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Tropifexor for Non-Alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Alcoholic Fatty Liver Disease (NAFLD)Tropifexor - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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1
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Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 48 weeks

48 weeks
Change in ALT and AST over time
Change in GGT over time
Change in liver fat content based on MRI - PDFF (in 40% of participants)
Occurrence of adverse events, serious adverse events, adverse events resulting in discontinuation of study treatment, adverse events of special interest and changes in vital signs and laboratory parameters
Whether the participant achieves at least one stage of improvement in fibrosis without worsening of NASH (YES/NO)
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)
Whether the participant has 5% or more reduction in body weight (YES/NO)
Whether the participant has at least one stage improvement in fibrosis (YES/NO)
Whether the participant has at least two stage improvement in fibrosis without worsening of NASH (YES/NO)
Whether the participant has resolution of NASH without worsening of fibrosis (YES/NO)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Miricorilant Dose Escalation
2
Cotadutide
2
CSG452

Trial Design

4 Treatment Groups

Arm B: tropifexor monotherapy
1 of 4
Arm C: licogliflozin monotherapy
1 of 4
Arm A: combination therapy
1 of 4
Arm D: Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

380 Total Participants · 4 Treatment Groups

Primary Treatment: Tropifexor · Has Placebo Group · Phase 2

Arm B: tropifexor monotherapy
Drug
Experimental Group · 1 Intervention: Tropifexor · Intervention Types: Drug
Arm C: licogliflozin monotherapy
Drug
Experimental Group · 1 Intervention: Licogliflozin · Intervention Types: Drug
Arm A: combination therapyExperimental Group · 2 Interventions: Tropifexor, Licogliflozin · Intervention Types: Drug, Drug
Arm D: Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,524 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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References

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