CirrhosisPhase 2Hyper-MetNCT06687265
Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension
A Phase 2 study testing Metformin in people with Cirrhosis and Portal Hypertension Related to Cirrhosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Portal hypertension (PHT) is defined by an elevated pressure gradient between the portal vein and the hepatic veins ≥ 5 mm Hg, and is the main vector of complications in cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Portal Hypertension Related to Cirrhosis
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2025to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age ≥ 18 years
- Written informed consent to participate in the study
- Medical insurance coverage
- For child-bearing aged women, contraception using oestroprogestative, progestative, intrauterine device, or mechanical contraception
- Diagnosis of cirrhosis based on a liver biopsy, or on clinical, biological, endoscopic, and radiological evidence
- Active cause of cirrhosis, or resolution (alcohol cessation, sustained virological response to direct-acting antiviral treatment for HCV, initiation of nucleoside/nucleotide analog treatment for HBV) for at least 6 months
Show all 26Show fewer
- Child-Pugh A or B
- High likelihood of HVPG ≥ 12 mm Hg based on investigator's judgement, or on the following criteria:
- Investigator's judgement
- active cause of cirrhosis and:
- History of clinical ascites
- Or history of variceal bleeding
- Or liver stiffness by VCTE ≥ 35 kPa on carvedilol in the last two years
- or spleen stiffness by VCTE ≥ 55 kPa on carvedilol in the last two years
- or liver surface nodularity ≥ 2,9 in the last two years
- or HVPG \> 16 mm Hg prior to starting NSBB
- or Laennec 4c cirrhosis on histology
- or resolution of the cause of cirrhosis for at least 6 months and:
- history of clinical ascites in the last 6 months
- or history of variceal bleeding in the last 6 months
- or liver stiffness by VCTE ≥ 35 kPa on carvedilol in the last 6 months
- or spleen stiffness by VCTE ≥ 55 kPa on carvedilol in the last 6 months
- or liver surface nodularity ≥ 2,9 in the last 12 months
- or Laennec 4c cirrhosis on histology in the last 12 months
- Treatment with carvedilol (≥ 6,25 mg/day) at a stable dose for at least one month
- Absence of hepatocellular carcinoma outside at least one nodule \> 3 cm in diameter, or more than 3 nodules, on ultrasound, CT-scan or MRI performed during the previous 6 months
Who cannot join
- Serum total bilirubin > 50 µmol/L
- Prothrombin ratio < 50 %
- Transaminases > 5 ULN
- Need for at least one paracentesis for ascites fluid evacuation in the last 6 months
- Expected follow-up < 3 months
- Known hypersensitivity to the active substance or any of the excipients
Show all 26Show fewer
- History of lactic acidosis, diabetic acidocetosis, or diabetic precoma
- Ongoing condition that may lead to acute kidney injury or hypoxia: dehydration, severe infection, shock, cardiac decompensation, respiratory failure, or myocardial infarction within the past month
- Known hypersensitivity to all the iodin-containing contrast agents
- Known hypersensitivity to lidocaine for local anesthesia
- Known hypersensitivity to beta-lactam antibiotics if the patient has a history of valve replacement
- Alcohol consumption > 14 units/week for women or > 21 units/week for men, current or abstinent for less than 6 months
- Biliary cirrhosis
- Hepatocellular carcinoma with at least one nodule > 3 cm in diameter, or more than 3 nodules
- Cholangiocarcinoma
- Extra-hepatic cancer without remission
- Severe chronic kidney disease defined as estimated glomerular filtration rate < 30 mL/min/1,73m2 using the MDRD-6 formula
- Ongoing treatment with metformin, or discontinued for less than 3 months
- Treatment with statins started or discontinued for less than 3 months
- Treatment with nucleoside/nucleotide analogue for HBV, or direct-acting antiviral treatment for HCV, started for less than 6 months
- Complete portal vein thrombosis (main portal trunk, or right branch), or portal cavernoma
- History of TIPS (transjugular intrahepatic portosystemic shunt) / surgical portosystemic derivation / liver transplantation / major hepatectomy
- Ongoing participation in another interventional therapeutic trial
- Pregnant or breastfeeding women
- Patients unable to give consent (under guardianship or curatorship)
- Non-randomisation criteria: HVPG < 12 mm Hg at the catheterism performed during the first follow-up visit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Facility Name: Beaujon hospital
Clichy, France, 92110
Lucile MOGA, Dre, 00331-71-11-46-69, lucile.moga@aphp.fr
Pierre Emmanuel Rautou, Pr, 00331-71-11-46-69, pierre-emmanuel.rautou@aphp.fr
About this study
Official title: Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension - A Randomized Placebo-controlled Study
Portal hypertension (PHT) is defined by an elevated pressure gradient between the portal vein and the hepatic veins ≥ 5 mm Hg, and is the main vector of complications in cirrhosis.
When the hepatic venous pressure gradient (HVPG) is ≥ 10 mm Hg, it is considered as a " clinically significant PHT ": ascites and oesophageal varices (EV) may occur.
Read more
Above 12 mm Hg, there is a risk of variceal bleeding. Carvedilol, a non-selective beta-blocker (NSBB), is recommended in all the patients with cirrhosis and clinically significant PHT in order to prevent decompensation of cirrhosis.
Nevertheless, 40 % of patients are NSBB non-responders, i.e. they do not show a significant decrease in HVPG. In addition, NSBB responders treated for primary prophylaxis have an incidence of variceal bleeding of approximately 10% per year, with a six-week mortality of 20%. Therefore, there is an unmet need for PHT in patients with cirrhosis who do not respond to NSBB, and also for an increase in efficacy in responders. In a randomised pilot study, Rittig et al. observed a mean change in HVPG of -2,9 mm Hg in 16 patients with cirrhosis and HVPG ≥ 12 mm Hg, not treated with NSBB, 90 minutes after ingestion of 1000 mg metformin.
The study will be a prospective, national, multicentre, phase II, superiority comparative randomized (1:1) simple-blinded clinical trial with two parallel arms: metformin versus placebo.
The main objective is to evaluate the effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol.
Subjects randomized in the metformin group or placebo group will receive metformin ou placebo, one pill of 500 mg per os twice a day (one in the morning and one in the evening, during or at the end of the meal) for 28 days.
Read the detailed description
Portal hypertension (PHT) is defined by an elevated pressure gradient between the portal vein and the hepatic veins ≥ 5 mm Hg, and is the main vector of complications in cirrhosis.
When the hepatic venous pressure gradient (HVPG) is ≥ 10 mm Hg, it is considered as a " clinically significant PHT ": ascites and oesophageal varices (EV) may occur.
Above 12 mm Hg, there is a risk of variceal bleeding. Carvedilol, a non-selective beta-blocker (NSBB), is recommended in all the patients with cirrhosis and clinically significant PHT in order to prevent decompensation of cirrhosis.
Nevertheless, 40 % of patients are NSBB non-responders, i.e. they do not show a significant decrease in HVPG. In addition, NSBB responders treated for primary prophylaxis have an incidence of variceal bleeding of approximately 10% per year, with a six-week mortality of 20%. Therefore, there is an unmet need for PHT in patients with cirrhosis who do not respond to NSBB, and also for an increase in efficacy in responders. In a randomised pilot study, Rittig et al. observed a mean change in HVPG of -2,9 mm Hg in 16 patients with cirrhosis and HVPG ≥ 12 mm Hg, not treated with NSBB, 90 minutes after ingestion of 1000 mg metformin.
The study will be a prospective, national, multicentre, phase II, superiority comparative randomized (1:1) simple-blinded clinical trial with two parallel arms: metformin versus placebo.
The main objective is to evaluate the effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol.
