronym / sponsor ID
- ELIVATE / CLJN452D12201C
- Conditions
- Non Alcoholic Steatohepatitis (NASH)
- Keywords
- NASH, Non alcoholic steatohepatitis, Tropifexor, LJN452, Licogliflozin, LIK066, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor made a business decision to stop development of the trial drugs. The decision to stop the trial early was not because of any safety concerns.
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Posted 26 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The study consisted of 1) a screening period, 2) a treatment period starting from randomization on Day 0 and running to Week 48, and 3) a follow-up period of 4 weeks after the last dose of study treatment. The study duration from first dose of study medication was 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: combination therapy | Experimental | Drug: Tropifexor, Drug: LicogliflozinCombination therapy arm: tropifexor 140 mcg capsule + licogliflozin 30 mg tablet, once daily orally |
| Arm B: tropifexor monotherapy | Experimental | Drug: TropifexorTropifexor monotherapy arm: tropifexor 140 mcg capsule (+ placebo matching licogliflozin tablet), once daily orally |
| Arm C: licogliflozin monotherapy | Experimental | Drug: LicogliflozinLicogliflozin monotherapy arm: licogliflozin 30 mg tablet (+ placebo matching tropifexor capsule), once daily orally |
| Arm D: Placebo | Placebo comparator | Other: PlaceboPlacebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TropifexorAlso: LJN452100mcg+30mcg+10mcg capsules of tropifexor taken orally every day until the 140 mcg capsule of tropifexor taken orally every day is produced, then patients will switch to the single 140mcg capsule taken orally every day | Drug | Arm A: combination therapy, Arm B: tropifexor monotherapy |
| LicogliflozinAlso: LIK06630mg tablet of licoglifozin taken orally every day | Drug | Arm A: combination therapy, Arm C: licogliflozin monotherapy |
| Placebolicogliflozin placebo + tropifexor placebo | Other | Arm D: Placebo |
Primary outcome
Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline
Time frame: Baseline, Week 48
Response was defined as at least a one-stage improvement in fibrosis without worsening of nonalcoholic steatohepatitis (NASH) Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis.
Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis
Time frame: 48 weeks
Fibrosis staging and Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) based on steatosis, lobular inflammation, and hepatocyte ballooning assessment were determined by a Study Central Reader. NASH CRN fibrosis criteria: Stage 0 = no fibrosis; Stage 1 = centrilobular pericellular fibrosis (or periportal fibrosis in children); Stage 2 = centrilobular and periportal fibrosis; Stage 3 = bridging fibrosis; and Stage 4 = cirrhosis.
8 secondary outcomes
Number and Percentage of Participants Who Achieved Resolution of NASH and no Worsening of Fibrosis OR Improvement in Fibrosis by at Least One Stage Without Worsening of NASH
Time frame: 48 weeks
Number and Percentage of Participants With at Least One Stage Improvement in Fibrosis
Time frame: 48 weeks
Number and Percentage of Participants With at Least Two Stage Improvement in Fibrosis Without Worsening of NASH
Time frame: 48 weeks
Number and Percentage of Participants Achieving 5% or More Reduction in Body Weight at Week 48 Compared With Baseline
Time frame: Baseline, Week 48
Change From Baseline to Week 48 in Percent Liver Fat Content Based on Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI - PDFF)
Time frame: Baseline, Week 48
Change From Baseline in Alanine Transaminase (ALT) Over Time
Time frame: Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks)
Change From Baseline in Aspartate Aminotransferase (AST) Over Time
Time frame: Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks)
Change From Baseline in Gamma-glutamyltransferase (GGT) Over Time
Time frame: Baseline to Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
80 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tropifexor and Licogliflozin in people with Non Alcoholic Steatohepatitis (NASH), run by Novartis Pharmaceuticals at 80 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Brazil, Germany, Italy, Japan and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline (time frame: Baseline, Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.