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SGLT2 Inhibitor

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

Summary

This trial tests two drugs, tropifexor and licogliflozin, both together and separately, to treat adults with a liver condition called NASH. Tropifexor helps reduce liver inflammation and fat buildup, while licogliflozin helps control blood sugar and also reduces liver fat. Tropifexor has shown promise in reducing liver inflammation in preliminary studies, while licogliflozin has demonstrated a significant improvement in liver health in patients with NASH. The goal is to find out if these treatments are safe and effective for people with NASH.

Eligible Conditions
  • Fatty Liver Disease

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

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

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,651 Total Patients Enrolled
~40 spots leftby Dec 2025
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