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Amino Acid Mixture

AXA1125 for Non-alcoholic Fatty Liver Disease

Phase 2
Recruiting
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

Study Summary

This trial will study the effects of AXA1125, an amino acid mixture, on NASH patients. Subjects will take AXA1125 or a placebo twice daily for 48 weeks.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate size of subjects participating in this research endeavor?

"Confirmed. The information stored on clinicaltrials.gov reveals that this medical trial is actively seeking to enrol participants, since inception in May 2021 and last updated in September 2022. Specifically, 273 volunteers are needed at 64 sites throughout the country."

Answered by AI

How many locations are currently hosting this experiment?

"This trial is currently running at 64 clinics across the country, with sites in Katy, Hammond and Cincinnati as well as other places. It can be beneficial for participants to select a site close by so that travel requirements are reduced."

Answered by AI

Are there opportunities to join this experiment presently?

"Affirmative. Clinicaltrials.gov has the data verifying that, from its initial posting on May 7th 2021, this clinical trial is actively recruiting participants. To reach their target of 273 patients, 64 medical sites are enrolled in the study."

Answered by AI

Has AXA1125 been officially sanctioned for use by the FDA?

"Although there is evidence of AXA1125's safety, efficacy still needs to be explored. Therefore, our team has assigned it a score of 2 on the risk scale."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Excel Medical Clinical Trials, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I was told my tests revealed this problem but have had no rx.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
2021. "Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04880187.
All > Nash
~70 spots leftby Apr 2025
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