Non Alcoholic Fatty Liver DiseasePhase 2NCT02941549

Safety And Efficacy Study Of Orally Administered Epeleuton In Patients With NAFLD

A Phase 2 study testing Epeleuton in people with Non Alcoholic Fatty Liver Disease, run by Afimmune at 16 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered Epeleuton capsules versus placebo in the treatment of adult patients with Non Alcoholic Fatty Liver Disease (NAFLD) Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non Alcoholic Fatty Liver Disease
What is being tested?: Epeleuton
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 16 sitesin 3 countries
Study dates: 20 Dec 2016to 4 Mar 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with NAFLD by the presence of hepatic steatosis on imaging or histology in the absence of any secondary causes.
Patients with an ALT ≥ 1.5 upper limit of normal (ULN) and < 5 ULN on two occasions 7 or more days apart during screening.
Patients with historical liver biopsy showing NASH and/or ≥ F1 fibrosis OR NFS ≥ -1.455 OR Fib- 4 ≥ 1.3 OR Fibroscan ≥8kPa within 3 months of screening.
Patients with a body mass index (BMI) between 25.0 and 40.0 kg/m² inclusive. Patients with a history of controlled obesity or controlled diabetes are allowed on the study.
Patients whose pre-study clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator.
Patients aged between 18 and 75 years inclusive.
Female patients and male patients with female partners of child bearing potential must use adequate contraception or have a sterilized partner for the duration of the study. Adequate contraception is defined as: systemic hormonal contraceptives; intrauterine device or barrier method of contraception in conjunction with spermicide; or agree to sexual abstinence, defined as a patient refraining from heterosexual intercourse during the entire period of risk associated with the study treatments and in line with their preferred and usual lifestyle. Hormonal contraceptives must be on a stable dose for at least one month before baseline.
Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.

Who cannot join

Patients with an unstable metabolic condition such as weight change > 5% in the 3 months prior to inclusion.
Patients with medical/surgical history of gastric bypass surgery, orthotopic liver transplant (OLT) or listed for OLT.
Patients with uncontrolled diabetes mellitus type 2, i.e. HbA1c ≥ 9% (75 mmol/mol) at the time of screening.
Patients with decompensated or severe liver disease as evidenced by one or more of the following: confirmed cirrhosis or suspicion of cirrhosis, esophageal varices, ascites, suspicion of portal hypertension, hospitalization for liver disease within 60 days of screening, bilirubin ≥ 2 x ULN, or ALT or AST ≥ 5 x ULN. Patients with Gilbert's syndrome are eligible if the conjugated bilirubin is ≤ 1.5 x ULN.
Patients with inflammatory bowel disease that is either active or requiring medical therapy.
Patients with diagnosed or suspected autoimmune diseases such as systemic lupus erythematosus and/or rheumatoid arthritis.

Show all 18Show fewer

Patients with a history of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas).
Patients with a significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis that, in the opinion of the Investigator, would preclude the patient from participating in and completing the study.
Patients requiring anti-diabetic treatment (including insulin sensitizing agents), and/or lipid lowering treatment, and who are not on a stable dose for at least 3 months prior to screening should be excluded. If patients are insulin dependent this treatment should have commenced at least 3 months prior to screening, however changes in dose are permitted.
Patients with known hypersensitivity to any ingredients of the study treatment.
Patients with a positive test for human immunodeficiency virus antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.
Patients with liver disease of other etiologies such as drug-induced, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, haemochromatosis, alpha-1 antitrypsin deficiency or Wilson's disease.
Patients with a significant history of drug/solvent abuse, in the opinion of the investigator.
Patients with a history of alcohol abuse in the opinion of the Investigator, or who currently drinks in excess of 21 units per week (males) or 14 units per week (females), whereby a unit consists of 10ml or 8mg of pure alcohol.
Patients who have used dietary supplements rich in omega-3 or omega-6 fatty acids in the 4 weeks prior to baseline.
Patients who have participated in any other clinical study with an investigational drug within 3 months before the first day of administration of study treatment.
Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception (as specified in inclusion criterion 7) during the study.
Patients, in the opinion of the Investigator, not suitable to participate in the study.

Trial locations and contacts

16 sites in 3 countries.

