Essentiale® liquid once-daily Phase III study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Opella Healthcare Group S.A.S.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

3 Mar 2026 → ongoing

Decision date (initial)

2025-09-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-521678-32-00

WHO UTN

U1111-1316-3502

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

Demonstrate clinical non-inferiority of Essentiale® EPL liquid 1800 mg on top of SoC compared to Essentiale® EPL oral capsule on top of SoC

Secondary objectives 3

1. Evaluate key individual symptoms in participants receiving Essentiale® EPL liquid 1800 mg compared to those receiving Essentiale® EPL oral capsule or placebo, all administered on top of SoC
2. Evaluate QoL in participants receiving Essentiale® EPL liquid 1800 mg compared to those receiving Essentiale® EPL oral capsule or placebo, all administered on top of SoC
3. Assess the safety of Essentiale® EPL liquid 1800 mg compared to Essentiale® EPL oral capsule and to placebo, all administered on top of SoC

Conditions and MedDRA coding

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) / MASH, Metabolic Dysfunction-Associated Steatohepatitis

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Plan to share IPD

Yes

IPD plan description

Opella endorses the PhRMA-EFPIA Principles for the Responsible Clinical Data Sharing 1. In sharing such data, Sanofi will do everything we can to protect participants’ privacy and maintain the confidentiality of their data. We will not share data when there remains a high risk that a study participant may be identified despite any efforts we have made to make the data anonymous. Any sharing data must be consistent with the participant’s informed consent and any legal or regulatory constraints or requirements. Opella accepts requests for individual participant data from Opella sponsored clinical studies through a publicly available web-based portal. https://www.clinicalstudydatarequest.com/Default.aspx

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Adult participants (18 to 70 years, inclusive)
2. 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)
3. Participants receiving standard care for the pre-existing liver disease
4. 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
5. Signed Informed Consent Form
6. Expressed willingness to comply with all trial procedures and availability for the duration of the trial
7. Ability to take oral therapy and be willing to adhere to the different interventions of this trial
8. 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.
9. 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 12

1. Hepatic cirrhosis within 3 months before the screening visit
2. Drugs and/or alcohol abuse
3. Female participant of childbearing potential (WOCBP) without a negative pregnancy test result
4. Participants who are pregnant, lactating, or unable/unwilling to adhere to the required contraceptive measures
5. Hypersensitivity to Essentiale®, the IMP, their components or any of their excipients that, in the opinion of the Investigator, contraindicates participation in the trial.
6. 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
7. 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
8. 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
9. Is enrolled in another clinical trial or has taken other investigational drug(s) within 1 month before the participant enrolment visit
10. Has been using Essentiale (or any similar EPL product) within 1 month before the participant enrolment visit
11. 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
12. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Changes in overall symptoms evaluation using the GOS score

Secondary endpoints 3

1. Changes in key individual symptoms using the GOS scale
2. Change in CLDQ global score
3. Incidence and severity of TEAEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Opella Healthcare Group S.A.S.

Sponsor organisation

Opella Healthcare Group S.A.S.

Address

157 Avenue Charles De Gaulle

City

Neuilly Sur Seine

Postcode

92200

Country

France

Scientific contact point

Organisation

Opella Healthcare Group S.A.S.

Contact name

Science Hub

Public contact point

Organisation

Opella Healthcare Group S.A.S.

Contact name

Science Hub

Third parties 2

Locations

3 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 84 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications