Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension

Q: Who can participate in NCT06687265?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06687265?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension - A Randomized Placebo-controlled Study

Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension (NCT06687265) is a Phase 2 interventional studying Cirrhosis and Portal Hypertension Related to Cirrhosis, sponsored by Assistance Publique - Hôpitaux de Paris. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Cirrhosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 76 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cirrhosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - \- Age ≥ 18 years - Written willing to sign a consent form 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 - Child-Pugh A or B - High likelihood of HVPG ≥ 12 mm Hg based on investigator's judgement, or on the following criteria: 1. Investigator's judgement 2. 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 3. 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 Should NOT Join This Trial: - Serum total bilirubin \> 50 µmol/L - Prothrombin ratio \< 50 % - Transaminases \> 5 ULN ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * \- 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 * Child-Pugh A or B * High likelihood of HVPG ≥ 12 mm Hg based on investigator's judgement, or on the following criteria: 1. Investigator's judgement 2. 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 3. 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 Exclusion Criteria: * 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 * 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

Treatments Being Tested

DRUG

Metformin

one pill of 500 mg per os twice a day for 28 days.

DRUG

Placebo

one pill per os twice a day for 28 days.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Facility Name: Beaujon hospital

Clichy, France, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06687265), the sponsor (Assistance Publique - Hôpitaux de Paris), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06687265 clinical trial studying?

Who can participate in NCT06687265?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06687265?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06687265. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06687265. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.