Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 1MASLDNCT07488975
Developing Microbial Therapy for MASLD: From Mechanism to Clinical Validation
A Phase 1 study testing Pasteurized Akkermansia muciniphila LWHK0003_low dose, Pasteurized Akkermansia muciniphila LWHK0003_medium dose and Pasteurized Akkermansia muciniphila LWHK0003_high dose in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Leeuwenhoek Laboratories Co. Ltd. at 1 site in Taiwan.
Trial summary
Metabolic dysfunction-associated steatotic liver disease (MASLD), redefined in 2020, is an improved diagnostic standard evolved from non-alcoholic fatty liver disease (NAFLD), emphasizing the correlation between hepatic steatosis and metabolic dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Pasteurized Akkermansia muciniphila LWHK0003_low dose, Pasteurized Akkermansia muciniphila LWHK0003_medium dose and Pasteurized Akkermansia muciniphila LWHK0003_high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jan 2025to 31 Dec 2026
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibroscan，CAP ≧ 260db/m
Who cannot join
- Pregnant women or women who are breastfeeding. B. Use of probiotics and prebiotic-related products (including yogurt, yogurt, Yakult, etc.) within 14 days before the screening visit.
- Patients who have used antibiotics (except skin lotions) or antifungal drugs within 30 days before the screening visit.
- Use of glucagon-like peptide-1 receptor agonists (GLP1-RAs) within six months prior to the screening visit.
- Use of drugs that may affect the evaluation index within 14 days before the screening visit, during the screening visit, or during the planned trial period, such as steroids, immunosuppressants, or anti-inflammatory drugs, or drugs containing ingredients for treating hepatitis or affecting fat metabolism, including HMG-CoA reductase inhibitors (statins), fibrates, silymarin, thiazolidinediones, metformin, cholestyramine, ezetimibe, orlistat, and sodium-glucose transporter type 2 inhibitors (SGLT2i). This restriction does not apply if the above-mentioned drugs have been used continuously for more than six months and the dosage is not changed during the trial.
- Those who have had severe gastrointestinal infection diarrhea symptoms within 14 days before the screening visit (more than three watery stools in 24 hours).
- Have the following medical history or laboratory abnormalities:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Microbial Therapeutics for Metabolic Dysfunction-Associated Steatotic Liver Disease: From Mechanistic Investigations to Clinical Trials
Metabolic dysfunction-associated steatotic liver disease (MASLD), redefined in 2020, is an improved diagnostic standard evolved from non-alcoholic fatty liver disease (NAFLD), emphasizing the correlation between hepatic steatosis and metabolic dysfunction. Compared to NAFLD, which relies on exclusion-based diagnosis, MASLD criteria enhance population homogeneity in studies and accommodate patients with coexisting liver diseases, thereby improving the efficiency and relevance of drug development. MASLD affects approximately one-quarter of the global population. If left untreated, it may progress to liver fibrosis, cirrhosis, or hepatocellular carcinoma. Given its high clinical burden and the current lack of FDA-approved therapies, effective treatments for MASLD are urgently needed.
Previous studies suggest that diet and gut microbiota play crucial roles in the pathogenesis of MASLD. Dietary composition influences microbial balance and intestinal barrier function. In dysbiosis, gut-derived harmful substances such as pathogen-associated molecular patterns (PAMPs) and microbiota-derived metabolites (MDMs) may translocate via a leaky gut to the liver through the portal vein, contributing to hepatic injury. These processes, often described as the gut-liver axis, remain incompletely understood.
Read more
Animal studies have shown that dietary components regulating gut microbiota may help alleviate MASLD. While clinical evidence remains limited, incorporating microbiota-modulating and immune-regulating food ingredients holds potential. Next-generation probiotics have demonstrated benefits in improving hepatic lipid metabolism and modulating gut microbiota, potentially slowing MASLD progression through gut-liver axis modulation.
Our previous research investigated a pasteurized Akkermansia muciniphila strain, NTUH_Amuc03 (pAKK_LWHK0003), which attenuated fatty liver progression in preclinical models. In mice subjected to a high-fat, high-fructose, high-cholesterol diet, pAKK_LWHK0003 administration resulted in reduced body weight, improved dyslipidemia, lowered NAFLD activity scores, and improved HOMA-IR. These findings support the potential of pAKK_LWHK0003 in slowing MASLD progression.
This study aims to evaluate further the clinical efficacy and safety of pAKK_LWHK0003 in individuals with MASLD.
