Non-Alcoholic Fatty Liver DiseaseNCT06176079
Hyperpolarized Pyruvate (13C) Magnetic Resonance Imaging In Patients With Fatty Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease and Non Alcoholic Fatty Liver, run by Michael Ohliger, MD PhD at 1 site in United States.
Trial summary
The recent development of dissolution dynamic nuclear polarization (DNP) technology for hyperpolarized (HP) 13C imaging offers a promising new avenue for non-invasively accessing fundamental metabolic changes associated with the progression of fatty liver disease in vivo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non Alcoholic Steatohepatitis
- What is being tested?
- Hyperpolarized (HP) 13C, Hyperpolarized 13C-Urea and Magnetic Resonance Imaging
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2020to 28 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with diagnosed NASH or NAFLD, or adult healthy volunteers.
Who may be able to join
- Part 1 (Imaging Optimization):
- Able and willing to sign informed consent.
- Age >= 18 years old at the time of study entry.
- Part 2 (Pilot Study):
- Group 1 (Fatty Liver Patients without NASH):
- NAFL as determined by either clinical suspicion of fatty liver disease based on:
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- steatosis by imaging or histology,
- no significant alcohol consumption,
- absence of coexisting liver disease OR NAFL determined by liver biopsy 3 months prior to the scan, with the presence of fat on histology but absent ballooning or fibrosis. (nonalcoholic steatohepatitis activity score (NAS) <= 3).
- Able and willing to sign informed consent.
- Age ≥ 18 years old at the time of study entry.
- Alcohol consumption < 2 drinks/day for men and <1 drink/day for women
- Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV) antibody, human immunodeficiency virus (HIV) antibody negative.
- Serum alanine aminotransferase (ALT) < 400 microliter (uL)
- Group 2 (NASH Patients):
- NASH as determined by liver biopsy 3 months prior to the scan.
- NASH defined as NAS score greater than or equal to 4 with confirmation of NASH by an anatomic pathologist.
- Able and willing to sign informed consent.
- Age >= 18 years old at the time of study entry.
- Alcohol consumption < 2 drinks/day for men and <1 drink/day for women
- HBsAg, HCV antibody, HIV antibody negative.
- Group 3 (Healthy volunteer):
- No known history of diabetes or liver disease.
- Able and willing to sign informed consent.
- Age >= 18 years old at the time of study entry.
- Body mass index < 25.
- Liver panel normal (aspartate aminotransferase (AST), ALT, alkaline phosphatase, bilirubin).
- HBsAg, HCV antibody, HIV antibody negative.
- Hemoglobin A1c < 5.7%.
- Estimated glomerular filtration rate (eGFR) >= 60 mL/min/1.73m^2
Who cannot join
- Part 1 (Imaging Optimization): For Cohorts 1/B only:
- Poorly controlled hypertension, with blood pressure at study entry > 160 mmHg systolic or > 100 mmHg diastolic.
- Congestive heart failure with New York Heart Association (NYHA) status ≥ 2.
- Pregnant or nursing.
- Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including participants with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
- Participant size too large to fit in MR scanner.
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- Part 2 (Pilot Study): All groups
- Poorly controlled hypertension, with blood pressure at study entry > 160 mmHg systolic or > 100 mmHg diastolic.
- Current treatment with oral medication for diabetes.
- Pregnant or nursing.
- Participants unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
- Participant size too large to fit in MR scanner.
- Congestive heart failure with New York Heart Association (NYHA) status >= 2.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Pilot Study of Magnetic Resonance Imaging With Hyperpolarized Pyruvate (13C) In Patients With Fatty Liver Disease
The recent development of dissolution dynamic nuclear polarization (DNP) technology for hyperpolarized (HP) 13C imaging offers a promising new avenue for non-invasively accessing fundamental metabolic changes associated with the progression of fatty liver disease in vivo. The purpose of this pilot study is to optimize sequence parameters for hyperpolarized 13C acquisition in the human liver and determine which metabolic changes can be seen in humans with simple, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) when compared to healthy volunteers.
Read the detailed description
PRIMARY OBJECTIVES:
- Optimize scan parameters in order to maximize the signal-to-noise ratio of the HP 13C-pyruvate magnetic resonance imaging (MRI) in the liver.
