Nonalcoholic Fatty Liver DiseasePhase 2NCT04710524
FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
A Phase 2 study testing FM101 150 mg BID and FM101 300 mg BID in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Future Medicine at 12 sites in 3 countries.
Trial summary
A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- What is being tested?
- FM101 150 mg BID and FM101 300 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 10 Jun 2021to 31 Aug 2023
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must meet all of the following criteria to be included in the study:
- Be able and willing to provide written informed consent to take part in the study, and to comply with all the study's requirements.
- Be a man or woman ≥18 years of age at screening.
- Have c. Histologic confirmation of NASH no more than 12 months before the screening visit date, demonstrating the existence of steatosis ≥5%, hepatocyte ballooning and chronic inflammation (at least 1 point for each component), and stage 1 through stage 3 liver fibrosis according to the NASH Clinical Research Network (CRN); OR d. NAFLD based upon demonstration of at least 3 of the following 5 components of the metabolic syndrome below, at screening:
- Fasting plasma glucose ≥100 mg/dL , or undergoing drug treatment for elevated plasma glucose concentrations
- High-density lipoprotein-cholesterol (HDL-c) concentration <40 mg/dL in male patients, or <50 mg/dL in female patients, or undergoing drug treatment for reduced serum HDL-c concentrations
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- Serum triglyceride (TG) concentration ≥150 mg/dL, or undergoing drug treatment for elevated serum TG concentrations
- Waist circumference >102 cm in male patients or >88 cm in female patients
- Systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥85 mm Hg, or undergoing drug treatment for hypertension, or antihypertensive drug treatment in a patient with a history of systemic hypertension
- Serum ALT concentration >1 × upper limit of normal (ULN) at screening
- Undergo MRI-PDFF that demonstrates ≥8% liver steatosis during the screening period.
- Undergo MRE with a score ≥2.9 kPa during the screening period.
- Women of childbearing potential (WoCBP) must have a negative serum beta human chorionic gonadotropin (HCG) test result at screening.
- Female patients must agree to use highly effective birth control throughout the study and up to 30 days after the last dose of study drug has been taken. Highly effective contraception measures include the following, but not limited to:
- Combined estrogen- and progestogen-containing hormonal contraception (oral, intravaginal and transdermal);
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable);
- Intrauterine device, intrauterine hormone-releasing system, bilateral tubal, occlusion ('tubal occlusion' includes 'tubal ligation');
- Vasectomized partner (only in the event that the vasectomized partner is the sole sexual partner of the WoCBP);
- Sexual abstinence (defined as refraining from heterosexual intercourse) only in the event that this is the preferred lifestyle of the patient.
- Childbearing potential is defined as being fertile following menarche and until becoming postmenopausal unless permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
- A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause.
- Men with partners who are WOCBP must either be surgically sterile or agree to use a barrier contraceptive for the duration of the study and up to 30 days after the last dose of study drug.
- Be willing to maintain a stable diet, including alcohol intake this applies, and physical activity throughout the entire study.
Who cannot join
- Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study:
- Any patient who refuses to provide written informed consent to take part in the study, and/or appears unwilling to comply with study-specific requirements.
- Female persons who are pregnant, or are breastfeeding at screening, or who plan to become pregnant during the study.
- Body mass index (BMI) <25 kg/m2.
- Fibrosis-4 index (FIB-4) >2.6 at screening.
- Any of the following laboratory test abnormalities at screening:
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- Serum ALT and/or AST concentration >5 × upper limit of normal (ULN)
- Total serum bilirubin (BR) concentration >ULN; if an established diagnosis of Gilbert's syndrome exists and the direct serum BR result at screening is less than or equal to ULN the patient may participate in the study
- Serum albumin concentration ≤3.5 g/dL
- International normalized ratio (INR) ≥1.3
- Platelet count less than the lower limit of normal range (LLN)
- Creatinine clearance rate <60 mL/minute as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation
- Positive COVID-19 polymerase chain reaction (PCR) test result at screening NOTE: Repeat testing of a given parameter or parameters that returned ineligible results, may be performed during the same screening period in consultation with the sponsor's Medical Monitor. An interval of at least 7 days should exist between receipt of the ineligible test result and re-testing.