Country

City, postcode or hospital

16 sites in 3 countries

United Kingdom9 sites

UK Site 9
Belfast
UK Site 1
Birmingham, UK
UK Site 5
Birmingham, UK
UK Site 8
Liverpool
UK Site 6
London, UK
UK Site 7
Norwich, UK
UK Site 3
Oxford, UK
UK Site 4
Plymouth, UK
UK Site 2
Portsmouth, UK

Other trials in United Kingdom

Ukraine4 sites

Ukraine Site 3
Dnipro
Ukraine Site 1
Kharkiv
Ukraine Site 2
Kyiv
Ukraine Site 4
Kyiv

Other trials in Ukraine

Georgia3 sites

Georgia Site 1
Kutaisi
Georgia Site 2
Kutaisi
Georgia Site 3
Tbilisi

Other trials in Georgia

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase IIa Study To Assess The Safety And Efficacy Of Orally Administered Epeleuton In NAFLD Patients.

Conditions: Non Alcoholic Fatty Liver Disease
Being tested: Placebo capsules, Epeleuton
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo capsulesOther
EpeleutonDrug

Study groups in NCT02941549
Study group	Role	What they receive
Placebo	Placebo comparator	2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks Receives: Other: Placebo capsules
1000 mg Epeleuton	Experimental	1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks Receives: Drug: Epeleuton
2000 mg Epeleuton	Experimental	2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks Receives: Drug: Epeleuton

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Serum ALT (Alanine Aminotransferase) From Baseline to Week 16
Change in serum ALT from baseline to Week 16 using ANCOVA.
Measured: 16 Weeks
Change in Liver Stiffness Measurements by Transient Elastography From Baseline to Week 16
To evaluate change in liver stiffness measurements using Transient Elastography from baseline to Week 16 using FibroScan® 502 Touch model or equivalent.
Measured: 16 Weeks
Number of Treatment Emergent Adverse Events (TEAEs) in Each Treatment Group Leading to Treatment Discontinuation
Subjects with at least 1 TEAE leading to treatment discontinuation
Measured: 20 Weeks

Secondary outcomes (9)

Change in Serum ALT (Alanine Aminotransferase) From Baseline to Weeks 2, 4, 8 and 12
Change in serum ALT from baseline to weeks 2, 4, 8 and 12.
Measured: 12 Weeks
Change in AST (Aspartate Aminotransferase) From Baseline to Weeks 2, 4, 8, 12 and 16
Change in serum AST from baseline to weeks 2, 4, 8, 12 and 16.
Measured: 16 Weeks
Change in AST:ALT Ratio From Baseline to Weeks 2, 4, 8, 12 and 16
Change in AST: ALT ratio from baseline to weeks 2, 4, 8, 12 and 16.
Measured: 16 Weeks
Change in FIB-4 Index From Baseline to Week 16
Change in FIB-4 Index from baseline to week 16. This index is based on age, platelet count, ALT level, and AST level and will be assessed at Baseline (Visit 2) and week 16 (Visit 10). FIB-4 was calculated using the following formula: FIB4 = (Age (years) x AST (U/L))/(Platelet count (10^9/L) x √ALT (U/L)). A decrease in FIB-4 represents a positive outcome. A FIB-4 Index of <1.45 indicates none to moderate fibrosis and an Index of >3.25 indicates advanced fibrosis.
Measured: 16 Weeks
Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) From Baseline to Week 16
Change in NAFLD fibrosis score (NFS) from baseline to week 16. The NFS is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. NFS was calculated using the following formula: NAFLD fibrosis score = -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10^9/l) - 0.66 × albumin (g/dl). A decrease in NFS score represents a positive outcome. An NFS score of <-1.455 indicates no advanced fibrosis and a score of >0.676 indicates liver fibrosis.
Measured: 16 Weeks
Change in ELF (Enhanced Liver Fibrosis Score) From Baseline to Week 16
Change in ELF from baseline to week 16. Enhanced Liver Fibrosis score is an extracellular matrix marker set consisting of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP) and hyaluronic acid (HA). A decrease in ELF score represents a positive outcome. The ELF score was calculated for the instrument based on the following equation: ELF score = 2.494 + 0.846 In (CHA) + 0.735 In (CPIIINP) + 0.391 In (CTIMP-1). An ELF score of less than 7.7 indicates no fibrosis. An ELF score greater than or equal to 9.8 indicates severe fibrosis. An ELF score of 11.3 or greater indicates cirrhosis.
Measured: 16 Weeks
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16
Change in HOMA-IR from baseline to weeks 2,4,8,12,16. Homeostatic model assessment for insulin resistance (HOMA-IR) was assessed as a measure of insulin resistance. HOMA-IR is calculated by multiplying fasting plasma insulin by fasting plasma glucose, then dividing by the constant 405. A decrease in HOMA-IR indicates a positive outcome. HOMA-IR values of greater than 1.9 indicates early insulin resistance and levels above 2.9 indicate significant insulin resistance.
Measured: 16 Weeks
Change in Adipo-IR (Adipose Tissue Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16.
Change in Adipo-IR from baseline to weeks 2, 4, 8, 12 and 16. Adipose tissue insulin resistance (Adipo-IR) was assessed as a measure of insulin resistance. Adipo- IR is calculated by multiplying fasting non-esterified fatty acids by fasting insulin. A decrease in Adipo-IR indicates a positive outcome.
Measured: 16 Weeks
Change in Hepatic Fat Measured by CAP (Controlled Attenuation Parameter) From Baseline to Week 16.
Change in hepatic fat measured by CAP (controlled attenuation parameter) from baseline to week 16 using FibroScan® 502 Touch model or equivalent. CAP score is measured in decibels per meter (dB/m). A reduction in hepatic fat measured non-invasively by CAP indicates an improvement in hepatic steatosis. CAP scores range from 100 to 400dB/m. 0 to 237 dB/M indicates no hepatic steatosis, 238 to 260 dB/m indicates mild hepatic steatosis, 260 to 290 dB/m indicates moderate steatosis and a CAP score greater than 290 dB/m indicates severe steatosis.
Measured: 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 20164 Mar 2019

