NASH - Nonalcoholic SteatohepatitisPhase 1NCT03976687

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients

A Phase 1 study testing EYP001a in people with NASH - Nonalcoholic Steatohepatitis and Healthy, run by Enyo Pharma at 1 site in Australia.

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

This is a single centre, open label, randomized, 3 treatment arms, with and without food dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Farnesoid X Receptor (FXR) agonist/modulator EYP001a in healthy volunteers and Nonalcoholic Steatohepatitis… Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: NASH - Nonalcoholic Steatohepatitis, Healthy
What is being tested?: EYP001a
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteAustralia
Study dates: 11 Jun 2019to 25 May 2020
Phase: Phase 1
Are there results?: None posted in the registry

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Have given voluntary written informed consent;
Male/female participants aged 18 years to 75 years with a Body Mass Index (BMI) ≥ 25 kg/m² and ≤ 45 kg/m² at screening.
A female participant is eligible to participate in this study if:
She is of non-childbearing potential (defined as females with a documented tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as 12 months of spontaneous amenorrhea and follicle stimulating hormone level within the laboratory's reference range for postmenopausal females). A post-menopausal female receiving hormone replacement therapy (HRT) other than hormone replacement patches who is willing to discontinue hormone therapy 28 days before study drug dosing and agrees to remain off hormone replacement therapy for the duration of the study may be eligible for study participation. A post-menopausal female using Hormone Replacement patches who is willing to discontinue the patch 48 hours before Check in on Day -1 and until the completion of her End of Study visit is eligible for study participation.
She is of childbearing potential and is non-pregnant or non-lactating and willing to use adequate contraception from screening until 3 months after the End of Study visit. Adequate contraception is defined as a progesterone only intra uterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence in accordance with the lifestyle of the participant is acceptable.
She is of childbearing potential and is non-pregnant or non-lactating and taking the combined oral contraceptive pill and willing to discontinue the combined oral contraceptive pill 7 days prior to check in on Day -1 and until the completion of her End of Study visit and use adequate contraception from the day of cessation. Adequate contraception is defined as a diaphragm or cervical cap together with a condom. Also, total abstinence in accordance with the lifestyle of the participant is acceptable.

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Have Alanine Aminotransferase (ALT) >1.5 upper limit of normal (ULN) during screening period.
Fibroscan® Vibration-Controlled Transient Elastography (VTCE) liver stiffness (liver stiffness measure (LSM) for >8.5 kPa) and steatosis (Controlled Attenuation Parameter (CAP) ≥250 decibels per meter (dB/m)).
Normal liver function at screening for alkaline phosphatase (ALP), Total Bilirubin (TBL), conjugated Bilirubin, platelets, International normalized ratio (INR).
Nota Bene: Criteria 4 and 5 do not apply to healthy volunteers.

Who cannot join

Employee of a contract research organization (CRO) participating in this study or the Sponsor.
Patients with known non-NASH chronic liver disease (alcohol, autoimmune, Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), active hepatitis C virus (HCV)).
Female with childbearing potential if no dual safe anti-contraception method can be provided.
Renal impairment (participants with an estimated glomerular filtration rate (eGFR) computed from the Modification of Diet in Renal Disease (MDRD) formula of < 60ml/min/1.73m² are excluded). Note: participants with mild renal impairment (eGFR >60 ml/min and ≤90 ml/min) are eligible.
Has clinically relevant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia.
Has any known pre-existing medical or psychiatric condition that could interfere with the participant's ability to provide informed consent or participate in study conduct, or that may confound study findings.

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Has a history of clinically significant gastrointestinal (GI) disease, especially peptic ulcerations, GI bleeding, ulcerative colitis, Crohn's disease or Inflammatory Bowel Syndrome, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the participant or impact the validity of the study results.
Has participated in any drug study within 60 days prior to the first drug administration in the current study.
Has had major surgery within 30 days prior to the first drug administration.
Concomitant use of not listed drugs after discussion with Sponsor not admitted.
Has a history of relevant drug and/or food allergies

Trial locations and contacts

1 site in 1 country.

