Clinical trial • Phase III • Gastroenterology

De-oiled enriched phospholipids from soya-beans for Metabolic dysfunction-associated steatotic liver disease (MASLD) / Metabolic dysfunction-associated steatohepatitis (MASH) | Alcoholic liver disease | Chronic hepatitis B

Phase III trial of De-oiled enriched phospholipids from soya-beans for Metabolic dysfunction-associated steatotic liver disease (MASLD) / Metabolic dysfun…

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Metabolic dysfunction-associated steatotic liver disease (MASLD) / Metabolic dysfunction-associated steatohepatitis (MASH) | Alcoholic liver disease | Chronic hepatitis B
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-05-2025
First CTIS Authorization Date
22-09-2025

Trial design

Randomised, essentiale® epl oral capsule: 300 mg capsules, 2 capsules tid (on top of soc) with placebo liquid once daily (morning); essentiale® epl liquid: 1800 mg once daily (morning) with placebo capsules (2 capsules tid) on top of soc; placebo arm: placebo liquid once daily (morning) and placebo capsule (2 capsules tid) on top of soc.-controlled Phase III trial in Germany, Bulgaria, Poland.

Randomised
Yes
Comparator
Essentiale® EPL oral capsule: 300 mg capsules, 2 capsules TID (on top of SoC) with placebo liquid once daily (morning); Essentiale® EPL liquid: 1800 mg once daily (morning) with placebo capsules (2 capsules TID) on top of SoC; Placebo arm: placebo liquid once daily (morning) and placebo capsule (2 capsules TID) on top of SoC.
Target Sample Size
466
Trial Duration For Participant
87

Eligibility

Recruits 466 Vulnerable population selected. Trial enrols adults (18–70 years). Signed informed consent is required (Signed Informed Consent Form). Specific subject information and consent materials include a 'Pregnant Partner ICF' and multiple language ICF/SIS documents (EN, DE, BG, PL) indicating tailored information for pregnant partners; pregnant or lactating women are excluded. No minors or assent processes are described..

Pregnancy Exclusion
Participants who are pregnant, lactating, or unable/unwilling to adhere to the required contraceptive measures
Vulnerable Population
Vulnerable population selected. Trial enrols adults (18–70 years). Signed informed consent is required (Signed Informed Consent Form). Specific subject information and consent materials include a 'Pregnant Partner ICF' and multiple language ICF/SIS documents (EN, DE, BG, PL) indicating tailored information for pregnant partners; pregnant or lactating women are excluded. No minors or assent processes are described.

Inclusion criteria

  • {"criterion_text":"- Adult participants (18 to 70 years, inclusive)\n- Participants with symptoms (energy loss (asthenia), feeling depressed, abdominal pain/discomfort, fatigue, sleeping disorder, appetite loss and nausea) assessed by Global Overall Symptom (GOS) score either 3 or higher at baseline visit and at least one of the following chronic liver diseases based on physician diagnosis available at the baseline visit (which can be based on existing patient medical records/history): a) Metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH) b). Alcoholic liver disease (ALD) c). Chronic Viral Hepatitis B (HBV)\n- Participants receiving standard care for the pre-existing liver disease\n- Participants are willing not to consume alcohol and undergo alcohol withdrawal programme if they have a history of alcoholism, and are willing to implement diet control and exercise programme if required\n- Signed Informed Consent Form\n- Expressed willingness to comply with all trial procedures and availability for the duration of the trial\n- Ability to take oral therapy and be willing to adhere to the different interventions of this trial\n- Woman of childbearing potential (WOCBP) must agree to use at least one highly effective contraceptive method (hormonal contraceptives, IUD/IUS, or bilateral tubal occlusion) throughout the study and for 30 days after the last dose of trial intervention. Barrier methods (e.g., condoms) are acceptable only when combined with a highly effective method.\n- Male participants with partners of childbearing potential must use condoms in addition to their partner’s use of a highly effective contraceptive method during the study and for 30 days after the last dose."}