First posted21 Oct 2016 (estimated)
Study start20 Dec 2016
Primary completion2 Jan 2019
Study completion4 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02941549
Sponsor's protocol ID: DS102A-02
Other IDs: 2016-000311-33, 2016
Status last verified: Sep 2022
First submitted: 20 Oct 2016
Last updated: 12 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Climax J, Newsome PN, Hamza M, Weissbach M, Coughlan D, Sattar N, McGuire DK, Bhatt DL. Effects of Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid, on Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers. J Am Heart Assoc. 2020 Aug 18;9(16):e016334. doi: 10.1161/JAHA.119.016334. Epub 2020 Aug 11.
PubMed 32779505

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non Alcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase IIa Study To Assess The Safety And Efficacy Of Orally Administered Epeleuton In NAFLD Patients.
ClinicalTrials.gov ID: NCT02941549
Acronym / sponsor ID: DS102A-02
Conditions: Non Alcoholic Fatty Liver Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: AfimmuneIndustry (pharma, biotech, devices)
Study start: 20 Dec 2016 (actual)
Primary completion: 2 Jan 2019 (actual)
Study completion: 4 Mar 2019 (actual)
First posted: 21 Oct 2016 (estimated)
Results: Posted 21 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placebo capsules2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
1000 mg Epeleuton	Experimental	Drug: Epeleuton1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks
2000 mg Epeleuton	Experimental	Drug: Epeleuton2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients diagnosed with NAFLD by the presence of hepatic steatosis on imaging or histology in the absence of any secondary causes.
Patients with an ALT ≥ 1.5 upper limit of normal (ULN) and < 5 ULN on two occasions 7 or more days apart during screening.
Patients with historical liver biopsy showing NASH and/or ≥ F1 fibrosis OR NFS ≥ -1.455 OR Fib- 4 ≥ 1.3 OR Fibroscan ≥8kPa within 3 months of screening.
Patients with a body mass index (BMI) between 25.0 and 40.0 kg/m² inclusive. Patients with a history of controlled obesity or controlled diabetes are allowed on the study.
Patients whose pre-study clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator.

Key exclusion criteria (18 listed)

Patients with an unstable metabolic condition such as weight change > 5% in the 3 months prior to inclusion.
Patients with medical/surgical history of gastric bypass surgery, orthotopic liver transplant (OLT) or listed for OLT.
Patients with uncontrolled diabetes mellitus type 2, i.e. HbA1c ≥ 9% (75 mmol/mol) at the time of screening.
Patients with decompensated or severe liver disease as evidenced by one or more of the following: confirmed cirrhosis or suspicion of cirrhosis, esophageal varices, ascites, suspicion of portal hypertension, hospitalization for liver disease within 60 days of screening, bilirubin ≥ 2 x ULN, or ALT or AST ≥ 5 x ULN. Patients with Gilbert's syndrome are eligible if the conjugated bilirubin is ≤ 1.5 x ULN.
Patients with inflammatory bowel disease that is either active or requiring medical therapy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo capsules	Other	Placebo
Epeleuton	Drug	1000 mg Epeleuton, 2000 mg Epeleuton

