MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)Phase 2NCT03938246

Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

A Phase 2 study testing TVB-2640 25 mg (US), TVB-2640 50 mg (US) and TVB-2640 50 mg (China) in people with MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), run by Sagimet Biosciences Inc. at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
What is being tested?: TVB-2640 25 mg (US), TVB-2640 50 mg (US) and TVB-2640 50 mg (China)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 142 participants
Where: 23 sitesin 2 countries
Study dates: 22 Mar 2019to 2 Oct 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Aged ≥ 18 years with a body mass index (BMI) ≤40 kg/m2.
Prior liver biopsy within 24 months of randomization with fibrosis Stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
Steatosis
Ballooning degeneration
Lobular inflammation
AND

Show all 11Show fewer

Confirmation of ≥ 8% liver fat content on MRI-PDFF.
OR, if prior biopsy is not available:
Either overweight or obese or diabetic or ALT ≥ 30 U/L or fatty liver on ultrasound and at least one more feature of metabolic syndrome by Adult Treatment Panel III (ATP III) criteria.
AND
Magnetic resonance elastography (MRE) ≥ 2.5 kPa and MRI-PDFF ≥ 8% during screening.

Who cannot join

Subjects meeting any of the following criteria are not eligible for enrollment in the study.
History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.
Note: Significant alcohol consumption is defined as average of > 20 g/day in female subjects and > 30 g/day in male subjects.
Type 1 diabetes.
Uncontrolled Type 2 diabetes defined as:
HbA1c ≥ 9.5% during screening. (Subjects with HbA1c ≥ 9.5% may be rescreened).

Show all 11Show fewer

Basal insulin dose adjustment > 10% within 60 days prior to enrollment.
Requirement for glucagon-like peptide analogue or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) within 6 months of screening.
History of severe hypoglycemia (symptomatic hypoglycemia requiring outside assistance to regain normal neurologic status) within the previous year.
Note: Individual diabetes regimens will be reviewed by Investigator and may be adjusted based on American Diabetes Association guidelines.
Presence of cirrhosis on liver biopsy (Stage 4 fibrosis) or imaging.

Trial locations and contacts

23 sites in 2 countries.

Country

City, postcode or hospital

23 sites in 2 countries

United States12 sites

Texas Diabetes and Endocrinology - Austin
Austin, Texas, 78749
Texas Digestive Disease Consultants - Cedar Park
Cedar Park, Texas, 78613
ProSciento
Chula Vista, California, 91911
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, 75246
Texas Digestive Disease Consultant - Ft Worth
Fort Worth, Texas, 76104
Panax
Miami Lakes, Florida, 33014
Catalina Research Institute
Montclair, California, 91763
Lucas Research
Morehead City, North Carolina, 28557
Clinical Trials Research
Sacramento, California, 95821
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
University of California San Diego (UCSD)
San Diego, California, 92037
Texas Digestive Disease Consultants - Webster
Webster, Texas, 77598

Other trials in United States

China11 sites

Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Foshan First People's Hospital
Foshan, Guangdong, 528000
Nanfang Hospital
Guangzhou, Guangdong, 510080
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310015
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210000
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200336
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200336
Shanghai Tongren Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200336

Other trials in China

About this study

Official title: A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (FASCINATE-1)

This is a Phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. Subjects will be randomly assigned to 1 of 2 treatment groups (TVB-2640 at one of three doses or placebo). Following randomization, subjects will begin the 12-week treatment period and will receive once daily TVB-2640 or placebo.

Conditions: MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
Being tested: TVB-2640 25 mg (US), TVB-2640 50 mg (US), Placebo (US), TVB-2640 50 mg (China), Placebo (China)
Keywords: NASH, Non-Alcoholic Steatohepatitis, Fatty Liver Disease, Fatty Liver, Liver Diseases, FASN, Fatty Acid Synthase Inhibitor
Medical subject headings: Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TVB-2640 25 mg (US)Drug
Oral dose, tablet, daily dosing
TVB-2640 50 mg (US)Drug
Oral dose, tablet, daily dosing
Placebo (US)Drug
Oral dose, tablet, daily dosing
TVB-2640 50 mg (China)Drug
Oral dose, tablet, daily dosing
Placebo (China)Drug
Oral dose, tablet, daily dosing
TVB-2640 75 mg (US)Drug
Oral dose, tablet, daily dosing

