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Monoclonal Antibodies
Leronlimab 700 mg for Non-alcoholic Fatty Liver Disease (NASH Trial)
Phase 2
Waitlist Available
Research Sponsored by CytoDyn, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Platelet count ≥ 150,000/mm3
Criteria 1: Histologically-confirmed diagnosis of NASH on a liver biopsy, or Criteria 2: FibroScan or equivalent US test during screening (or within 6 months before screening) shows FAST (FibroScan-AST) score >0.67 and CAP ≥260.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (day one, first day of treatment) to eot (day 92, 13 weeks of treatment)
Awards & highlights
NASH Trial Summary
This study is evaluating whether a drug may help treat nonalcoholic steatohepatitis.
Eligible Conditions
- Non-alcoholic Fatty Liver Disease
NASH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNASH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline (day one, first day of treatment) to eot (day 92, 13 weeks of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (day one, first day of treatment) to eot (day 92, 13 weeks of treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MRI-PDFF Change From Baseline to Week 14
Secondary outcome measures
Alanine Aminotraferase (ALT)
Alkaline Phosphatase
Aspartate Aminotransferase (AST)
+17 moreOther outcome measures
Change from baseline in Alanine transaminase (ALT) at week 14
Change from baseline in Aspartate transaminase (AST) at week 14
Change from baseline in Low Density Lipoprotein (LDL) at week 14
+2 moreNASH Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Leronlimab 700 mgExperimental Treatment1 Intervention
Leronlimab 700 mg SC weekly injection
Group II: Leronlimab 350 mgExperimental Treatment1 Intervention
Leronlimab 350 mg SC weekly injection
Group III: PlaceboPlacebo Group1 Intervention
Placebo SC weekly injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
leronlimab 700 mg
2020
Completed Phase 2
~90
leronlimab 350 mg
2020
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
CytoDyn, Inc.Lead Sponsor
23 Previous Clinical Trials
2,471 Total Patients Enrolled
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,595 Total Patients Enrolled
Frequently Asked Questions
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