- Determine whether the level of lactate production (as measured by the lactate/pyruvate ratio) in NASH participants, participants with simple NAFL, and healthy volunteers.
SECONDARY OBJECTIVES:
- Develop data analysis methods to quantify HP C-13 pyruvate MRI data.
- Further characterize the safety profile of HP C-13 pyruvate injections.
EXPLORATORY OBJECTIVES:
- Examine the impact of the dual liver blood supply on the vascular kinetics of observed hyperpolarized 13C metabolism.
- Improve methods of quantification and motion correction for hyperpolarized 13C acquisition, incorporating perfusion information derived from 13C Urea
OUTLINE:
Part 1: (Imaging Optimization, N=50): Participants enrolled in Part 1 will predominantly be healthy volunteers. As the protocol optimization is completed, there is a possibility that testing in using data from participants with fatty liver disease may be performed. Participants in this part will be divided into two cohorts:
- Cohort A: Participants will undergo MRI but no injection of hyperpolarized 13C.
- Cohort B: Participants will receive one HP 13C injection. Participants in this cohort will have the option of undergoing repeated dose imaging studies of HP 13C-pyruvate or HP 13C-pyruvate+HP 13C-urea "copol", for up to a total of two injections per imaging visit.
Part 2: (Pilot Study, N=30): Participants enrolled in Part 2 will receive the HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" protocol that was optimized in Part 1 as well as standard liver MRI pulse sequences. Participants will be stratified into the following groups based on diagnosis:
- Group 1 (n=10): Participants with a diagnosis of non-alcoholic fatty liver without steatohepatitis (NAFL)
- Group 2 (n=10): Participants with a diagnosis of non-alcoholic steatohepatitis (NASH)
- Group 3 (n=10): Participants with no known liver disease (healthy volunteers)
Participants will be followed for 2-4 days following imaging procedure.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non Alcoholic Steatohepatitis, NAFLD, NASH
- Being tested
- Hyperpolarized (HP) 13C, Hyperpolarized 13C-Urea, Magnetic Resonance Imaging, Saline Flush
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized (HP) 13CDrug
Also called HP 13C
A dosage of 0.43 mL/kg body weight at the maximum dosage will be injected intravenously at a rate of 5 mL/second.
Hyperpolarized 13C-UreaDrug
Also called HP13C-urea, copol
Given intravenously (IV)
Magnetic Resonance ImagingProcedure or surgery
Also called MRI, MR
Imaging procedure
Saline FlushProcedure or surgery
A 20 milliliter (mL) saline flush at 5 mL/second will be given after each dose of HP 13C
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Cohort A): No injection of hyperpolarized (HP) 13C | Participants who are comprised of, primarily, healthy volunteers will undergo a standard MRI scan. Receives: Procedure: Magnetic Resonance Imaging | |
| Part 1 (Cohort B): Injection of hyperpolarized (HP) 13C or HP13C-pyruvate+HP13C-urea "copol" | Participants will receive HP 13C injection, and receive an MRI scan. Imaging results will be used to optimize the hyperpolarized 13C part of the imaging procedure. Participants will also have the option of undergoing repeated dose imaging studies of HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol", (up to a total of two injections per imaging visit separated by 15-60 minutes). Participants may be asked to fast up to 6 hours prior to the scan and the initial HP 13C MRI scan may be taken while participants are in a fasted state. Participants who have fasted will be offered up to 20 ounces (oz) of an oral glucose, fructose, or other high calorie drink (i.e. Gatorade, Coca-Cola, Ensure, etc.) to increase blood glucose levels, and a second HP 13C MRI scan will be performed after caloric intake. Receives: Drug: Hyperpolarized (HP) 13C; Drug: Hyperpolarized 13C-Urea; Procedure: Magnetic Resonance Imaging; Procedure: Saline Flush | |
| Part 2 (Group 1): NAFLD | Participants with diagnosed NAFLD will receive HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" injection optimized in Part 1 of the study as well as standard liver MRI pulse sequences. Receives: Drug: Hyperpolarized (HP) 13C; Drug: Hyperpolarized 13C-Urea; Procedure: Magnetic Resonance Imaging; Procedure: Saline Flush | |
| Part 2 (Group 2): NASH | Participants with diagnosed NASH will receive HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" injection optimized in Part 1 of the study as well as standard liver MRI pulse sequences. Receives: Drug: Hyperpolarized (HP) 13C; Drug: Hyperpolarized 13C-Urea; Procedure: Magnetic Resonance Imaging; Procedure: Saline Flush | |
| Part 2 (Group 3): Healthy Volunteers | Healthy volunteers without known liver disease will receive HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" injection optimized in Part 1 of the study as well as standard liver MRI pulse sequences. Receives: Drug: Hyperpolarized (HP) 13C; Drug: Hyperpolarized 13C-Urea; Procedure: Magnetic Resonance Imaging; Procedure: Saline Flush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal coil placement (Part 1)
Establishing suitable radiofrequency (RF) coils for individual applications and proper use of MRI techniques such as parallel imaging to achieve optimal image quality will be conducted during the participant's scan. There is no formal analytic plan for Part 1 of the study, which is focused on optimizing the image acquisition protocol.