- Chronic liver disease other than confirmed or suspected NASH, including but not limited to the following diagnoses / entities:
- Chronic hepatitis B virus infection (defined by the presence of hepatitis B surface antigen at screening) and / or chronic hepatitis C virus (HCV) infection (defined by the presence of detectable HCV ribonucleic acid (RNA) antibody [anti-HCV] at screening). Patients whose anti-HCV antibody test at screening is positive, but who test negative for HCV RNA at screening will be permitted to participate in the study as long as there has been evidence of viral negativity for at least 24 months prior to screening)
- Autoimmune hepatitis (AIH), or confirmed overlap syndrome of AIH and either primary biliary cholangitis or primary sclerosing cholangitis.
- Primary biliary cholangitis, primary sclerosing cholangitis, secondary sclerosing cholangitis whatever the basis for this, e.g. chronic pancreatitis resulting in bile duct stricture formation, recurrent extrahepatic bile duct calculus formation, arterial insult resulting in bile duct stricture formation
- Wilson's disease, homozygous alpha-1-anti-trypsin deficiency, hemochromatosis, drug-induced liver disease
- Alcoholic liver disease
- Suspected or confirmed hepatocellular carcinoma
- Medical, histologic, and/or imaging history of hepatic cirrhosis.
- Clinical, endoscopic, imaging and/or laboratory manifestations of portal hypertension, such as spider nevi, splenomegaly, clinically evident ascites formation, non-bleeding gastro-oesophageal varices.
- Known history of human immunodeficiency virus (HIV) infection.
- Chronic use (≥12 months) of any drug known to be associated with development of NAFLD during the five years before the anticipated Day 1 visit date, e.g. amiodarone, methotrexate, systemic glucocorticoids (unless employed at physiologic replacement doses for management of confirmed adrenal insufficiency), tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement therapy, anabolic steroids (other than testosterone replacement preparations being taken at a physiologic replacement dose for management of confirmed male hypogonadism), sodium valproate, and other hepatotoxins, e.g. minocycline.
- Use of the following medications:
- GLP-1 agonists, unless on a stable dose for at least 3 months prior to screening
- Thiazolidinediones, obeticholic acid or vitamin E at a daily dose >400 IU daily within the 6 months before screening
- Statin therapy and other lipid-modifying therapies must have been used at a stable dose for ≥3 months prior to screening
- Oral antidiabetic medication(s) (other than those specifically excluded) must have been used / taken at a stable daily dose for ≥3 months prior to screening
- History of significant alcohol consumption, defined as an average of >20 g/day in female patients and >30 g/day in male patients, for a period of >3 consecutive months within 1 year prior to screening, hazardous alcohol use (Alcohol Use Disorders Identification Test score ≥8), or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
- Active substance abuse within the 1 year before the screening visit date, upon the judgement of the investigator.
- Weight change ≥7% within the 6 months prior to screening or ≥5% within the 3 months prior to screening.
- Prior or planned (during the study period) weight reduction surgery, e.g. sleeve gastrectomy, Roux-en-Y gastrojejunostomy.
- Type 1 diabetes mellitus by medical history.
- Poorly controlled type 2 diabetes mellitus (this is defined as hemoglobin A1c (HbA1c) >9.5% at screening, or a patient whose oral anti-diabetic medication dosing requires adjustment >10% less than 2 months before the screening visit date.
- Uncontrolled systemic hypertension (either treated or untreated) defined as systolic blood pressure >160 mmHg or a diastolic blood pressure >100 mmHg at screening. A retest of blood pressure, (after establishing good blood pressure control within a reasonable period of time and up to the Baseline visit) is permissible at the discretion of the Investigator.