Australia1 site

ENYO Pharma clinical site
Randwick, New South Wales

Other trials in Australia

About this study

Official title: A Phase 1b, Open-label Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FXR Agonist/Modulator EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients

Read the detailed description

In total 16 participants (4 healthy volunteers and 12 NASH patients) will be enrolled and randomly assigned to one of the 3 treatment arms:

Treatment Arm 1: Dose A once daily morning dose (n=4 NASH patients, n=4 healthy volunteers)
Treatment Arm 2: Dose B once daily morning dose (n=4 NASH patients)
Treatment Arm 3: Dose C twice daily - first morning dose and second dose 3 hours post first dose (n=4 NASH patients).

Subsequently, all the enrolled participants (both healthy volunteers and NASH patients) will be randomly assigned to one of the 2 parallel study Groups:

Group A (n=8, 2 healthy volunteers and 6 NASH patients): This group will include 2 NASH patients from Treatment Arms 1, 2 and 3 and 2 healthy volunteers from Treatment Arm 1. Participants in Group A will be dosed in a fasted state on Days 2, 3, 4 and 5 followed by dosing in fed state on Days 6, 7, 8 and 9.
Group B (n=8, 2 healthy volunteers and 6 NASH patients): This group will include 2 NASH patients from Treatment Arms 1, 2 and 3 and 2 healthy volunteers from Treatment Arm 1. Participants in Group B will be dosed in a fed state on Days 2, 3, 4 and 5 followed by dosing in fasted state on Days 6, 7, 8 and 9.

The maximum total engagement duration for eligible participants in this study is up to 76 days: 60 days screening, 1-day admission visit and 8 days dosing period (in-patient in clinical trial unit) and 7 days follow-up.

The participants who are eligible for enrolment will be admitted to the Clinical Trial Unit on Day 1. The participants will receive EYP001a at the study site by trained personnel per the schedule of dosing for the study from Day 2 to Day 9 in fed/fasted state depending upon the study group. Participants will be discharged on the morning (8:00 AM) of Day 10 after collection of last PK and PD blood samples. Participants will return to the Clinical Trial Unit on Day 16 for the follow-up visit.

Conditions: NASH - Nonalcoholic Steatohepatitis, Healthy
Being tested: EYP001a
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.

EYP001aDrug
Oral tablets

Study groups in NCT03976687
Study group	Role	What they receive
1: EYP001a Dose A	Experimental	Dose A once daily morning dose Receives: Drug: EYP001a
2: EYP001a Dose B	Experimental	Dose B once daily morning dose Receives: Drug: EYP001a
3: EYP001a Dose C	Experimental	Dose C twice daily - first dose morning dose and second dose 3 hours post first dose Receives: Drug: EYP001a

What is being measured

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

Maximum plasma concentration (Cmax) of EYP001a
Measured: Day 2 through day 9
Time to reach maximum concentration (Tmax) after EYP001a administration
Measured: Day 2 through day 9
Area under the concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-10h and AUClast) of EYP001a
Measured: Day 2 through day 9
Area under the concentration-time curve (AUC) and Maximum plasma concentration (Cmax) ratios
Measured: Day 2 through day 9
Type and frequencies of Adverse events
Measured: Day 1 through day 16

Secondary outcomes (3)

Bile acid precursor : C4 (7αhydroxy-4-cholesten-3-one)
pg/mL (picogram per milliliter). These will be measured in plasma samples using a validated method
Measured: Day 2 through day 9
Bile acid precursor : Fibroblast growth factor 19 (FGF19)
mg/mL (milligram per milliliter). These will be measured in plasma samples using a validated method
Measured: Day 2 through day 9
Total Bile acids (secondary and primary)
These will be measured in plasma samples using a validated method
Measured: Day 1 through day 9

Timeline

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

11 Jun 201925 May 2020

First posted6 Jun 2019
Study start11 Jun 2019
Primary completion25 May 2020
Study completion25 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03976687
Sponsor's protocol ID: EYP001-107
Status last verified: Sep 2020
First submitted: 4 Jun 2019
Last updated: 25 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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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A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
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Target of Suv420h1/2 in Hepatocytes
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A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
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Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
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All NASH - Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b, Open-label Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FXR Agonist/Modulator EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
ClinicalTrials.gov ID: NCT03976687
Acronym / sponsor ID: EYP001-107
Conditions: NASH - Nonalcoholic Steatohepatitis, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Enyo PharmaIndustry (pharma, biotech, devices)
Study start: 11 Jun 2019 (actual)
Primary completion: 25 May 2020 (actual)
Study completion: 25 May 2020 (actual)
First posted: 6 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

In total 16 participants (4 healthy volunteers and 12 NASH patients) will be enrolled and randomly assigned to one of the 3 treatment arms:

Treatment Arm 1: Dose A once daily morning dose (n=4 NASH patients, n=4 healthy volunteers)
Treatment Arm 2: Dose B once daily morning dose (n=4 NASH patients)
Treatment Arm 3: Dose C twice daily - first morning dose and second dose 3 hours post first dose (n=4 NASH patients).

