Stage 1-3 - Non-Cirrhosis NASH Trials
Age – Adult (18+)
Gender – Female, Male
Disease Type – Non-Alcoholic Steatohepatitis
Phase – 3a
Length of Treatment – 4.5 years
Compensation available.
Inclusion:
– Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy
– Histological evidence of fibrosis stage 2 or stage 3
– Males and non-pregnant females
Exclusion:
– Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)
– Presence or history of ascites
– Known or suspected excessive consumption of alcohol or alcohol dependence
NN9931-4553: The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis
https://clinicaltrials.gov/ct2/show/NCT04822181
Age – Adult (18-75)
Gender – Female, Male
Disease Type – Non-Alcoholic Steatohepatitis
Phase – 2a
Length of Treatment – 12-24 weeks
Compensation available.
Inclusion:
– Obese subjects with BMI within the range of 30 to 45 kg/m2
– Consent to liver biopsy
– Males and non-pregnant females
Exclusion:
– Documented clinical, laboratory or radiologic evidence of cirrhosis
– History of pancreatitis
– Subjects with gallstones or biliary sludge and a history of symptoms consistent with biliary disease
– History of bariatric surgery
BOS-580-201: A Phase 2a, randomized, blinded, placebo-controlled study of BOS-580 in obese subjects at risk for, or with biopsy-confirmed, nonalcoholic steatohepatitis (NASH)
Age – Adult (18+)
Gender – Female, Male
Disease Type – Non-Alcoholic Steatohepatitis
Phase – 3
Length of Treatment – 120 weeks
Compensation available.
Inclusion:
– Diagnosis of NASH
– For overweight/obese patient, history of at least 1 unsuccessful attempt to reduce body weight by diet and/or exercise within the past 6 years
– Males and non-pregnant females
Exclusion:
– Documented causes of chronic liver disease other than NASH
– Documented liver cirrhosis in a historical biopsy
– History or current diagnosis of hepatocellular carcinoma (HCC)
– Planned or prior bariatric surgery
Inventiva: A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
Age – Adult (18-75)
Gender – Female, Male
Disease Type – Non-Alcoholic Steatohepatitis
Phase – 2b
Length of Treatment – 52 weeks
Compensation available
Inclusion:
– Carriers for the PNPLA3 rs738409 148M risk allele
– Medication must be stable for participants on GLP1 RA, SGLT2i or pioglitazone
– Males and non-pregnant females
Exclusion:
– History of liver transplant or current placement on a liver transplant list
– Liver disease of other aetiologies
– History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding
– Recent (within 3 months of screening visit) use of drugs approved for weight loss
AstraZeneca: A Randomised, Double-blind, Placebo-controlled, Multi-centre
Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele
Age – Adult (18-75)
Gender – Female, Male
Disease Type – Non-Alcoholic Steatohepatitis
Phase – 2
Length of Treatment – 60 weeks
Compensation available
Inclusion:
– Diagnosis of NASH
– No significant lifestyle changes, including changes in diet, alcohol intake or exercise, for the 3 months prior to study entry
– BMI ≥ 27.0 kg/m2
– Males and non-pregnant females
Exclusion:
– History of cirrhosis or complications of cirrhosis
– Documented causes of chronic liver disease other than NASH
– Obesity induced by underlying disorders including:
a. Known genetic diseases
b. Endocrine disorders
b. Endocrine disorders
– Anti-obesity medications
ALT-801-203: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects with Nonalcoholic Steatohepatitis (NASH)
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Additional Information
For more information on what current clinical trials are available at Kansas City Research Institute or additional information and how to get involved, please contact our office phone at (816)759-2574 or send by email at study@kcresearchinstitute.com.