- Patients who demonstrate recent evidence (within 6 months of the anticipated date of the Day 1 visit) of clinically evident and significant atheromatous cardiovascular disease, e.g. unstable angina, acute coronary syndrome, myocardial infarction, cerebrovascular accident [stroke], cerebrovascular ischemia, transient ischemic attack, and / or peripheral vascular disease requiring intervention.
- Has taken part in a clinical trial and been administered an active investigational product being evaluated for the treatment of NASH, weight reduction and / or type 2 diabetes mellitus, during the 6 months prior to the anticipated Day 1 visit date.
- Has participated in an investigational new drug trial during the 30 days prior to screening visit date, or within 5 half-lives of an investigational agent, whichever is longer.
- Has a confirmed diagnosis of malignancy within 5 years prior to screening, except for basal- or squamous-cell carcinoma of the skin that has been treated successfully, or cervical carcinoma in situ that has been treated successfully. Patients with a history of other malignancies that have been treated with curative intent and who have no demonstrable disease recurrence within 5 years prior to screening may also be eligible if approved following discussion with the Sponsor's Medical Monitor. Patients under evaluation for malignant disease currently are not eligible for study participation.
- Patients who are unable to undergo MRI studies, whatever the reason for this, e.g. claustrophobia, the presence of a device or implant that would make imaging dangerous for the patient.
- Any other condition which, in the opinion of the Investigator, would impede compliance with, hinder completion of the study, compromise the well-being of the patient, and / or interfere with the study's endpoints.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Poland5 sites, 5 recruiting
- Recruiting
Krakowskie Centrum Medyczne sp z o.o.
Krakow
Piotr Rozpondek
- Recruiting
ID Clinic Arkadiusz Pisula
Mysłowice
Ewa Janczewska
- Recruiting
Warsaw IBD Point Profesor Kierkus
Warsaw
Jaroslaw Kierkus
- Recruiting
Centrum Medyczne K2J2
Wołomin
Krzysztof Kuc
- Recruiting
Centrum Badan Klinicznych Piotr Napora lekarze
Wroclaw
Krzysztof Simon
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona
Juan Manuel Pericas
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander
Javier Crespo Garcia
- Recruiting
Hospital Universitario Virgen del Rocio (HUVR)
Seville
Manuel Romero-Gomez
- Recruiting
Consorcio Hospital General Universitario de Valencia
Valencia
Moises Diago Madrid
- Recruiting
Hospital Clnico Universitario de Valencia
Valencia
Maria Desamparados Escudero-Garcia
Hungary2 sites, 2 recruiting
- Recruiting
Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika
Budapest
Klára Werling, Dr.
- Recruiting
West Health Kft.,
Budapest
Tibor Gyökeres, Dr.
About this study
Official title: A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
- Being tested
- Placebo, FM101 150 mg BID, FM101 300 mg BID
- Keywords
- Nonalcoholic Fatty Liver Disease, NAFLD, Nonalcoholic Steatohepatitis, NASH, FM101
- 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.