Exclusion criteria

  • {"criterion_text":"- Hepatic cirrhosis within 3 months before the screening visit\n- Has been using Essentiale (or any similar EPL product) within 1 month before the participant enrolment visit\n- Use of OTC medicinal products and dietary supplements known to affect liver function, including milk thistle (silymarin), and other herbal or natural products with potential hepatoprotective effects, within 30 days prior to screening and throughout the study period\n- Is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or potentially is at risk of non-compliance to trial procedures.\n- Drugs and/or alcohol abuse\n- Female participant of childbearing potential (WOCBP) without a negative pregnancy test result\n- Participants who are pregnant, lactating, or unable/unwilling to adhere to the required contraceptive measures\n- Hypersensitivity to Essentiale®, the IMP, their components or any of their excipients that, in the opinion of the Investigator, contraindicates participation in the trial.\n- Severe heart disease (e.g., heart failure), according to New York Heart Association Functional Classification (Class II–IV; The Criteria Committee of the New York Heart Association 1994) or severe renal impairment, as defined by estimated glomerular filtration rate of <15 mL/min/1.73 m2\n- Other causes of liver disease or abnormal laboratory results (AST ≥4 × upper limit of normal [ULN], ALT ≥4 × ULN, bilirubin ≥2 × ULN), or cirrhosis within 3 months before the participant screening visit\n- Diagnosed with any of the following: a) Diagnosed with type 1 diabetes mellitus b) Gastroesophageal reflux disease c) Autoimmune hepatitis d) Fulminant hepatitis e) Diagnosis of cancer f) Parenteral nutrition\n- Is enrolled in another clinical trial or has taken other investigational drug(s) within 1 month before the participant enrolment visit"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Changes in overall symptoms evaluation using the GOS score","definition_or_measurement_approach":"Using the Global Overall Symptom (GOS) score (changes from baseline)"}

Secondary endpoints

  • {"endpoint_text":"- Changes in key individual symptoms using the GOS scale","definition_or_measurement_approach":"Assessed using the GOS (Global Overall Symptom) scale"}
  • {"endpoint_text":"- Change in CLDQ global score","definition_or_measurement_approach":"Measured by change in the Chronic Liver Disease Questionnaire (CLDQ) global score"}
  • {"endpoint_text":"- Incidence and severity of TEAEs","definition_or_measurement_approach":"Recording incidence and severity of treatment-emergent adverse events (TEAEs)"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
466
Recruitment Window Months
8
Consent Approach
Informed consent must be signed by the participant (Signed Informed Consent Form). Subject information and ICF materials are provided in multiple languages (English, German, Bulgarian, Polish). Specific 'Pregnant Partner ICF' and participant guides (e.g., Viedoc Me Guide) are included. Only adult participants (18–70) provide consent; no assent for minors is described.

Methods

  • Recruitment arrangements documents (K1) available (languages: EN, PL, BG) — recruitment procedures/materials submitted
  • Recruitment advertisement materials (K2) available (languages: DE, PL, BG) — advertisement materials submitted
  • Site-based recruitment via listed investigational sites (hospital/clinic sites in Germany, Bulgaria, Poland) as per trial sites listing

Geography

Total Number Of Sites
27
Total Number Of Participants
466

Germany

Earliest CTIS Part Ii Submission Date
19-08-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
125
Number Of Sites
6
Number Of Participants
76

Sites

Site Name
Ruppiner Kliniken GmbH
Department Name
Medizinische Klinik B
Principal Investigator Name
Karsten-Henrich Weylandt
Principal Investigator Email
karsten.weylandt@mhb-fontane.de
Contact Person Name
Karsten-Henrich Weylandt
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Medizinische Klinik und Poliklinik
Principal Investigator Name
Christian Labenz
Principal Investigator Email
christian.labenz@unimedizin-mainz.de
Contact Person Name
Christian Labenz
Site Name
Eugastro GmbH
Department Name
Eugastro GmbH
Principal Investigator Name
Ingolf Schiefke
Principal Investigator Email
christiane.thyrolf@eugastro.de
Contact Person Name
Ingolf Schiefke
Contact Person Email
christiane.thyrolf@eugastro.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Hepatologie / Gastroenterologie CVK - Hochschulambulanz
Principal Investigator Name
Munevver Demir
Principal Investigator Email
muenevver.demir@charite.de
Contact Person Name
Munevver Demir
Contact Person Email
muenevver.demir@charite.de
Site Name
Universitaet Leipzig
Department Name
Medicine II, Hepatologie
Principal Investigator Name
Johannes Wiegand
Principal Investigator Email
johannes.wiegand@medizin.uni-leipzig.de
Contact Person Name
Johannes Wiegand
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Joern Schattenberg
Principal Investigator Email
Joern.Schattenberg@uks.eu
Contact Person Name
Joern Schattenberg
Contact Person Email
Joern.Schattenberg@uks.eu

