Phase
Condition
Hepatic Fibrosis
Hyponatremia
Treatment
RO7790121
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body mass index within the range of >= 25 and <=45 kilograms per square meter (kg/m^2)
MASH with fibrosis score of F3 or F4 confirmed by transient elastography measurement >=12.0 kPa and <=25.0 kPa
Agreement to adhere to the contraception requirements
Exclusion
Exclusion Criteria:
Weight gain or loss >5% in the 3 months prior to baseline or >10% in the 6 monthsprior to baseline
Bariatric surgery within 1 year prior to baseline
Current signs or prior history of decompensated liver disease
Complications or clinical evidence of portal hypertension
Lack of peripheral venous access
Other causes of liver disease based on medical history and/or centralized review ofliver histology
History of liver transplantation
Current or prior history of hepatocellular carcinoma (HCC)
Uncontrolled hypertension
Concomitant Type 1 diabetes, or Type 2 diabetes with HbA1c >10%
History of malignancy within 5 years prior to screening, with the exception ofmalignancies with a negligible risk of metastasis or death
Current, significant alcohol consumption or a history of significant alcoholconsumption for a period of more than 3 consecutive months any time within 1 yearprior to screening
Initiation of a medication of an antidiabetic, weight loss, lipid-modifying oranti-depressant drug class
Active tuberculosis requiring treatment within the 12 months prior to baseline
History of organ transplant
Study Design
Connect with a study center
FDI Clinicial Research - Mayaguez
Mayagez, 00680
Puerto RicoActive - Recruiting
Fundacion de Investigacion de Diego
San Juan, 00927
Puerto RicoActive - Recruiting
Adobe Clinical Research, LLC
Tucson, Arizona 85712
United StatesActive - Recruiting
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia 30060
United StatesActive - Recruiting
Delta Research Partners, LLC (Bastrop)
Bastrop, Louisiana 71220
United StatesActive - Recruiting
Jubilee Clinical Research, Inc
Las Vegas, Nevada 89106
United StatesActive - Recruiting
Premier Medical Group Int Medcn
Clarksville, Tennessee 37040
United StatesActive - Recruiting
Pinnacle Clinical Research - Austin
Austin, Texas 78757
United StatesActive - Recruiting
Bellaire Clinical Research, LLC
Bellaire, Texas 77401
United StatesActive - Recruiting
DHR Health Institute for Research and Development
Edinburg, Texas 78539
United StatesActive - Recruiting
Pinnacle Clinical Research Georgetown
Georgetown, Texas 78626
United StatesActive - Recruiting
Houston Research Institute
Houston, Texas 77079
United StatesActive - Recruiting
Pinnacle Clinical Research, PLLC
San Antonio, Texas 78229
United StatesActive - Recruiting
GI Alliance
Southlake, Texas 76092
United StatesActive - Recruiting
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