There are several secondary objectives in this research listed below:
- evaluate the safety and tolerability of metformin in patients with cirrhosis and a HVPG ≥ 12 mm Hg
- evaluate the rate of change in HVPG after 28 days of treatment
- evaluate the rate of patients with a clinically significant improvement in HVPG
- assess the change in systemic haemodynamics after 28 days of treatment
- assess the change in liver steatosis after 28 days of treatment
- assess the performance of liver and spleen stiffness by vibration-controlled transient elastography (VCTE) using FibroScan® (Echosens, Paris, France) to estimate the haemodynamic response to the treatment
- assess the performance of liver and spleen stiffness by 2D-shear wave elastography using Aixplorer® (SuperSonic Imagine, Aix-en-Provence, France) to estimate the haemodynamic response to the treatment
- assess the effect of metformin on systemic inflammation, coagulation, hepatocyte stress, and endothelial function.
Subjects randomized in the metformin group or placebo group will receive metformin ou placebo, one pill of 500 mg per os twice a day (one in the morning and one in the evening, during or at the end of the meal) for 28 days.
- Being tested
- Metformin, Placebo
- Keywords
- cirrhosis, portal hypertension, metformin, hepatic venous pressure gradient, carvedilol
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
one pill of 500 mg per os twice a day for 28 days.
PlaceboDrug
one pill per os twice a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| METFORMIN GROUP | Experimental | Not described Receives: Drug: Metformin |
| PLACEBO GROUP | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol.
HVPG measures before and after metformin or placebo treatment
Measured: after 28 days of treatment
Secondary outcomes (18)
the rate of patients with a clinically significant improvement in HVPG
Change in arterial pressure after treatment : HVPG > or = 12 mm Hg, or at least a 10% reduction from baseline,
Measured: after 28 days of treatment
Change in cirrhosis severity MELD score
MELD (Model for End-Stage Liver Disease) score classification (6-40 with high score is worse outcome)
Measured: after 28 days of treatment
Change in cirrhosis severity Child-Pugh score
Child-Pugh classification or Child-Turcotte-Pugh classification (5-15 with high score is worse outcome)
Measured: after 28 days of treatment
change in systemic haemodynamics
The size (diameter) of a blood vessel.
Measured: after 28 days of treatment
the tolerability of metformin in patients with cirrhosis and a HVPG ≥ 12 mm Hg
treatment compliance
Measured: after 28 days of treatment
Maximum metformin plasma level
plasma level (at 2h30 of last dose)
Measured: after 28 days of treatment
Relative changes in HVPG
HVPG measure
Measured: day 28
Change in arterial pressure
HVGP
Measured: after 28 days of treatment
the safety of metformin in patients with cirrhosis and a HVPG ≥ 12 mm Hg
complication and adverse event evaluate by CTCAE guideline during treatment
Measured: 30 days after the beginning of treatment
Change in liver steatosis
Controlled Attenuation Parameter with FibroScan®
Measured: after 28 days of treatment
Change in markers of systemic inflammation
Measured: after 28 days of treatment.
Change in markers of hepatocyte stress
hepatocyte large extracellular vesicles
Measured: after 28 days of treatment
Change in markers of endothelial function
Measured: after 28 days of treatment
Change in platelet count
Measured: after 28 days of treatment
Change in liver stiffness by VCTE
using FibroScan®
Measured: after 28 days of treatment
Change in liver stiffness by 2D-shear wave elastography
using Aixplorer®
Measured: after 28 days of treatment
Change in SPLEEN stiffness by VCTE
using FibroScan®
Measured: after 28 days of treatment
Change in spleen stiffness by 2D-shear wave elastography
using Aixplorer®
Measured: after 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start10 Mar 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687265
- Sponsor's protocol ID
- APHP230872
- Acronym
- Hyper-Met
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rittig N, Aagaard NK, Villadsen GE, Sandahl TD, Jessen N, Gronbaek H, George J. Randomised clinical study: acute effects of metformin versus placebo on portal pressure in patients with cirrhosis and portal hypertension. Aliment Pharmacol Ther. 2021 Aug;54(3):320-328. doi: 10.1111/apt.16460. Epub 2021 Jun 24.
