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Amino Acid Mixture

AXA1125 for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Led By Stephen Harrison, MD
Research Sponsored by Axcella Health, Inc
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 week 48
Awards & highlights

Summary

This trial tests AXA1125, a mix of amino acids taken orally, to see if it can reduce liver fat, inflammation, and scarring in people with non-alcoholic steatohepatitis (NASH). Participants will take the treatment for several months, with liver biopsies at the start and end to measure changes. AXA1125 demonstrated multitargeted activity on relevant NAFLD pathways in a previous study.

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in steatohepatitis
Secondary outcome measures
Change from baseline in hepatic fat as measured by MRI
Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)
Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: AXA1125 33.9gExperimental Treatment1 Intervention
33.9 g AXA1125 administered orally BID with or without food
Group II: AXA1125 22.6gExperimental Treatment1 Intervention
22.6 g AXA1125 administered orally BID with or without food
Group III: PlaceboPlacebo Group1 Intervention
Matching Placebo administered orally BID with or without food
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXA1125
2018
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Axcella Health, IncLead Sponsor
7 Previous Clinical Trials
263 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
112 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Stephen Harrison, MDPrincipal InvestigatorPinnacle Clinical Research
8 Previous Clinical Trials
1,674 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
1,000 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

AXA1125 (Amino Acid Mixture) Clinical Trial Eligibility Overview. Trial Name: NCT04880187 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: AXA1125 33.9g, AXA1125 22.6g, Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: AXA1125 Highlights & Side Effects. Trial Name: NCT04880187 — Phase 2
AXA1125 (Amino Acid Mixture) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04880187 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04880187 — Phase 2
~63 spots leftby Sep 2025
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