Alcoholic CirrhosisPhase 2NCT04250259
SAMe Trial for Patients With Alcoholic Cirrhosis
A Phase 2 study testing SAMe 400 mg tablet in people with Alcoholic Cirrhosis, run by Indiana University at 2 sites in United States.
Trial summary
The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Cirrhosis
- What is being tested?
- SAMe 400 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2020to 1 Mar 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and/or histopathology by biopsy and
- subjects with clinical presentation either in Child Class A or B at the time of enrollment
- individuals 18 to 70 years old and may or may not consume alcohol during study.
- ) individuals 18 to 70 years old (2) able to provide informed consent (3) subjects do not consume any alcohol or those who drink < 50 grams per day on average in women and < 80 grams per day on average in men (4) subjects are healthy without underlying acute or chronic medical conditions.
Who cannot join
- Active infection as evidenced by positive urine culture, blood culture, or pneumonia,
- Known co-existing infection with hepatitis C, hepatitis B, or HIV
- Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study
- Gastrointestinal bleeding within the prior 28 days3
- Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
- Women who are pregnant, may become pregnant, or nursing
Show all 15Show fewer
- Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of SAMe such as those with gastric bypass surgery
- Subjects with history of/diagnosis of hepatocellular carcinoma
- Members from the same family of study participant. This is based on the recent paper on the non-random sampling in randomized controlled trials4. We acknowledge that if we assign family members to identical treatment, randomization would not be totally correct; but if properly randomized, there is a chance that the members of the family might mix the pills. To avoid this issue and maintain the integrity of randomized blinded fashion, we will not include members from the same family into the study
- Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and
- Subjects who are immunocompromised
- subjects with an active and serious medical disease
- subjects with an infectious disease
- consume any alcohol within 3 months before the study
- subjects with localized or systemic infection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Indiana University Hospital
Indianapolis, Indiana, 46202
Maggie Hesler, B.S, 317-988-4545, mshesler@iu.edu
Suthat Liangpunsakul, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Brandon Love, 310-423-9917, brandon.love@cshs.org
Shelly Lu, MD
About this study
Official title: A Multi-center, Randomized, Placebo-controlled Trial of S-Adenosylmethionine (SAMe) in Patients With Alcoholic Cirrhosis
The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
- Conditions
- Alcoholic Cirrhosis
- Being tested
- Placebo, SAMe 400 mg tablet
- Keywords
- Child Class A or B
- Medical subject headings
- Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2 tablets of placebo in the morning before breakfast and one tablet of placebo in the evening before dinner for 24 months
SAMe 400 mg tabletDrug
SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Alcoholic Cirrhosis on placebo Receives: Drug: Placebo |
| 1,200 mg SAMe | Experimental | SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months Receives: Drug: SAMe 400 mg tablet |
| Non-drinking Controls | No intervention | Non-drinking healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAMe supplement's effect on all-cause mortality
The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
Measured: Baseline to end of 24 months
Secondary outcomes (9)
SAMe supplement's effect on intestinal permeability function, as defined by serum lipopolysaccharides (LPS)
The function of intestinal permeability will be evaluated by testing serum lipopolysaccharides (LPS) in patients who receive SAMe compared to those who receive placebo. Lipopolysaccharides (LPS) are large molecules consisting of a lipid and a polysaccharide that are bacterial toxins.
Measured: baseline to end of 24 months
SAMe supplement's effect on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by mitochondrial DNA
Cellular oxidative stress and/or endoplasmic reticulum (ER) stress will be evaluated by measuring the levels of mitochondrial DNA in the blood of patients who receive SAMe compared to those who receive placebo.
Measured: baseline to 24 months
SAMe supplement's effect on liver deuteriation
determining Proportion of subjects undergoing liver transplantation in patients who receive SAMe compared to those who receive placebo
Measured: baseline to 24 months
SAMe supplement's effect on liver developing cancer
Proportion of subjects developing new onset hepatocellular carcinoma in patients who receive SAMe compared to those who receive placebo
Measured: baseline to 24 months
SAMe supplement's effect on infections of the liver
Proportion of subjects with infection/sepsis (other than SBP) in patients who receive SAMe compared to those who receive placebo
Measured: baseline to 24 months
SAMe supplement's effect on other parts of the body
capture safety-related endpoints by determining proportion of patients with nausea and emesis, proportion of subjects with unexplained diarrhea in patients receive SAMe compared to those who receive placebo.