Study groups in NCT03938246
Study group	Role	What they receive
TVB-2640 25 mg (US)	Experimental	Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). Receives: Drug: TVB-2640 25 mg (US)
TVB-2640 50 mg (US)	Experimental	Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). Receives: Drug: TVB-2640 50 mg (US)
Placebo (US)	Placebo comparator	Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640. Receives: Drug: Placebo (US)
TVB-2640 50 mg (China)	Experimental	Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). Receives: Drug: TVB-2640 50 mg (China)
Placebo (China)	Placebo comparator	Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640. Receives: Drug: Placebo (China)
TVB-2640 75 mg (US)	Experimental	After completion of Cohorts 1 and 2, and if no stopping criteria are met upon review by the Independent SRC, an additional TVB-2640 75 mg open-label Cohort 3 will open in the US Receives: Drug: TVB-2640 75 mg (US)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline
As determined by MRI-PDFF
Measured: 12 weeks

Secondary outcomes (2)

Percentage of Subjects With at Least a 30% Reduction in Liver Fat at Week 12.
As determined by MRI-PDFF
Measured: 12 weeks
Percentage of Change From Baseline in Alanine Aminotransferase (ALT)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 20192 Oct 2021

First posted6 May 2019
Study start22 Mar 2019
Primary completion2 Oct 2021
Study completion2 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)Studies 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be randomly assigned to experimental or placebo arms.
Masking: Single blind
Who is masked: Participant
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03938246
Sponsor's protocol ID: 3V2640-CLIN-005
Status last verified: Dec 2024
First submitted: 24 Apr 2019
Last updated: 19 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Loomba R, Mohseni R, Lucas KJ, Gutierrez JA, Perry RG, Trotter JF, Rahimi RS, Harrison SA, Ajmera V, Wayne JD, O'Farrell M, McCulloch W, Grimmer K, Rinella M, Wai-Sun Wong V, Ratziu V, Gores GJ, Neuschwander-Tetri BA, Kemble G. TVB-2640 (FASN Inhibitor) for the Treatment of Nonalcoholic Steatohepatitis: FASCINATE-1, a Randomized, Placebo-Controlled Phase 2a Trial. Gastroenterology. 2021 Nov;161(5):1475-1486. doi: 10.1053/j.gastro.2021.07.025. Epub 2021 Jul 23.
PubMed 34310978

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

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

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (FASCINATE-1)
ClinicalTrials.gov ID: NCT03938246
Acronym / sponsor ID: 3V2640-CLIN-005
Conditions: MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
Keywords: NASH, Non-Alcoholic Steatohepatitis, Fatty Liver Disease, Fatty Liver, Liver Diseases, FASN, Fatty Acid Synthase Inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Sagimet Biosciences Inc.Industry (pharma, biotech, devices)
Study start: 22 Mar 2019 (actual)
Primary completion: 2 Oct 2021 (actual)
Study completion: 2 Oct 2021 (actual)
First posted: 6 May 2019 (actual)
Results: Posted 19 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 6
Model description: Subjects will be randomly assigned to experimental or placebo arms.

Arm	Type	Receives
TVB-2640 25 mg (US)	Experimental	Drug: TVB-2640 25 mg (US)Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours).
TVB-2640 50 mg (US)	Experimental	Drug: TVB-2640 50 mg (US)Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours).
Placebo (US)	Placebo comparator	Drug: Placebo (US)Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640.
TVB-2640 50 mg (China)	Experimental	Drug: TVB-2640 50 mg (China)Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours).
Placebo (China)	Placebo comparator	Drug: Placebo (China)Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640.
TVB-2640 75 mg (US)	Experimental	Drug: TVB-2640 75 mg (US)After completion of Cohorts 1 and 2, and if no stopping criteria are met upon review by the Independent SRC, an additional TVB-2640 75 mg open-label Cohort 3 will open in the US

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Aged ≥ 18 years with a body mass index (BMI) ≤40 kg/m2.
Prior liver biopsy within 24 months of randomization with fibrosis Stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
AND
Confirmation of ≥ 8% liver fat content on MRI-PDFF.
Either overweight or obese or diabetic or ALT ≥ 30 U/L or fatty liver on ultrasound and at least one more feature of metabolic syndrome by Adult Treatment Panel III (ATP III) criteria.