PubMed 34165199
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension - A Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06687265
- Acronym / sponsor ID
- Hyper-Met / APHP230872
- Keywords
- cirrhosis, portal hypertension, metformin, hepatic venous pressure gradient, carvedilol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 Nov 2024 (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.
Portal hypertension (PHT) is defined by an elevated pressure gradient between the portal vein and the hepatic veins ≥ 5 mm Hg, and is the main vector of complications in cirrhosis.
When the hepatic venous pressure gradient (HVPG) is ≥ 10 mm Hg, it is considered as a " clinically significant PHT ": ascites and oesophageal varices (EV) may occur.
Above 12 mm Hg, there is a risk of variceal bleeding. Carvedilol, a non-selective beta-blocker (NSBB), is recommended in all the patients with cirrhosis and clinically significant PHT in order to prevent decompensation of cirrhosis.
Nevertheless, 40 % of patients are NSBB non-responders, i.e. they do not show a significant decrease in HVPG. In addition, NSBB responders treated for primary prophylaxis have an incidence of variceal bleeding of approximately 10% per year, with a six-week mortality of 20%. Therefore, there is an unmet need for PHT in patients with cirrhosis who do not respond to NSBB, and also for an increase in efficacy in responders. In a randomised pilot study, Rittig et al. observed a mean change in HVPG of -2,9 mm Hg in 16 patients with cirrhosis and HVPG ≥ 12 mm Hg, not treated with NSBB, 90 minutes after ingestion of 1000 mg metformin.
The study will be a prospective, national, multicentre, phase II, superiority comparative randomized (1:1) simple-blinded clinical trial with two parallel arms: metformin versus placebo.
The main objective is to evaluate the effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol.
Subjects randomized in the metformin group or placebo group will receive metformin ou placebo, one pill of 500 mg per os twice a day (one in the morning and one in the evening, during or at the end of the meal) for 28 days.
Detailed description
Portal hypertension (PHT) is defined by an elevated pressure gradient between the portal vein and the hepatic veins ≥ 5 mm Hg, and is the main vector of complications in cirrhosis.
When the hepatic venous pressure gradient (HVPG) is ≥ 10 mm Hg, it is considered as a " clinically significant PHT ": ascites and oesophageal varices (EV) may occur.
Above 12 mm Hg, there is a risk of variceal bleeding. Carvedilol, a non-selective beta-blocker (NSBB), is recommended in all the patients with cirrhosis and clinically significant PHT in order to prevent decompensation of cirrhosis.
Nevertheless, 40 % of patients are NSBB non-responders, i.e. they do not show a significant decrease in HVPG. In addition, NSBB responders treated for primary prophylaxis have an incidence of variceal bleeding of approximately 10% per year, with a six-week mortality of 20%. Therefore, there is an unmet need for PHT in patients with cirrhosis who do not respond to NSBB, and also for an increase in efficacy in responders. In a randomised pilot study, Rittig et al. observed a mean change in HVPG of -2,9 mm Hg in 16 patients with cirrhosis and HVPG ≥ 12 mm Hg, not treated with NSBB, 90 minutes after ingestion of 1000 mg metformin.
The study will be a prospective, national, multicentre, phase II, superiority comparative randomized (1:1) simple-blinded clinical trial with two parallel arms: metformin versus placebo.
The main objective is to evaluate the effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol.