Subsequently, all the enrolled participants (both healthy volunteers and NASH patients) will be randomly assigned to one of the 2 parallel study Groups:

Group A (n=8, 2 healthy volunteers and 6 NASH patients): This group will include 2 NASH patients from Treatment Arms 1, 2 and 3 and 2 healthy volunteers from Treatment Arm 1. Participants in Group A will be dosed in a fasted state on Days 2, 3, 4 and 5 followed by dosing in fed state on Days 6, 7, 8 and 9.
Group B (n=8, 2 healthy volunteers and 6 NASH patients): This group will include 2 NASH patients from Treatment Arms 1, 2 and 3 and 2 healthy volunteers from Treatment Arm 1. Participants in Group B will be dosed in a fed state on Days 2, 3, 4 and 5 followed by dosing in fasted state on Days 6, 7, 8 and 9.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1: EYP001a Dose A	Experimental	Drug: EYP001aDose A once daily morning dose
2: EYP001a Dose B	Experimental	Drug: EYP001aDose B once daily morning dose
3: EYP001a Dose C	Experimental	Drug: EYP001aDose C twice daily - first dose morning dose and second dose 3 hours post first dose

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Have given voluntary written informed consent;
Male/female participants aged 18 years to 75 years with a Body Mass Index (BMI) ≥ 25 kg/m² and ≤ 45 kg/m² at screening.
A female participant is eligible to participate in this study if:
Have Alanine Aminotransferase (ALT) >1.5 upper limit of normal (ULN) during screening period.
Fibroscan® Vibration-Controlled Transient Elastography (VTCE) liver stiffness (liver stiffness measure (LSM) for >8.5 kPa) and steatosis (Controlled Attenuation Parameter (CAP) ≥250 decibels per meter (dB/m)).

Key exclusion criteria (11 listed)

Employee of a contract research organization (CRO) participating in this study or the Sponsor.
Patients with known non-NASH chronic liver disease (alcohol, autoimmune, Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), active hepatitis C virus (HCV)).
Female with childbearing potential if no dual safe anti-contraception method can be provided.
Renal impairment (participants with an estimated glomerular filtration rate (eGFR) computed from the Modification of Diet in Renal Disease (MDRD) formula of < 60ml/min/1.73m² are excluded). Note: participants with mild renal impairment (eGFR >60 ml/min and ≤90 ml/min) are eligible.
Has clinically relevant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia.

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
EYP001aOral tablets	Drug	1: EYP001a Dose A, 2: EYP001a Dose B, 3: EYP001a Dose C

Primary outcome

Maximum plasma concentration (Cmax) of EYP001a
Time frame: Day 2 through day 9
Time to reach maximum concentration (Tmax) after EYP001a administration
Time frame: Day 2 through day 9
Area under the concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-10h and AUClast) of EYP001a
Time frame: Day 2 through day 9
Area under the concentration-time curve (AUC) and Maximum plasma concentration (Cmax) ratios
Time frame: Day 2 through day 9
Type and frequencies of Adverse events
Time frame: Day 1 through day 16

3 secondary outcomes

Bile acid precursor : C4 (7αhydroxy-4-cholesten-3-one)
Time frame: Day 2 through day 9
Bile acid precursor : Fibroblast growth factor 19 (FGF19)
Time frame: Day 2 through day 9
Total Bile acids (secondary and primary)
Time frame: Day 1 through day 9

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
Individual participant dataSharing planned: No

Related trials for NASH - Nonalcoholic Steatohepatitis

RecruitingPhase 3
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EYP001a in people with NASH - Nonalcoholic Steatohepatitis and Healthy, run by Enyo Pharma at 1 site in Australia.

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 10 inclusion and 11 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum plasma concentration (Cmax) of EYP001a (time frame: Day 2 through day 9). The study lists 5 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 NCT03976687.

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 25 Sep 2020.