← Back to Search

Amino Acid Mixture

Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

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

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
  • Fatty Liver Disease

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement in steatohepatitis
Secondary study objectives
Improvement of fibrosis by one stage without worsening of NASH
Fibrosis

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
Stephen Harrison, MDPrincipal InvestigatorPinnacle Clinical Research
8 Previous Clinical Trials
1,458 Total Patients Enrolled

Media Library

AXA1125 (Amino Acid Mixture) Clinical Trial Eligibility Overview. Trial Name: NCT04880187 — Phase 2
Fatty Liver Disease Research Study Groups: AXA1125 33.9g, AXA1125 22.6g, Placebo
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
Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04880187 — Phase 2
~60 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top