FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
NCT ID: NCT04710524
Last Updated: 2022-07-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-06-10
Study Completion Date
2023-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis
NCT00470171
Serum Levels of ALAT Transaminases
Serum Markers for Fibrosis and Hepatic Inflammation
COMPLETED
PHASE2
A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis
NCT04004325
Nonalcoholic Steatohepatitis (NASH)
Overweight or Obesity
TERMINATED
PHASE1/PHASE2
A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
NCT03776175
Non-Alcoholic Fatty Liver Disease (NAFLD)
COMPLETED
PHASE2
A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis
NCT05939947
Advanced Liver Fibrosis
Liver Cirrhosis
COMPLETED
PHASE1
Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients
NCT01811472
Non-alcoholic Fatty Liver Disease (NAFLD)
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
orally administer placebo BID for 13 weeks except on Day 91 subject receive a single dose
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo BID for 13 weeks
FM101 150 mg BID
orally administer FM101 150mg BID for 13 weeks except on Day 91 subject receive a single dose
Group Type
EXPERIMENTAL
FM101 150 mg BID
Intervention Type
DRUG
FM101 (150 mg) BID for 13 weeks
FM101 300 mg BID
orally administer FM101 300mg BID for 13 weeks except on Day 91 subject receive a single dose
Group Type
EXPERIMENTAL
FM101 300 mg BID
Intervention Type
DRUG
FM101 (300 mg) BID for 13 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Placebo BID for 13 weeks
Intervention Type
DRUG
FM101 150 mg BID
FM101 (150 mg) BID for 13 weeks
Intervention Type
DRUG
FM101 300 mg BID
FM101 (300 mg) BID for 13 weeks
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Individuals must meet all of the following criteria to be included in the study:
1. Be able and willing to provide written informed consent to take part in the study, and to comply with all the study's requirements.
2. Be a man or woman ≥18 years of age at screening.
3. 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
* 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
4. Serum ALT concentration \>1 × upper limit of normal (ULN) at screening
5. Undergo MRI-PDFF that demonstrates ≥8% liver steatosis during the screening period.
6. Undergo MRE with a score ≥2.9 kPa during the screening period.
7. 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.
8. Be willing to maintain a stable diet, including alcohol intake this applies, and physical activity throughout the entire study.
1. Be able and willing to provide written informed consent to take part in the study, and to comply with all the study's requirements.
2. Be a man or woman ≥18 years of age at screening.
3. 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
* 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
4. Serum ALT concentration \>1 × upper limit of normal (ULN) at screening
5. Undergo MRI-PDFF that demonstrates ≥8% liver steatosis during the screening period.
6. Undergo MRE with a score ≥2.9 kPa during the screening period.
7. 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.
8. Be willing to maintain a stable diet, including alcohol intake this applies, and physical activity throughout the entire study.
Exclusion Criteria
Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study:
1. 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.
2. Female persons who are pregnant, or are breastfeeding at screening, or who plan to become pregnant during the study.
3. Body mass index (BMI) \<25 kg/m2.
4. Fibrosis-4 index (FIB-4) \>2.6 at screening.
5. Any of the following laboratory test abnormalities at screening:
1. Serum ALT and/or AST concentration \>5 × upper limit of normal (ULN)
2. 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
3. Serum albumin concentration ≤3.5 g/dL
4. International normalized ratio (INR) ≥1.3
5. Platelet count less than the lower limit of normal range (LLN)
6. Creatinine clearance rate \<60 mL/minute as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation
7. 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.
6. Chronic liver disease other than confirmed or suspected NASH, including but not limited to the following diagnoses / entities:
1. 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)
2. Autoimmune hepatitis (AIH), or confirmed overlap syndrome of AIH and either primary biliary cholangitis or primary sclerosing cholangitis.
3. 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
4. Wilson's disease, homozygous alpha-1-anti-trypsin deficiency, hemochromatosis, drug-induced liver disease
5. Alcoholic liver disease
6. Suspected or confirmed hepatocellular carcinoma
7. Medical, histologic, and/or imaging history of hepatic cirrhosis.
8. Clinical, endoscopic, imaging and/or laboratory manifestations of portal hypertension, such as spider nevi, splenomegaly, clinically evident ascites formation, non-bleeding gastro-oesophageal varices.
9. Known history of human immunodeficiency virus (HIV) infection.
10. 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.
11. Use of the following medications:
1. GLP-1 agonists, unless on a stable dose for at least 3 months prior to screening
2. Thiazolidinediones, obeticholic acid or vitamin E at a daily dose \>400 IU daily within the 6 months before screening
3. Statin therapy and other lipid-modifying therapies must have been used at a stable dose for ≥3 months prior to screening
4. 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
12. 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.
13. Active substance abuse within the 1 year before the screening visit date, upon the judgement of the investigator.
14. Weight change ≥7% within the 6 months prior to screening or ≥5% within the 3 months prior to screening.
15. Prior or planned (during the study period) weight reduction surgery, e.g. sleeve gastrectomy, Roux-en-Y gastrojejunostomy.
16. Type 1 diabetes mellitus by medical history.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. 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.
1. 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.
2. Female persons who are pregnant, or are breastfeeding at screening, or who plan to become pregnant during the study.
3. Body mass index (BMI) \<25 kg/m2.
4. Fibrosis-4 index (FIB-4) \>2.6 at screening.
5. Any of the following laboratory test abnormalities at screening:
1. Serum ALT and/or AST concentration \>5 × upper limit of normal (ULN)
2. 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
3. Serum albumin concentration ≤3.5 g/dL
4. International normalized ratio (INR) ≥1.3
5. Platelet count less than the lower limit of normal range (LLN)
6. Creatinine clearance rate \<60 mL/minute as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation
7. 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.