Read the detailed description
The aim of this study was to evaluate the effects of administering indigenously derived inactivated Akkermansia muciniphila (pAKK_LWHK0003) on improving fatty liver in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and to assess its clinical safety.
- Being tested
- Pasteurized Akkermansia muciniphila LWHK0003_low dose, Pasteurized Akkermansia muciniphila LWHK0003_medium dose, Pasteurized Akkermansia muciniphila LWHK0003_high dose, Placebo
- Keywords
- MASLD, MASH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized Akkermansia muciniphila LWHK0003_low doseBiological
400 mg/capsule/days. Duration: 120 days
Pasteurized Akkermansia muciniphila LWHK0003_medium doseBiological
400 mg/capsule/day. Duration: 120 days
Pasteurized Akkermansia muciniphila LWHK0003_high doseBiological
400 mg/capsule/day. Duration: 120 days
PlaceboOther
400 mg/capsule/day. Duration: 120 days
| Study group | Role | What they receive |
|---|---|---|
| Pasteurized Akkermansia muciniphila LWHK0003 _low dose | Experimental | 400 mg/capsule/day. Duration: 120 days Receives: Biological: Pasteurized Akkermansia muciniphila LWHK0003_low dose |
| Pasteurized Akkermansia muciniphila LWHK0003 _medium dose | Experimental | 400 mg/capsule/day. Duration: 120 days Receives: Biological: Pasteurized Akkermansia muciniphila LWHK0003_medium dose |
| Pasteurized Akkermansia muciniphila LWHK0003 _high dose | Experimental | 400 mg/capsule/day. Duration: 120 days Receives: Biological: Pasteurized Akkermansia muciniphila LWHK0003_high dose |
| Placebo | Placebo comparator | 400 mg/capsule/day. Duration: 120 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver steatosis, fibrosis, liver stiffness, and FIB-4 index
To assess the statistical differences between baseline and Weeks 12 and 16 (Visit V5 and V6) after administration of placebo or different doses (10⁹, 10¹⁰, 10¹¹ CFU) of pAKK LWHK0003 capsules, in terms of liver fat content (steatosis), fibrosis, liver stiffness, and FIB-4 index as measured by FibroScan and MRI/MRE.
Measured: From enrollment to the end of treatment, up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start22 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeuwenhoek Laboratories Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488975
- Sponsor's protocol ID
- LL-IRB-2403
- Acronym
- MASLD
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Microbial Therapeutics for Metabolic Dysfunction-Associated Steatotic Liver Disease: From Mechanistic Investigations to Clinical Trials
- ClinicalTrials.gov ID
- NCT07488975
- Acronym / sponsor ID
- MASLD / LL-IRB-2403
- Keywords
- MASLD, MASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Leeuwenhoek Laboratories Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (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.
Metabolic dysfunction-associated steatotic liver disease (MASLD), redefined in 2020, is an improved diagnostic standard evolved from non-alcoholic fatty liver disease (NAFLD), emphasizing the correlation between hepatic steatosis and metabolic dysfunction. Compared to NAFLD, which relies on exclusion-based diagnosis, MASLD criteria enhance population homogeneity in studies and accommodate patients with coexisting liver diseases, thereby improving the efficiency and relevance of drug development. MASLD affects approximately one-quarter of the global population. If left untreated, it may progress to liver fibrosis, cirrhosis, or hepatocellular carcinoma. Given its high clinical burden and the current lack of FDA-approved therapies, effective treatments for MASLD are urgently needed.
Previous studies suggest that diet and gut microbiota play crucial roles in the pathogenesis of MASLD. Dietary composition influences microbial balance and intestinal barrier function. In dysbiosis, gut-derived harmful substances such as pathogen-associated molecular patterns (PAMPs) and microbiota-derived metabolites (MDMs) may translocate via a leaky gut to the liver through the portal vein, contributing to hepatic injury. These processes, often described as the gut-liver axis, remain incompletely understood.
Animal studies have shown that dietary components regulating gut microbiota may help alleviate MASLD. While clinical evidence remains limited, incorporating microbiota-modulating and immune-regulating food ingredients holds potential. Next-generation probiotics have demonstrated benefits in improving hepatic lipid metabolism and modulating gut microbiota, potentially slowing MASLD progression through gut-liver axis modulation.
