Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04816916

Acronym

EMMPOWER

Enrollment

Registered

2021-03-25

Start date

2021-06-29

Completion date

2022-06-30

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Keywords

liver cirrhosis, end stage liver disease, sarcopenia, amino acids

Brief summary

This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.

Interventions

DRUGAXA1665

AXA1665 administered TID with food

DRUGPlacebo

Matching placebo administered TID with food

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Willing to participate in the study and provide written informed consent. * Male and female adults aged ≥18 years. * History of cirrhosis and at least 1 prior episode of overt hepatic encephalopathy (OHE) prior to Screening. * A PHES of ≤ -4 during Screening. * MELD score of ≤ 22 at Screening. * Support of a primary caregiver who is able and willing to give written informed consent.

Exclusion criteria

* Hospitalization or serious medical condition. * Presence of Child's-Pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (SBP). * History of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement. * Expectation of a liver transplant during the study. * Use of marijuana or tetrahydrocannabinol (THC) within 1 week prior to Screening and during the study.

Design outcomes

Primary

Measure	Time frame
Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)	Baseline to week 24

Secondary

Measure	Time frame
Time to and frequency of recurrent overt hepatic encephalopathy	Baseline to week 24
Impact on physical function assessed by Liver Frailty Index (a composite measure of hand grip strength, balance and ability to stand up from a chair)	Baseline to week 24
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)	Baseline to week 24

Countries

Canada, Hungary, Italy, Poland, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026