Bulgaria

Earliest CTIS Part Ii Submission Date
12-08-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
245
Number Of Sites
14
Number Of Participants
278

Sites

Site Name
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD
Department Name
Department of Gastroenterology
Principal Investigator Name
Nikolay Stoynov
Principal Investigator Email
nickolaystoynov@gmail.com
Contact Person Name
Nikolay Stoynov
Contact Person Email
nickolaystoynov@gmail.com
Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Department Name
Diagnostic Consultative Center XX
Principal Investigator Name
Dimitar Dimitrov
Principal Investigator Email
dr.dimitar.dimitrov.md@gmail.com
Contact Person Name
Dimitar Dimitrov
Site Name
Alexandrovska University Hospital
Department Name
Diagnostic Consultative Center Aleksandrovska EOOD
Principal Investigator Name
Diana Stefanova-Petrova
Principal Investigator Email
d.petrova.stefanova@gmail.com
Contact Person Name
Diana Stefanova-Petrova
Contact Person Email
d.petrova.stefanova@gmail.com
Site Name
Medical Center Dr. Kalchev Ltd.
Department Name
Medical Center Dr. Kalchev Ltd.
Principal Investigator Name
Zortitsa Kerezova
Principal Investigator Email
zornitsa.kerezova.md@gmail.com
Contact Person Name
Zortitsa Kerezova
Contact Person Email
zornitsa.kerezova.md@gmail.com
Site Name
University Multiprofessional Hospital For Active Treatment Kanev AD
Department Name
Department of General, Nasal - Septic, child and one-day surgery
Principal Investigator Name
Simeon Simeonov
Principal Investigator Email
simeon.simeonov.md@gmail.com
Contact Person Name
Simeon Simeonov
Contact Person Email
simeon.simeonov.md@gmail.com
Site Name
Multiprofile Hospital For Active Treatment Sveti Ivan Rilski 2003 OOD
Department Name
Internal Diseases Department
Principal Investigator Name
Vasil Bachev
Principal Investigator Email
Vas_bachev@abv.bg
Contact Person Name
Vasil Bachev
Contact Person Email
Vas_bachev@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Burgas AD
Department Name
Department of Gastroenterology
Principal Investigator Name
Velina Pramatarova
Principal Investigator Email
dr.velina.pramatarova@gmail.com
Contact Person Name
Velina Pramatarova
Site Name
Multiprofile Hospital For Active Treatment St Panteleimon Plovdiv Ltd.
Department Name
Department of Gastroenterology
Principal Investigator Name
Dimitar Terziev
Principal Investigator Email
dr.dimitar.terziev@gmail.com
Contact Person Name
Dimitar Terziev
Contact Person Email
dr.dimitar.terziev@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Clinic of Internal Disease
Principal Investigator Name
Yonko Yonchev
Principal Investigator Email
dr_yonchev@abv.bg
Contact Person Name
Yonko Yonchev
Contact Person Email
dr_yonchev@abv.bg
Site Name
MBAL Sveta Karidad EAD
Department Name
Department of Gastroenterology
Principal Investigator Name
Simon Sariyan
Principal Investigator Email
dr.s.sarian@abv.bg
Contact Person Name
Simon Sariyan
Contact Person Email
dr.s.sarian@abv.bg
Site Name
Purva Chastna Mbal EOOD Vratsa
Department Name
Internal Department
Principal Investigator Name
Dobromir Dragoychev
Principal Investigator Email
dr_dragoichev@abv.bg
Contact Person Name
Dobromir Dragoychev
Contact Person Email
dr_dragoichev@abv.bg
Site Name
MBAL Dr. Ivan Seliminski - Sliven AD
Department Name
Department for Gastroenterology
Principal Investigator Name
Tsvetan Danchev
Principal Investigator Email
cvetan33@abv.bg
Contact Person Name
Tsvetan Danchev
Contact Person Email
cvetan33@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Dr. Bratan Shukerov AD
Department Name
Department of Gastroenterology
Principal Investigator Name
Anastas Petrov
Principal Investigator Email
dr.petrov.anastas@gmail.com
Contact Person Name
Anastas Petrov
Contact Person Email
dr.petrov.anastas@gmail.com
Site Name
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Department Name
Department of Gastroenterology
Principal Investigator Name
Dimitar Pavlov
Principal Investigator Email
dr_pavlov@abv.bg
Contact Person Name
Dimitar Pavlov
Contact Person Email
dr_pavlov@abv.bg

