← Back to Search

Fatty Acid Derivative

Icosabutate for Non-alcoholic Fatty Liver Disease (ICONA Trial)

Phase 2
Waitlist Available
Research Sponsored by NorthSea Therapeutics B.V.
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 52 weeks
Awards & highlights

ICONA Trial Summary

This trial is testing a new drug to see if it can help people with a fatty liver disease called NASH. NASH can lead to serious liver problems, and this drug may help to improve the condition without causing further damage to the liver.

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

ICONA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
percentage of patients with resolution of NASH, defined as disappearance of ballooning (score = 0) with lobular inflammation score 0 or 1, with no worsening of fibrosis.
Secondary outcome measures
Change from baseline in Nonalcoholic fatty liver disease (NAFLD) activity score (NAS)
Change in bilirubin mg/dL from baseline
Changes in individual histological scores for steatosis, ballooning, inflammation, and fibrosis from baseline
+1 more

ICONA Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Icosabutate 600mgExperimental Treatment1 Intervention
Icosabutate 600mg oral capsules taken once daily for 52 weeks
Group II: Icosabutate 300mgExperimental Treatment1 Intervention
Icosabutate 300mg oral capsule taken once daily for 52 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo oral capsules taken one daily for 52 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Icosabutate
2019
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

NorthSea Therapeutics B.V.Lead Sponsor
6 Previous Clinical Trials
308 Total Patients Enrolled

Frequently Asked Questions

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

Does this research project allow people who are under the age of 65 to participate?

"In order to participate in this study, patients must be between 18-75 years old. If a patient is under 18, there are 23 other trials they may be eligible for. If a patient is over 65, there are 200 other trials they may be eligible for."

Answered by AI

Are there any specific requirements for individuals who want to sign up for this research project?

"This clinical trial is admitting 280 people aged 18 to 75 who currently have nonalcoholic steatohepatitis. To be eligible, participants must also meet the following criteria:- Be a male or female aged 18 to 75 years, inclusive- Have a fibrosis score F1 to F3, inclusive (F1 capped at 30%)- Have (NAS) greater than or equal to 4, with a score of at least 1 in each component (steatosis, lobular inflammation, and ballooning)"

Answered by AI

Could you please share how many hospitals are running this clinical trial?

"Presently, this clinical trial is enrolling patients at 38 different sites. Some of these locations include Chandler, Germantown, and Dallas. To minimize travel requirements, it is best to choose a location near to you."

Answered by AI

What are the Icosabutate clinical trial results in terms of safety?

"Icosabutate's safety was given a score of 2 by our team at Power. This is because, while there is data supporting its safety, there is none yet for efficacy."

Answered by AI

How many individuals are receiving treatment as a part of this research project?

"This study is no longer recruiting patients. The trial was created on July 17th, 2019 and last updated December 17th, 2021. However, there are currently 241 clinical trials for nonalcoholic steatohepatitis and 1 trials for Icosabutate that are still recruiting patients."

Answered by AI

How often has Icosabutate been studied in previous medical trials?

"Currently, there is 1 ongoing clinical trial investigating Icosabutate. This trial is in Phase 3 and is located in Ocoee, Florida. Additionally, there are 40 other locations running trials for Icosabutate."

Answered by AI

Are patients being actively sought for participation in this trial at this time?

"This study is no longer looking for new participants. The trial was originally posted on July 17th, 2019, with the most recent edit taking place on December 17th, 2021. However, if the searcher is interested in other studies, there are currently 241 trials actively enrolling patients with nonalcoholic steatohepatitis and 1 trials for Icosabutate actively enrolling patients."

Answered by AI

Is this research project innovative or has it been done before?

"Icosabutate is being trialed in 35 cities across 2 countries with NorthSea Therapeutics B.V. sponsoring the study. The first trial completed its Phase 2 drug approval in 2019 and involved 280 participants. Since then, 18248 more trials have completed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 2b Study of Icosabutate in Fatty Liver Disease
2019. "A Phase 2b Study of Icosabutate in Fatty Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04052516.
~49 spots leftby Apr 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