Measured: 1 day
Optimal pulse sequences (Part 1)
Establishing the pulse sequences for individual applications and proper use of MRI techniques such as parallel imaging to achieve optimal image quality will be conducted during the participant's scan. There is no formal analytic plan for Part 1 of the study, which is focused on optimizing the image acquisition protocol.
Measured: 1 day
Optimal respiratory parameter (Part 1)
Establishing the magnitude of respiratory motion for individual applications and proper use of MRI techniques such as parallel imaging to achieve optimal image quality will be conducted during the participant's scan. There is no formal analytic plan for Part 1 of the study, which is focused on optimizing the image acquisition protocol.
Measured: 1 day
Mean lactate/pyruvate conversion rate (kPL) (Part 1, Cohort B)
Mean lactate-to-pyruvate conversion will be calculated with 95% confidence intervals.
Measured: 1 day
Signal-to-noise ratio (SNR) (Part 1, Cohort B)
SNR will be calculated..
Measured: 1 day
Mean lactate-to-pyruvate ratio (Part 2)
The mean lactate-to-pyruvate ratio will be calculated for each of the diagnostic groups: (1) NAFL without steatohepatitis, (2) NASH, and (3) healthy volunteers.
Measured: 1 day
Mean kPL(Part 2)
The mean kPL will be calculated for each of the diagnostic groups: (1) NAFL without steatohepatitis, (2) NASH, and (3) healthy volunteers.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start22 Jul 2020
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Ohliger, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Ohliger, MD PhD, University of California, San Francisco
- Investigators
- Michael Ohliger, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176079
- Sponsor's protocol ID
- 19-29381
- Other IDs
- 5R01DK115987
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Magnetic Resonance Imaging With Hyperpolarized Pyruvate (13C) In Patients With Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06176079
- Acronym / sponsor ID
- 19-29381
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non Alcoholic Steatohepatitis, NAFLD, NASH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Michael Ohliger, MD PhDUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 19 Dec 2023 (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 recent development of dissolution dynamic nuclear polarization (DNP) technology for hyperpolarized (HP) 13C imaging offers a promising new avenue for non-invasively accessing fundamental metabolic changes associated with the progression of fatty liver disease in vivo. The purpose of this pilot study is to optimize sequence parameters for hyperpolarized 13C acquisition in the human liver and determine which metabolic changes can be seen in humans with simple, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) when compared to healthy volunteers.
Detailed description
PRIMARY OBJECTIVES:
- Optimize scan parameters in order to maximize the signal-to-noise ratio of the HP 13C-pyruvate magnetic resonance imaging (MRI) in the liver.
- Determine whether the level of lactate production (as measured by the lactate/pyruvate ratio) in NASH participants, participants with simple NAFL, and healthy volunteers.
SECONDARY OBJECTIVES:
- Develop data analysis methods to quantify HP C-13 pyruvate MRI data.
- Further characterize the safety profile of HP C-13 pyruvate injections.
EXPLORATORY OBJECTIVES:
- Examine the impact of the dual liver blood supply on the vascular kinetics of observed hyperpolarized 13C metabolism.
