Clinical trials: Steatosis
NASH - Nonalcoholic Steatohepatitis
Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \& F≥2 from those without.
- Trial name
- NCT04054310
- Testing
- Liver Multi Scan
- Where
- 7 sites in United States
- Volunteers
- 225 people
- Sponsor
- Perspectum
MASH, NASH
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression…
- Conditions
- MASH, NASH, Metabolic Dysfunction-associated Steatohepatitis, Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis
- Trial name
- FASCINATE-3 (NCT06594523)
- Testing
- Denifanstat
- Sponsor
- Sagimet Biosciences Inc.
Non-alcoholic Fatty Liver Disease
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and…
- Trial name
- ZENITH-1 (NCT07221227)
- Testing
- Efimosfermin alfa
- Where
- 91 sites in United States, Australia and 7 more
- Volunteers
- 1,200 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3
Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)
This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH.
- Conditions
- Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3, Metabolic Dysfunction-Associated Steatohepatitis
- Trial name
- MASH (NCT06939816)
- Testing
- Vonafexor low dose, Vonafexor high dose
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Enyo Pharma
Non Alcoholic Steatohepatitis (NASH)
A Phase 2b Study of Icosabutate in Fatty Liver Disease
A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis
- Trial name
- ICONA (NCT04052516)
- Testing
- Icosabutate
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 280 people
- Sponsor
- NorthSea Therapeutics B.V.
NAFLD
A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD
This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD
- Trial name
- NCT03744182
- Testing
- HM15211
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Non-alcoholic Fatty Liver Disease
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry
This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry.
- Trial name
- NCT07335198
- Testing
- Efimosfermin alfa
- Where
- New Zealand
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Liver Fat, Liver Fibrosis
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease…
- Conditions
- Liver Fat, Liver Fibrosis, Glycemic Control, Body Weight Changes
- Trial name
- Ertu-NASH (NCT05644717)
- Testing
- Ertugliflozin 5 mg, 15mg
- Where
- Pakistan
- Volunteers
- 164 people
- Sponsor
- Getz Pharma
NAFLD
Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a randomized, single blind study to determine whether AXA1125 or AXA1957, novel compositions of amino acids, are safe and well tolerated.
- Trial name
- NCT04073368
- Testing
- AXA1957, AXA1125
- Where
- 18 sites in United States
- Volunteers
- 112 people
- Sponsor
- Axcella Health, Inc
Non-alcoholic Steatohepatitis
Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)
This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH).
- Trial name
- NCT05016882
- Testing
- NNC0194 0499 50 mg/mL, Semaglutide 3 mg/mL, NNC0174 0833 10 mg/mL
- Where
- 255 sites in United States, Australia and 22 more
- Volunteers
- 698 people
- Sponsor
- Novo Nordisk A/S
Healthy
Study to Estimate How Common it is to Have Genetic Variants Associated With NAFLD
The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD.
- Trial name
- NCT04494360
- Testing
- No intervention
- Where
- 3 sites in United States
- Volunteers
- 830 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Nonalcoholic Steatohepatitis
A Study to See if Low Level Laser Light Therapy (LLLT) Can Improve the Condition of Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia VERJU and EVRL laser devices is effective in reducing aminoalanine transaminase (ALT) levels in individuals with nonalcoholic…
- Trial name
- NCT03163810
- Testing
- Erchonia Verju Laser, Erchonia EVRL Laser
- Where
- United States
- Sponsor
- Erchonia Corporation
Obesity, Gastric Bypass
Impact of a Specific Micronutrient-probiotic-supplement on Fatty Liver of Patients After Mini-Gastric Bypass Surgery
Aim of this prospective randomized intervention study is to evaluate the effect of a dietary intervention with a specific micronutrient-probiotic-combination for 12 weeks on fatty liver and cardiometabolic status in obese…
- Conditions
- Obesity, Gastric Bypass, NAFLD
- Trial name
- FMG-01 (NCT03585413)
- Testing
- Micronutrient-probiotic-combination
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Bonn Education Association for Dietetics r.A., Cologne, Germany
Diabetes Mellitus, Type 2, Hypertriglyceridemia
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
The design of the Phase 2 clinical trial includes the following elements: Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs.
- Conditions
- Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-Alcoholic Fatty Liver Disease
- Trial name
- NCT05464784
- Testing
- MN-001
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- MediciNova
Liver Cirrhosis
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
This study is open to adults with a type of confirmed liver condition called compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- Trial name
- NCT07325526
- Testing
- BI 3802876
- Where
- 27 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Boehringer Ingelheim
NON-ALCOHOLIC STEATOHEPATITIS
Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH
A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA 1241 in subjects with presumed non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT06054815
- Testing
- DA-1241, Sitagliptin
- Where
- 18 sites in United States
- Volunteers
- 109 people
- Sponsor
- NeuroBo Pharmaceuticals Inc.
Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NCT05462353
- Testing
- 2mg of ASC41, 4mg of ASC41 (2 tablets of 2 mg ASC41)
- Where
- China
- Volunteers
- 183 people
- Sponsor
- Gannex Pharma Co., Ltd.
Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Study of VV-14303 for the Treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Study of VV-14303 for the Treatment of Metabolic dysfunction-associated steatohepatitis (MASH)
- Trial name
- RESTORE (NCT07732400)
- Testing
- VV-14303
- Where
- 3 sites in United States, New Zealand
- Volunteers
- 56 people
- Sponsor
- Kriya Therapeutics, Inc.
Non-alcoholic Steatohepatitis NASH
Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH
The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH
- Trial name
- NCT02913105
- Testing
- LMB763
- Where
- 30 sites in United States, Australia and 6 more
- Volunteers
- 122 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers, Hepatic Steatosis
Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation).
- Trial name
- NCT06891365
- Testing
- NNC0581-0001
- Where
- United Kingdom
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S