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SGLT2 Inhibitor

Tropifexor for Non-alcoholic Fatty Liver Disease (ELIVATE Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks)
Awards & highlights

ELIVATE Trial Summary

This trial is testing a new combination therapy for NASH and comparing it to placebo. The trial is double-blind, meaning neither the patients nor the researchers will know who is receiving the active drug or the placebo.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

ELIVATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, follow-up (up to 62 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Histological Improvement: Number and Percentage of Participants Who Responded at Week 48 Compared With Baseline
Number and Percentage of Participants With Resolution of NASH and no Worsening of Fibrosis
Secondary outcome measures
Change From Baseline in Alanine Transaminase (ALT) Over Time
Change From Baseline in Aspartate Aminotransferase (AST) Over Time
Change From Baseline in Gamma-glutamyltransferase (GGT) Over Time
+5 more

ELIVATE Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm C: licogliflozin monotherapyExperimental Treatment1 Intervention
Licogliflozin monotherapy arm: licogliflozin 30 mg tablet (+ placebo matching tropifexor capsule), once daily orally
Group II: Arm B: tropifexor monotherapyExperimental Treatment1 Intervention
Tropifexor monotherapy arm: tropifexor 140 mcg capsule (+ placebo matching licogliflozin tablet), once daily orally
Group III: Arm A: combination therapyExperimental Treatment2 Interventions
Combination therapy arm: tropifexor 140 mcg capsule + licogliflozin 30 mg tablet, once daily orally
Group IV: Arm D: PlaceboPlacebo Group1 Intervention
Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,857 Previous Clinical Trials
4,197,567 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
917 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total subject pool for this clinical research?

"That is correct. The clinicaltrials.gov website indicates that this study, which was initially posted on November 15th 2011, is still recruiting patients. There are 47 different enrolling centres looking for a total of 380 participants."

Answered by AI

Are there any vacancies in this clinical trial for new patients?

"Presently, this study is recruiting patients according to the clinicaltrials.gov website. This trial was initially posted on November 15th, 2011 and has most recently been updated on July 7th, 2022."

Answered by AI

Is this the first study of its kind?

"Research on tropifexor began in 2011 with a trial sponsored by Novartis Pharmaceuticals. This first study, which included 380 participants, led to the drug's approval for Phase 2 testing. As of now, the only active trial for tropifexor is once again being sponsored by Novartis Pharmaceuticals."

Answered by AI

What is the clinical evidence to support Tropifexor's efficacy?

"Novartis Investigative Site first began studying Tropifexor in 2011 and, since then, 18296 clinical trials have completed. As of now, 1 trial is ongoing with several sites based out of Manhasset, New york."

Answered by AI

When will Tropifexor likely become available for public use?

"While there is some evidence suggesting Tropifexor is safe, as it is only in Phase 2 of clinical trials, the Power team could only rate it a 2."

Answered by AI

What are we hoping to learn from this clinical trial?

"The primary objective of this clinical trial is to determine if the participants have resolution of non-alcoholic steatohepatitis (NASH) without worsening of fibrosis. Secondary objectives include Change in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) over time, Whether the participant has at least two stage improvement in fibrosis without worsening of NASH, and 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."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Oklahoma
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Novartis Investigative Site
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
2019. "Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04065841.
~45 spots leftby Apr 2025
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