Our previous research investigated a pasteurized Akkermansia muciniphila strain, NTUH_Amuc03 (pAKK_LWHK0003), which attenuated fatty liver progression in preclinical models. In mice subjected to a high-fat, high-fructose, high-cholesterol diet, pAKK_LWHK0003 administration resulted in reduced body weight, improved dyslipidemia, lowered NAFLD activity scores, and improved HOMA-IR. These findings support the potential of pAKK_LWHK0003 in slowing MASLD progression.
This study aims to evaluate further the clinical efficacy and safety of pAKK_LWHK0003 in individuals with MASLD.
Detailed description
The aim of this study was to evaluate the effects of administering indigenously derived inactivated Akkermansia muciniphila (pAKK_LWHK0003) on improving fatty liver in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and to assess its clinical safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pasteurized Akkermansia muciniphila LWHK0003 _low dose | Experimental | Biological: Pasteurized Akkermansia muciniphila LWHK0003_low dose400 mg/capsule/day. Duration: 120 days |
| Pasteurized Akkermansia muciniphila LWHK0003 _medium dose | Experimental | Biological: Pasteurized Akkermansia muciniphila LWHK0003_medium dose400 mg/capsule/day. Duration: 120 days |
| Pasteurized Akkermansia muciniphila LWHK0003 _high dose | Experimental | Biological: Pasteurized Akkermansia muciniphila LWHK0003_high dose400 mg/capsule/day. Duration: 120 days |
| Placebo | Placebo comparator | Other: Placebo400 mg/capsule/day. Duration: 120 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fibroscan，CAP ≧ 260db/m
Key exclusion criteria (6 listed)
- Pregnant women or women who are breastfeeding. B. Use of probiotics and prebiotic-related products (including yogurt, yogurt, Yakult, etc.) within 14 days before the screening visit.
- Patients who have used antibiotics (except skin lotions) or antifungal drugs within 30 days before the screening visit.
- Use of glucagon-like peptide-1 receptor agonists (GLP1-RAs) within six months prior to the screening visit.
- Use of drugs that may affect the evaluation index within 14 days before the screening visit, during the screening visit, or during the planned trial period, such as steroids, immunosuppressants, or anti-inflammatory drugs, or drugs containing ingredients for treating hepatitis or affecting fat metabolism, including HMG-CoA reductase inhibitors (statins), fibrates, silymarin, thiazolidinediones, metformin, cholestyramine, ezetimibe, orlistat, and sodium-glucose transporter type 2 inhibitors (SGLT2i). This restriction does not apply if the above-mentioned drugs have been used continuously for more than six months and the dosage is not changed during the trial.
- Those who have had severe gastrointestinal infection diarrhea symptoms within 14 days before the screening visit (more than three watery stools in 24 hours).
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 |
|---|---|---|
| Pasteurized Akkermansia muciniphila LWHK0003_low dose400 mg/capsule/days. Duration: 120 days | Biological | Pasteurized Akkermansia muciniphila LWHK0003 _low dose |
| Pasteurized Akkermansia muciniphila LWHK0003_medium dose400 mg/capsule/day. Duration: 120 days | Biological | Pasteurized Akkermansia muciniphila LWHK0003 _medium dose |
| Pasteurized Akkermansia muciniphila LWHK0003_high dose400 mg/capsule/day. Duration: 120 days | Biological | Pasteurized Akkermansia muciniphila LWHK0003 _high dose |
| Placebo400 mg/capsule/day. Duration: 120 days | Other | Placebo |
Primary outcome
Liver steatosis, fibrosis, liver stiffness, and FIB-4 index
Time frame: From enrollment to the end of treatment, up to 52 weeks
To assess the statistical differences between baseline and Weeks 12 and 16 (Visit V5 and V6) after administration of placebo or different doses (10⁹, 10¹⁰, 10¹¹ CFU) of pAKK LWHK0003 capsules, in terms of liver fat content (steatosis), fibrosis, liver stiffness, and FIB-4 index as measured by FibroScan and MRI/MRE.
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 26 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pasteurized Akkermansia muciniphila LWHK0003_low dose, Pasteurized Akkermansia muciniphila LWHK0003_medium dose and Pasteurized Akkermansia muciniphila LWHK0003_high dose in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Leeuwenhoek Laboratories Co. Ltd. at 1 site in Taiwan.
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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 26 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 Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Liver steatosis, fibrosis, liver stiffness, and FIB-4 index (time frame: From enrollment to the end of treatment, up to 52 weeks). 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 26 Aug 2026.