Key exclusion criteria (11 listed)

Subjects meeting any of the following criteria are not eligible for enrollment in the study.
History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.
Note: Significant alcohol consumption is defined as average of > 20 g/day in female subjects and > 30 g/day in male subjects.
Type 1 diabetes.
Uncontrolled Type 2 diabetes defined as:

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
TVB-2640 25 mg (US)Oral dose, tablet, daily dosing	Drug	TVB-2640 25 mg (US)
TVB-2640 50 mg (US)Oral dose, tablet, daily dosing	Drug	TVB-2640 50 mg (US)
Placebo (US)Oral dose, tablet, daily dosing	Drug	Placebo (US)
TVB-2640 50 mg (China)Oral dose, tablet, daily dosing	Drug	TVB-2640 50 mg (China)
Placebo (China)Oral dose, tablet, daily dosing	Drug	Placebo (China)
TVB-2640 75 mg (US)Oral dose, tablet, daily dosing	Drug	TVB-2640 75 mg (US)

Primary outcome

Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline
Time frame: 12 weeks
As determined by MRI-PDFF

2 secondary outcomes

Percentage of Subjects With at Least a 30% Reduction in Liver Fat at Week 12.
Time frame: 12 weeks
Percentage of Change From Baseline in Alanine Aminotransferase (ALT)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 19 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TVB-2640 25 mg (US)	33	27
TVB-2640 50 mg (US)	35	30
Placebo (US)	31	31
TVB-2640 50 mg (China)	21	20
Placebo (China)	9	9
TVB-2640 75 mg (US)	13	11

Primary outcome: Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline

Time frame: 12 weeks. Mean (Standard Deviation). Unit: percent change from baseline

Measure	TVB-2640 25 mg (US) n = 26	TVB-2640 50 mg (US) n = 27	Placebo (US) n = 23	TVB-2640 50 mg (China) n = 19	Placebo (China) n = 7	TVB-2640 75 mg (US) n = 7
Value	-11.31 (29.837)	-27.59 (28.354)	2.52 (33.030)	-28.68 (22.265)	-15.63 (30.789)	-35.77 (23.736)

Population analysed: Analyses using only subjects in the mITT Population who had data at Baseline and Week 12 for observed relative change values from Baseline to Week 12

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TVB-2640 25 mg (US)	0 of 33 (0%)	25 of 33 (75.8%)	0 of 33
TVB-2640 50 mg (US)	0 of 35 (0%)	14 of 35 (40%)	0 of 35
Placebo (US)	0 of 31 (0%)	12 of 31 (38.7%)	0 of 31
TVB-2640 50 mg (China)	0 of 21 (0%)	17 of 21 (81%)	0 of 21
Placebo (China)	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
TVB-2640 75 mg (US)	0 of 13 (0%)	9 of 13 (69.2%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34310978Loomba R, Mohseni R, Lucas KJ, Gutierrez JA, Perry RG, Trotter JF, Rahimi RS, Harrison SA, Ajmera V, Wayne JD, O'Farrell M, McCulloch W, Grimmer K, Rinella M, Wai-Sun Wong V, Ratziu V, Gores GJ, Neuschwander-Tetri BA, Kemble G. TVB-2640 (FASN Inhibitor) for the Treatment of Nonalcoholic Steatohepatitis: FASCINATE-1, a Randomized, Placebo-Controlled Phase 2a Trial. Gastroenterology. 2021 Nov;161(5):1475-1486. doi: 10.1053/j.gastro.2021.07.025. Epub 2021 Jul 23.
Individual participant dataSharing planned: No

Related trials for MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

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.

Rohit Loomba, MD principal investigator

UCSD

23 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 11 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, China. 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?

Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline (time frame: 12 weeks). 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 NCT03938246, 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 19 Dec 2024.