PlaceboDrug
Placebo BID for 13 weeks
FM101 150 mg BIDDrug
FM101 (150 mg) BID for 13 weeks
FM101 300 mg BIDDrug
FM101 (300 mg) BID for 13 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | orally administer placebo BID for 13 weeks except on Day 91 subject receive a single dose Receives: Drug: Placebo |
| FM101 150 mg BID | Experimental | orally administer FM101 150mg BID for 13 weeks except on Day 91 subject receive a single dose Receives: Drug: FM101 150 mg BID |
| FM101 300 mg BID | Experimental | orally administer FM101 300mg BID for 13 weeks except on Day 91 subject receive a single dose Receives: Drug: FM101 300 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with NAFLD or NASH
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
Measured: Day 1 through Day 106
To assess the treatment effect of FM101 on serum ALT concentrations during 13 weeks of treatment
Changes in serum ALT level
Measured: Day 1 through Day 91
Secondary outcomes (1)
To assess the effect of 13 weeks of treatment with FM101 on the change in liver stiffness (kPa) measured by magnetic resonance imaging-magnetic resonance elastography (MRI MRE) in patients with NAFLD or NASH
Change in liver stiffness on MRE
Measured: Day 1 through Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start10 Jun 2021
- Primary completion31 May 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- WanSeok Jeong, MBA, Study chair, Future Medicine Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710524
- Sponsor's protocol ID
- FM101-CTP2-001
- Status last verified
- Jun 2022
- First submitted
- 7 Sep 2020
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT04710524
- Acronym / sponsor ID
- FM101-CTP2-001
- Keywords
- Nonalcoholic Fatty Liver Disease, NAFLD, Nonalcoholic Steatohepatitis, NASH, FM101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Future MedicineIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 14 Jan 2021 (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.
A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboorally administer placebo BID for 13 weeks except on Day 91 subject receive a single dose |
| FM101 150 mg BID | Experimental | Drug: FM101 150 mg BIDorally administer FM101 150mg BID for 13 weeks except on Day 91 subject receive a single dose |
| FM101 300 mg BID | Experimental | Drug: FM101 300 mg BIDorally administer FM101 300mg BID for 13 weeks except on Day 91 subject receive a single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Be able and willing to provide written informed consent to take part in the study, and to comply with all the study's requirements.
- Be a man or woman ≥18 years of age at screening.
- Have c. Histologic confirmation of NASH no more than 12 months before the screening visit date, demonstrating the existence of steatosis ≥5%, hepatocyte ballooning and chronic inflammation (at least 1 point for each component), and stage 1 through stage 3 liver fibrosis according to the NASH Clinical Research Network (CRN); OR d. NAFLD based upon demonstration of at least 3 of the following 5 components of the metabolic syndrome below, at screening:
- Serum ALT concentration >1 × upper limit of normal (ULN) at screening
- Undergo MRI-PDFF that demonstrates ≥8% liver steatosis during the screening period.
Key exclusion criteria (42 listed)
- Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study:
- Any patient who refuses to provide written informed consent to take part in the study, and/or appears unwilling to comply with study-specific requirements.
- Female persons who are pregnant, or are breastfeeding at screening, or who plan to become pregnant during the study.
- Body mass index (BMI) <25 kg/m2.
- Fibrosis-4 index (FIB-4) >2.6 at 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 |
|---|---|---|
| PlaceboPlacebo BID for 13 weeks | Drug | Placebo |
| FM101 150 mg BIDFM101 (150 mg) BID for 13 weeks | Drug | FM101 150 mg BID |
| FM101 300 mg BIDFM101 (300 mg) BID for 13 weeks | Drug | FM101 300 mg BID |
Primary outcome
To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with NAFLD or NASH
Time frame: Day 1 through Day 106
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
To assess the treatment effect of FM101 on serum ALT concentrations during 13 weeks of treatment
Time frame: Day 1 through Day 91
Changes in serum ALT level
1 secondary outcome
To assess the effect of 13 weeks of treatment with FM101 on the change in liver stiffness (kPa) measured by magnetic resonance imaging-magnetic resonance elastography (MRI MRE) in patients with NAFLD or NASH
Time frame: Day 1 through Day 91
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- 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.
WanSeok Jeong, MBA study chair
Future Medicine Co., Ltd.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FM101 150 mg BID and FM101 300 mg BID in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Future Medicine at 12 sites in 3 countries.
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 23 inclusion and 42 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: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Poland, Spain, Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saehan Kang, MS (+82232873805, saehan@futuremedicine.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with NAFLD or NASH (time frame: Day 1 through Day 106). The study lists 2 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 1 Jul 2022.