There are several secondary objectives in this research listed below:
- evaluate the safety and tolerability of metformin in patients with cirrhosis and a HVPG ≥ 12 mm Hg
- evaluate the rate of change in HVPG after 28 days of treatment
- evaluate the rate of patients with a clinically significant improvement in HVPG
- assess the change in systemic haemodynamics after 28 days of treatment
- assess the change in liver steatosis after 28 days of treatment
- assess the performance of liver and spleen stiffness by vibration-controlled transient elastography (VCTE) using FibroScan® (Echosens, Paris, France) to estimate the haemodynamic response to the treatment
- assess the performance of liver and spleen stiffness by 2D-shear wave elastography using Aixplorer® (SuperSonic Imagine, Aix-en-Provence, France) to estimate the haemodynamic response to the treatment
- assess the effect of metformin on systemic inflammation, coagulation, hepatocyte stress, and endothelial function.
Subjects randomized in the metformin group or placebo group will receive metformin ou placebo, one pill of 500 mg per os twice a day (one in the morning and one in the evening, during or at the end of the meal) for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| METFORMIN GROUP | Experimental | Drug: Metformin |
| PLACEBO GROUP | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- - Age ≥ 18 years
- Written informed consent to participate in the study
- Medical insurance coverage
- For child-bearing aged women, contraception using oestroprogestative, progestative, intrauterine device, or mechanical contraception
- Diagnosis of cirrhosis based on a liver biopsy, or on clinical, biological, endoscopic, and radiological evidence
Key exclusion criteria (26 listed)
- Serum total bilirubin > 50 µmol/L
- Prothrombin ratio < 50 %
- Transaminases > 5 ULN
- Need for at least one paracentesis for ascites fluid evacuation in the last 6 months
- Expected follow-up < 3 months
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 |
|---|---|---|
| Metforminone pill of 500 mg per os twice a day for 28 days. | Drug | METFORMIN GROUP |
| Placeboone pill per os twice a day for 28 days. | Drug | PLACEBO GROUP |
Primary outcome
effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol.
Time frame: after 28 days of treatment
HVPG measures before and after metformin or placebo treatment
18 secondary outcomes
the rate of patients with a clinically significant improvement in HVPG
Time frame: after 28 days of treatment
Change in cirrhosis severity MELD score
Time frame: after 28 days of treatment
Change in cirrhosis severity Child-Pugh score
Time frame: after 28 days of treatment
change in systemic haemodynamics
Time frame: after 28 days of treatment
the tolerability of metformin in patients with cirrhosis and a HVPG ≥ 12 mm Hg
Time frame: after 28 days of treatment
Maximum metformin plasma level
Time frame: after 28 days of treatment
Relative changes in HVPG
Time frame: day 28
Change in arterial pressure
Time frame: after 28 days of treatment
the safety of metformin in patients with cirrhosis and a HVPG ≥ 12 mm Hg
Time frame: 30 days after the beginning of treatment
Change in liver steatosis
Time frame: after 28 days of treatment
Change in markers of systemic inflammation
Time frame: after 28 days of treatment.
Change in markers of hepatocyte stress
Time frame: after 28 days of treatment
Change in markers of endothelial function
Time frame: after 28 days of treatment
Change in platelet count
Time frame: after 28 days of treatment
Change in liver stiffness by VCTE
Time frame: after 28 days of treatment
Change in liver stiffness by 2D-shear wave elastography
Time frame: after 28 days of treatment
Change in SPLEEN stiffness by VCTE
Time frame: after 28 days of treatment
Change in spleen stiffness by 2D-shear wave elastography
Time frame: after 28 days of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 34165199Rittig N, Aagaard NK, Villadsen GE, Sandahl TD, Jessen N, Gronbaek H, George J. Randomised clinical study: acute effects of metformin versus placebo on portal pressure in patients with cirrhosis and portal hypertension. Aliment Pharmacol Ther. 2021 Aug;54(3):320-328. doi: 10.1111/apt.16460. Epub 2021 Jun 24.
- Individual participant dataSharing planned: Undecided
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Cirrhosis and Portal Hypertension Related to Cirrhosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 26 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 13 Apr 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LUCILE MOGA (01 71 11 46 69 ext. +33, lucile.moga@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol. (time frame: after 28 days of treatment). 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 NCT06687265, 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 13 Apr 2025.