Phase
Condition
Hyponatremia
Hepatic Fibrosis
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
CIMAB S.A. de C.V.
Torreon, Coahuila 27000
MexicoSite Not Available
CIMAB S.A. de C.V.
Torreón 3981254, Coahuila 4013674 27000
MexicoSite Not Available
Centro de Investigacion Clinica y Medicina Traslacional CIMeT
Guadalajara, Jalisco 44340
MexicoSite Not Available
Hospital General de Occidente SSJ
Zapopan, Jalisco 45170
MexicoSite Not Available
Centro de Investigacion Clinica y Medicina Traslacional CIMeT
Guadalajara 4005539, Jalisco 4004156 44340
MexicoSite Not Available
Hospital General de Occidente SSJ
Zapopan 3979770, Jalisco 4004156 45170
MexicoSite Not Available
Inovacion y Desarrollo en ciencias de la salud
Ciudad De Mxico, Mexico CITY (federal District) 14090
MexicoSite Not Available
Centro de Investigacion y Gastroenterologia
Mexico City, Mexico CITY (federal District) 06700
MexicoSite Not Available
Centro de Investigacion y Gastroenterologia
Mexico City 3530597, Mexico CITY (federal District) 06700
MexicoSite Not Available
Clínica de Enfermedades Crónicas y de Procedimientos Especiales, S.C (CECYPE)
Morelia 3995402, Michoacán 3995955 58249
MexicoSite Not Available
Centro Médico Zambrano Hellion
San Pedro Garza Garcia, Nuevo LEON 66278
MexicoSite Not Available
Fundacion Santos Y De La Garza Evia IBP
San Pedro Garza García, Nuevo León 66278
MexicoSite Not Available
Centro Médico Zambrano Hellion
San Pedro Garza García 4005937, Nuevo León 3522542 66278
MexicoSite Not Available
Fundacion Santos Y De La Garza Evia IBP
San Pedro Garza García 4005937, Nuevo León 3522542 66278
MexicoSite Not Available
Mediadvance Clinical SAPI De CV
Chihuahua, 31203
MexicoSite Not Available
Mediadvance Clinical SAPI De CV
Chihuahua City 4014338, 31203
MexicoSite Not Available
FDI Clinicial Research - Mayaguez
Mayagez, 00680
Puerto RicoSite Not Available
Fundacion de Investigacion de Diego
San Juan, 00927
Puerto RicoSite Not Available
Fundacion de Investigacion de Diego
San Juan 4568127, 00927
Puerto RicoSite Not Available
Adobe Clinical Research, LLC
Tucson, Arizona 85712
United StatesSite Not Available
Adobe Clinical Research, LLC
Tucson 5318313, Arizona 5551752 85712
United StatesSite Not Available
Gastro Health Research - Miami
Miami 4164138, Florida 4155751 33176
United StatesSite Not Available
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia 30060
United StatesSite Not Available
Gastrointestinal Specialists of Georgia, PC
Marietta 4207783, Georgia 4197000 30060
United StatesSite Not Available
Delta Research Partners, LLC (Bastrop)
Bastrop, Louisiana 71220
United StatesSite Not Available
Delta Research Partners, LLC (Bastrop)
Bastrop 4315535, Louisiana 4331987 71220
United StatesSite Not Available
Jubilee Clinical Research NV, LLC
Las Vegas, Nevada 89106
United StatesSite Not Available
Jubilee Clinical Research, Inc
Las Vegas, Nevada 89106
United StatesSite Not Available
Jubilee Clinical Research NV, LLC
Las Vegas 5506956, Nevada 5509151 89106
United StatesSite Not Available
Jubilee Clinical Research, Inc
Las Vegas 5506956, Nevada 5509151 89106
United StatesSite Not Available
Innovative Clinical Research
Clarksville, Tennessee 37040
United StatesSite Not Available
Premier Medical Group Int Medcn
Clarksville, Tennessee 37040
United StatesSite Not Available
Innovative Clinical Research
Clarksville 4613868, Tennessee 4662168 37040
United StatesSite Not Available
Premier Medical Group Int Medcn
Clarksville 4613868, Tennessee 4662168 37040
United StatesSite Not Available
Gastroenterology Center of the MidSouth PC
Cordova 4050552, Tennessee 4662168 38018
United StatesSite Not Available
Pinnacle Clinical Research - Austin
Austin, Texas 78757
United StatesSite Not Available
Bellaire Clinical Research, LLC
Bellaire, Texas 77401
United StatesSite Not Available
DHR Health Institute for Research and Development
Edinburg, Texas 78539
United StatesSite Not Available
Pinnacle Clinical Research Georgetown
Georgetown, Texas 78626
United StatesSite Not Available
Houston Research Institute
Houston, Texas 77079
United StatesSite Not Available
Pinnacle Clinical Research, PLLC
San Antonio, Texas 78229
United StatesSite Not Available
GI Alliance
Southlake, Texas 76092
United StatesSite Not Available
Pinnacle Clinical Research - Austin
Austin 4671654, Texas 4736286 78757
United StatesSite Not Available
Bellaire Clinical Research, LLC
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
DHR Health Institute for Research and Development
Edinburg 4688275, Texas 4736286 78539
United StatesSite Not Available
Pinnacle Clinical Research Georgetown
Georgetown 4693342, Texas 4736286 78626
United StatesSite Not Available
Houston Research Institute
Houston 4699066, Texas 4736286 77079
United StatesSite Not Available
Pinnacle Clinical Research, PLLC
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
GI Alliance
Southlake 4733313, Texas 4736286 76092
United StatesSite Not Available
GI Alliance
Bellevue, Washington 98004
United StatesSite Not Available
GI Alliance
Bellevue 5786882, Washington 5815135 98004
United StatesSite Not Available

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