Measured: baseline to 24 months
SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD14
The function of intestinal permeability will be evaluated by testing soluble(s) CD14 in patients who receive SAMe compared to those who receive placebo. sCD14 either appears after shedding of mCD14 (48 kDa) or is directly secreted from intracellular vesicles (56 kDa).
Measured: baseline to 24 months
SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD163
The function of intestinal permeability will be evaluated by testing soluble(s) CD163 in patients who receive SAMe compared to those who receive placebo. CD163 is an endocytic receptor for haptoglobin-hemoglobin complexes and is expressed solely on macrophages and monocytes. As a result of ectodomain shedding, the extracellular portion of CD163 circulates in blood as a soluble protein (sCD163).
Measured: baseline to 24 months
SAMe supplement's effects on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by cytochrome P450 2E1 levels
Levels of cellular oxidative stress and/or endoplasmic reticulum (ER) stress will be evaluated by measuring the levels of cytochrome P450 2E1 (CYP2E1) enriched microparticles in patients who receive SAMe compared to those who receive placebo.CYP2E1 is a member of the cytochrome P450 mixed-function oxidase system, which is involved in the metabolism of xenobiotics in the body.
Measured: baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start22 Oct 2020
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic CirrhosisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Suthat Liangpunsakul, Indiana University
- Investigators
- Suthat Liangpunsakul, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250259
- Sponsor's protocol ID
- SAMe Trial
- Other IDs
- 5U01AA026817-04
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2020
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Placebo-controlled Trial of S-Adenosylmethionine (SAMe) in Patients With Alcoholic Cirrhosis
- ClinicalTrials.gov ID
- NCT04250259
- Acronym / sponsor ID
- SAMe Trial
- Conditions
- Alcoholic Cirrhosis
- Keywords
- Child Class A or B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 31 Jan 2020 (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.
The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAlcoholic Cirrhosis on placebo |
| 1,200 mg SAMe | Experimental | Drug: SAMe 400 mg tabletSAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months |
| Non-drinking Controls | No intervention | –Non-drinking healthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and/or histopathology by biopsy and
- subjects with clinical presentation either in Child Class A or B at the time of enrollment
- individuals 18 to 70 years old and may or may not consume alcohol during study.
- ) individuals 18 to 70 years old (2) able to provide informed consent (3) subjects do not consume any alcohol or those who drink < 50 grams per day on average in women and < 80 grams per day on average in men (4) subjects are healthy without underlying acute or chronic medical conditions.
Key exclusion criteria (15 listed)
- Active infection as evidenced by positive urine culture, blood culture, or pneumonia,
- Known co-existing infection with hepatitis C, hepatitis B, or HIV
- Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study
- Gastrointestinal bleeding within the prior 28 days3
- Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
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 |
|---|---|---|
| Placebo2 tablets of placebo in the morning before breakfast and one tablet of placebo in the evening before dinner for 24 months | Drug | Placebo |
| SAMe 400 mg tabletSAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months | Drug | 1,200 mg SAMe |
Primary outcome
SAMe supplement's effect on all-cause mortality
Time frame: Baseline to end of 24 months
The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
9 secondary outcomes
SAMe supplement's effect on intestinal permeability function, as defined by serum lipopolysaccharides (LPS)
Time frame: baseline to end of 24 months
SAMe supplement's effect on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by mitochondrial DNA
Time frame: baseline to 24 months
SAMe supplement's effect on liver deuteriation
Time frame: baseline to 24 months
SAMe supplement's effect on liver developing cancer
Time frame: baseline to 24 months
SAMe supplement's effect on infections of the liver
Time frame: baseline to 24 months
SAMe supplement's effect on other parts of the body
Time frame: baseline to 24 months
SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD14
Time frame: baseline to 24 months
SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD163
Time frame: baseline to 24 months
SAMe supplement's effects on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by cytochrome P450 2E1 levels
Time frame: baseline to 24 months
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 31 Mar 2026.
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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.
Suthat Liangpunsakul, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAMe 400 mg tablet in people with Alcoholic Cirrhosis, run by Indiana University at 2 sites in United States.
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 4 inclusion and 15 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Maggie Hesler, B.S ((317) 988-4545, mshesler@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAMe supplement's effect on all-cause mortality (time frame: Baseline to end of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.