Poland

Earliest CTIS Part Ii Submission Date
11-09-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
215
Number Of Sites
7
Number Of Participants
112

Sites

Site Name
NZOZ Terapia Optima
Department Name
Internal Medicine
Principal Investigator Name
Boguslaw Okopien
Principal Investigator Email
bokopien@gmail.com
Contact Person Name
Boguslaw Okopien
Contact Person Email
bokopien@gmail.com
Site Name
Endoskopia Sp. z o.o.
Department Name
Gastroenterology
Principal Investigator Name
Marek Horynski
Principal Investigator Email
badanie.kliniczne@wp.pl
Contact Person Name
Marek Horynski
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
ID Clinic Arkadiusz Pisula
Department Name
Hepatology Clinic
Principal Investigator Name
Ewa Janczewska
Principal Investigator Email
e.janczewska@poczta.fm
Contact Person Name
Ewa Janczewska
Contact Person Email
e.janczewska@poczta.fm
Site Name
Gismed Sp. z o.o.
Department Name
Hepatology
Principal Investigator Name
Aleksandra Szymczak
Principal Investigator Email
ola.szymczak@gmail.com
Contact Person Name
Aleksandra Szymczak
Contact Person Email
ola.szymczak@gmail.com
Site Name
Bodyclinic Sp. z o.o. sp.k.
Department Name
Hepatology
Principal Investigator Name
Jan Gietka
Principal Investigator Email
piotrgietka@gmail.com
Contact Person Name
Jan Gietka
Contact Person Email
piotrgietka@gmail.com
Site Name
Medical Network Sp. z o.o.
Department Name
Gastroenterology
Principal Investigator Name
Jaroslaw Kierkus
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@med-net.pl
Site Name
Centrum Medyczne W Lancucie Sp. z o.o.
Department Name
Kliniczny Oddział Chorób Zakaźnych z Pododdziałem Hepatologicznym
Principal Investigator Name
Robert Plesniak
Principal Investigator Email
robert.plesniak@wp.pl
Contact Person Name
Robert Plesniak
Contact Person Email
robert.plesniak@wp.pl

Sponsor

Primary sponsor

Full Name
Opella Healthcare Group S.A.S.
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Third parties

  • {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR","duties_or_roles":"['13']","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Aixial","duties_or_roles":"['1','10','11','12','14','2','3','4','5','6','9']","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
NC0304 Phosphatidylcholine
Active Substance
De-oiled enriched phospholipids from soya-beans
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus=1
Starting Dose
1800 mg once daily
Dose Levels
1800 mg daily
Frequency
Once daily (morning)
Maximum Dose
1800 mg
Investigational Product Name
Essentiale Forte, 300 mg, kapsułki
Active Substance
Phosphatidyl choline
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus=2
Starting Dose
300 mg capsule x 2 capsules TID (total 1800 mg/day)
Dose Levels
2 capsules TID (300 mg per capsule; 1800 mg/day)
Frequency
2 capsules three times daily (TID)
Maximum Dose
1800 mg
Investigational Product Name
Test Placebo (liquid stick packs for Essentiale Advance)
Modality
Other
Routes Of Administration
ORAL (liquid stick packs)
Route
ORAL
Starting Dose
Placebo liquid once daily (morning), matching test product
Dose Levels
Once daily (morning) stick pack
Frequency
Once daily (morning)
Investigational Product Name
Comparator Placebo (capsules)
Modality
Other
Routes Of Administration
ORAL (capsule)
Route
ORAL
Starting Dose
Placebo capsules 2 capsules TID (matching comparator capsule schedule)
Dose Levels
2 capsules TID
Frequency
2 capsules three times daily (TID)

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