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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 below

NASH Trial 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (day one, first day of treatment) to eot (day 92, 13 weeks of treatment) for reporting.

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 more
Other 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 more

NASH 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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~20 spots leftby Mar 2025