- Improve methods of quantification and motion correction for hyperpolarized 13C acquisition, incorporating perfusion information derived from 13C Urea
OUTLINE:
Part 1: (Imaging Optimization, N=50): Participants enrolled in Part 1 will predominantly be healthy volunteers. As the protocol optimization is completed, there is a possibility that testing in using data from participants with fatty liver disease may be performed. Participants in this part will be divided into two cohorts:
- Cohort A: Participants will undergo MRI but no injection of hyperpolarized 13C.
- Cohort B: Participants will receive one HP 13C injection. Participants in this cohort will have the option of undergoing repeated dose imaging studies of HP 13C-pyruvate or HP 13C-pyruvate+HP 13C-urea "copol", for up to a total of two injections per imaging visit.
Part 2: (Pilot Study, N=30): Participants enrolled in Part 2 will receive the HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" protocol that was optimized in Part 1 as well as standard liver MRI pulse sequences. Participants will be stratified into the following groups based on diagnosis:
- Group 1 (n=10): Participants with a diagnosis of non-alcoholic fatty liver without steatohepatitis (NAFL)
- Group 2 (n=10): Participants with a diagnosis of non-alcoholic steatohepatitis (NASH)
- Group 3 (n=10): Participants with no known liver disease (healthy volunteers)
Participants will be followed for 2-4 days following imaging procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Cohort A): No injection of hyperpolarized (HP) 13C | – | Procedure: Magnetic Resonance ImagingParticipants who are comprised of, primarily, healthy volunteers will undergo a standard MRI scan. |
| Part 1 (Cohort B): Injection of hyperpolarized (HP) 13C or HP13C-pyruvate+HP13C-urea "copol" | – | Drug: Hyperpolarized (HP) 13C, Drug: Hyperpolarized 13C-Urea, Procedure: Magnetic Resonance Imaging, Procedure: Saline FlushParticipants will receive HP 13C injection, and receive an MRI scan. Imaging results will be used to optimize the hyperpolarized 13C part of the imaging procedure. Participants will also have the option of undergoing repeated dose imaging studies of HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol", (up to a total of two injections per imaging visit separated by 15-60 minutes). Participants may be asked to fast up to 6 hours prior to the scan and the initial HP 13C MRI scan may be taken while participants are in a fasted state. Participants who have fasted will be offered up to 20 ounces (oz) of an oral glucose, fructose, or other high calorie drink (i.e. Gatorade, Coca-Cola, Ensure, etc.) to increase blood glucose levels, and a second HP 13C MRI scan will be performed after caloric intake. |
| Part 2 (Group 1): NAFLD | – | Drug: Hyperpolarized (HP) 13C, Drug: Hyperpolarized 13C-Urea, Procedure: Magnetic Resonance Imaging, Procedure: Saline FlushParticipants with diagnosed NAFLD will receive HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" injection optimized in Part 1 of the study as well as standard liver MRI pulse sequences. |
| Part 2 (Group 2): NASH | – | Drug: Hyperpolarized (HP) 13C, Drug: Hyperpolarized 13C-Urea, Procedure: Magnetic Resonance Imaging, Procedure: Saline FlushParticipants with diagnosed NASH will receive HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" injection optimized in Part 1 of the study as well as standard liver MRI pulse sequences. |
| Part 2 (Group 3): Healthy Volunteers | – | Drug: Hyperpolarized (HP) 13C, Drug: Hyperpolarized 13C-Urea, Procedure: Magnetic Resonance Imaging, Procedure: Saline FlushHealthy volunteers without known liver disease will receive HP 13C-pyruvate or HP13C-pyruvate+HP13C-urea "copol" injection optimized in Part 1 of the study as well as standard liver MRI pulse sequences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosed NASH or NAFLD, or adult healthy volunteers.
Key inclusion criteria (30 listed)
- Able and willing to sign informed consent.
- Age >= 18 years old at the time of study entry.
- Group 1 (Fatty Liver Patients without NASH):
- Group 2 (NASH Patients):
- Group 3 (Healthy volunteer):
Key exclusion criteria (13 listed)
- Poorly controlled hypertension, with blood pressure at study entry > 160 mmHg systolic or > 100 mmHg diastolic.