6. Chronic liver disease other than confirmed or suspected NASH, including but not limited to the following diagnoses / entities:
1. 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)
2. Autoimmune hepatitis (AIH), or confirmed overlap syndrome of AIH and either primary biliary cholangitis or primary sclerosing cholangitis.
3. 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
4. Wilson's disease, homozygous alpha-1-anti-trypsin deficiency, hemochromatosis, drug-induced liver disease
5. Alcoholic liver disease
6. Suspected or confirmed hepatocellular carcinoma
7. Medical, histologic, and/or imaging history of hepatic cirrhosis.
8. Clinical, endoscopic, imaging and/or laboratory manifestations of portal hypertension, such as spider nevi, splenomegaly, clinically evident ascites formation, non-bleeding gastro-oesophageal varices.
9. Known history of human immunodeficiency virus (HIV) infection.
10. 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.
11. Use of the following medications:
1. GLP-1 agonists, unless on a stable dose for at least 3 months prior to screening
2. Thiazolidinediones, obeticholic acid or vitamin E at a daily dose \>400 IU daily within the 6 months before screening
3. Statin therapy and other lipid-modifying therapies must have been used at a stable dose for ≥3 months prior to screening
4. 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
12. 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.
13. Active substance abuse within the 1 year before the screening visit date, upon the judgement of the investigator.
14. Weight change ≥7% within the 6 months prior to screening or ≥5% within the 3 months prior to screening.
15. Prior or planned (during the study period) weight reduction surgery, e.g. sleeve gastrectomy, Roux-en-Y gastrojejunostomy.
16. Type 1 diabetes mellitus by medical history.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Future Medicine
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
WanSeok Jeong, MBA
Role: STUDY_CHAIR
Future Medicine Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika
Budapest, , Hungary
Site Status
RECRUITING
West Health Kft.,
Budapest, , Hungary
Site Status
RECRUITING
Krakowskie Centrum Medyczne sp z o.o.
Krakow, , Poland
Site Status
RECRUITING
ID Clinic Arkadiusz Pisula
Mysłowice, , Poland
Site Status
RECRUITING
Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Site Status
RECRUITING
Centrum Medyczne K2J2
Wołomin, , Poland
Site Status
RECRUITING
Centrum Badan Klinicznych Piotr Napora lekarze
Wroclaw, , Poland
Site Status
RECRUITING
Hospital Universitari Vall d Hebron
Barcelona, , Spain
Site Status
RECRUITING
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Site Status
RECRUITING
Hospital Universitario Virgen del Rocio (HUVR)
Seville, , Spain
Site Status
RECRUITING
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Site Status
RECRUITING
Hospital Clnico Universitario de Valencia
Valencia, , Spain
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Hungary
Poland
Spain
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Tibor Gyökeres, Dr.
Role: primary
Piotr Rozpondek
Role: primary
Ewa Janczewska
Role: primary
Jaroslaw Kierkus
Role: primary
Krzysztof Kuc
Role: primary
Krzysztof Simon
Role: primary
Juan Manuel Pericas
Role: primary
Javier Crespo Garcia
Role: primary
Manuel Romero-Gomez
Role: primary
Moises Diago Madrid
Role: primary
Maria Desamparados Escudero-Garcia
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FM101-CTP2-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Phase 2b Study of Icosabutate in Fatty Liver Disease
NCT04052516
COMPLETED
PHASE2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
NCT04171765
TERMINATED
PHASE2
Nonalcoholic Fatty Liver Disease (NAFLD) Pharmacological Treatment: Metformin Versus Atorvastatin
NCT01544751
UNKNOWN
NA
A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease
NCT01277094
COMPLETED
PHASE1
Non Alcoholic Fatty Liver Disease Influence of Statin Therapy
NCT00375349
WITHDRAWN
NA
Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation
NCT05256979
ACTIVE_NOT_RECRUITING
A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03350165
COMPLETED
PHASE2
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
NCT04766476
TERMINATED
PHASE1
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
NCT07214870
RECRUITING
PHASE1
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
NCT05364684
COMPLETED
PHASE2
Study in Healthy Adults Evaluating PF-07202954
NCT04857437
COMPLETED
PHASE1
6-week Safety and PD Study in Adults With NAFLD
NCT03256526
COMPLETED
PHASE2
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NCT04849728
RECRUITING
PHASE3
Safety And Efficacy Study Of Orally Administered Epeleuton In Patients With NAFLD
NCT02941549
COMPLETED
PHASE2
Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients
NCT01999101
COMPLETED
PHASE2
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03248882
COMPLETED
PHASE2
A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis
NCT02316717
COMPLETED
PHASE2
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
NCT02548351
TERMINATED
PHASE3
A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease
NCT02927314
COMPLETED
PHASE2
FTIH of ECC4703 in Healthy Volunteers
NCT05552274
COMPLETED
EARLY_PHASE1
Study to Evaluate MET642 in Patients With NASH
NCT04773964
COMPLETED
PHASE2
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
NCT04505436
ACTIVE_NOT_RECRUITING
PHASE2
Fecal Microbiota Transplantation (FMT) in Nonalcoholic Steatohepatitis(NASH). A Pilot Study
NCT02469272
UNKNOWN
PHASE1
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
NCT04006145
COMPLETED
PHASE2
A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction
NCT05478603
COMPLETED
PHASE1