Primary outcome

Change in Serum ALT (Alanine Aminotransferase) From Baseline to Week 16
Time frame: 16 Weeks
Change in serum ALT from baseline to Week 16 using ANCOVA.
Change in Liver Stiffness Measurements by Transient Elastography From Baseline to Week 16
Time frame: 16 Weeks
To evaluate change in liver stiffness measurements using Transient Elastography from baseline to Week 16 using FibroScan® 502 Touch model or equivalent.
Number of Treatment Emergent Adverse Events (TEAEs) in Each Treatment Group Leading to Treatment Discontinuation
Time frame: 20 Weeks
Subjects with at least 1 TEAE leading to treatment discontinuation

9 secondary outcomes

Change in Serum ALT (Alanine Aminotransferase) From Baseline to Weeks 2, 4, 8 and 12
Time frame: 12 Weeks
Change in AST (Aspartate Aminotransferase) From Baseline to Weeks 2, 4, 8, 12 and 16
Time frame: 16 Weeks
Change in AST:ALT Ratio From Baseline to Weeks 2, 4, 8, 12 and 16
Time frame: 16 Weeks
Change in FIB-4 Index From Baseline to Week 16
Time frame: 16 Weeks
Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) From Baseline to Week 16
Time frame: 16 Weeks
Change in ELF (Enhanced Liver Fibrosis Score) From Baseline to Week 16
Time frame: 16 Weeks
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16
Time frame: 16 Weeks
Change in Adipo-IR (Adipose Tissue Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16.
Time frame: 16 Weeks
Change in Hepatic Fat Measured by CAP (Controlled Attenuation Parameter) From Baseline to Week 16.
Time frame: 16 Weeks

Results and safety

Results posted to the registry on 21 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	31	28
1000 mg Epeleuton	32	31
2000mg Epeleuton	33	31

Primary outcome: Change in Serum ALT (Alanine Aminotransferase) From Baseline to Week 16

Time frame: 16 Weeks. Least squares mean (95% Confidence Interval). Unit: U/L

Measure	Placebo n = 30	1000 mg Epeleuton n = 32	2000 mg Epeleuton n = 31
Value	-16.3 (-44.2 to 11.7)	-6.9 (-34.5 to 20.7)	-10.1 (-36.9 to 16.8)

Placebo vs 1000 mg Epeleuton: LS Mean Difference: -6.9 (95% CI -34.5 to 20.7), p = 0.5946, ANCOVA
Placebo vs 2000 mg Epeleuton: LS Mean Difference: -10.1 (95% CI -36.9 to 16.8), p = 0.7309, ANCOVA

Population analysed: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Primary outcome: Change in Liver Stiffness Measurements by Transient Elastography From Baseline to Week 16

Time frame: 16 Weeks. Least squares mean (95% Confidence Interval). Unit: kPa

Measure	Placebo n = 30	1000 mg Epeleuton n = 32	2000 mg Epeleuton n = 31
Value	-2.226 (-3.07 to -1.38)	-1.308 (-2.11 to -0.51)	-0.727 (-1.55 to 0.100)

Placebo vs 1000 mg Epeleuton: LS Mean Difference: -1.308 (95% CI -2.11 to -0.51), p = 0.0763, ANCOVA
Placebo vs 2000 mg Epeleuton: LS Mean Difference: -0.727 (95% CI -1.554 to 0.100), p = 0.0058, ANCOVA

Population analysed: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Primary outcome: Number of Treatment Emergent Adverse Events (TEAEs) in Each Treatment Group Leading to Treatment Discontinuation

Time frame: 20 Weeks. Number. Unit: TEAEs

Measure	Placebo n = 31	1000 mg Epeleuton n = 32	2000 mg Epeleuton n = 33
Value	1	0	0

Population analysed: The Safety Analysis Set consists of all patients who took at least one administration of study treatment. Patients were analysed according to the treatment actually taken.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 20 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 31 (3.2%)	16 of 31 (51.6%)	0 of 31
1000 mg Epeleuton	0 of 32 (0%)	20 of 32 (62.5%)	0 of 32
2000 mg Epeleuton	1 of 33 (3%)	14 of 33 (42.4%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32779505Climax J, Newsome PN, Hamza M, Weissbach M, Coughlan D, Sattar N, McGuire DK, Bhatt DL. Effects of Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid, on Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers. J Am Heart Assoc. 2020 Aug 18;9(16):e016334. doi: 10.1161/JAHA.119.016334. Epub 2020 Aug 11.

Related trials for Non Alcoholic Fatty Liver Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip Newsome, MBChB, FRCPE, Ph.D principal investigator

University of Birmingham

16 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epeleuton in people with Non Alcoholic Fatty Liver Disease, run by Afimmune at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom, Ukraine, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum ALT (Alanine Aminotransferase) From Baseline to Week 16 (time frame: 16 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02941549, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.