- Congestive heart failure with New York Heart Association (NYHA) status ≥ 2.
- Pregnant or nursing.
- Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including participants with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
- Participant size too large to fit in MR scanner.
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 |
|---|---|---|
| Hyperpolarized (HP) 13CAlso: HP 13CA dosage of 0.43 mL/kg body weight at the maximum dosage will be injected intravenously at a rate of 5 mL/second. | Drug | Part 1 (Cohort B): Injection of hyperpolarized (HP) 13C or HP13C-pyruvate+HP13C-urea "copol", Part 2 (Group 1): NAFLD, Part 2 (Group 2): NASH, Part 2 (Group 3): Healthy Volunteers |
| Hyperpolarized 13C-UreaAlso: HP13C-urea, copolGiven intravenously (IV) | Drug | Part 1 (Cohort B): Injection of hyperpolarized (HP) 13C or HP13C-pyruvate+HP13C-urea "copol", Part 2 (Group 1): NAFLD, Part 2 (Group 2): NASH, Part 2 (Group 3): Healthy Volunteers |
| Magnetic Resonance ImagingAlso: MRI, MRImaging procedure | Procedure or surgery | Part 1 (Cohort A): No injection of hyperpolarized (HP) 13C, Part 1 (Cohort B): Injection of hyperpolarized (HP) 13C or HP13C-pyruvate+HP13C-urea "copol", Part 2 (Group 1): NAFLD, Part 2 (Group 2): NASH, Part 2 (Group 3): Healthy Volunteers |
| Saline FlushA 20 milliliter (mL) saline flush at 5 mL/second will be given after each dose of HP 13C | Procedure or surgery | Part 1 (Cohort B): Injection of hyperpolarized (HP) 13C or HP13C-pyruvate+HP13C-urea "copol", Part 2 (Group 1): NAFLD, Part 2 (Group 2): NASH, Part 2 (Group 3): Healthy Volunteers |
Primary outcome
Optimal coil placement (Part 1)
Time frame: 1 day
Establishing suitable radiofrequency (RF) coils for individual applications and proper use of MRI techniques such as parallel imaging to achieve optimal image quality will be conducted during the participant's scan. There is no formal analytic plan for Part 1 of the study, which is focused on optimizing the image acquisition protocol.
Optimal pulse sequences (Part 1)
Time frame: 1 day
Establishing the pulse sequences for individual applications and proper use of MRI techniques such as parallel imaging to achieve optimal image quality will be conducted during the participant's scan. There is no formal analytic plan for Part 1 of the study, which is focused on optimizing the image acquisition protocol.
Optimal respiratory parameter (Part 1)
Time frame: 1 day
Establishing the magnitude of respiratory motion for individual applications and proper use of MRI techniques such as parallel imaging to achieve optimal image quality will be conducted during the participant's scan. There is no formal analytic plan for Part 1 of the study, which is focused on optimizing the image acquisition protocol.
Mean lactate/pyruvate conversion rate (kPL) (Part 1, Cohort B)
Time frame: 1 day
Mean lactate-to-pyruvate conversion will be calculated with 95% confidence intervals.
Signal-to-noise ratio (SNR) (Part 1, Cohort B)
Time frame: 1 day
SNR will be calculated..
Mean lactate-to-pyruvate ratio (Part 2)
Time frame: 1 day
The mean lactate-to-pyruvate ratio will be calculated for each of the diagnostic groups: (1) NAFL without steatohepatitis, (2) NASH, and (3) healthy volunteers.
Mean kPL(Part 2)
Time frame: 1 day
The mean kPL will be calculated for each of the diagnostic groups: (1) NAFL without steatohepatitis, (2) NASH, and (3) healthy volunteers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael Ohliger, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Non Alcoholic Fatty Liver, run by Michael Ohliger, MD PhD at 1 site 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 30 inclusion and 13 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: finished, as of the sponsor's last update on 3 Aug 2026. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal coil placement (Part 1) (time frame: 1 day). The study lists 7 primary outcomes in all. 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 3 Aug 2026.