The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of cotadutide at 300 and 600 μg in participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Cotadutide administered subcutaneously once daily
Placebo administered subcutaneously once daily
Number of Participants With Adverse Events (AEs).
To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Participants With Abnormal Vital Signs.
To assess safety and tolerability of Cotadutide.
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Participants With Abnormal Laboratory Assessments
To assess safety and tolerability of Cotadutide.
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG).
To assess safety and tolerability of Cotadutide.
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Treatment-induced Anti-Drug Antibody (ADA) Participants
To assess the immunogenicity of Cotadutide
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Titer of Treatment-induced Anti-Drug Antibody (ADA)
To assess the immunogenicity of cotadutide. Titers represent a dilution and are therefore unitless. Summary statistics are based on the maximum observed titer for each ADA positive subject within the time frame.
Time frame: From first dose on Day 1 until the follow-up period, 28 days post last dose (from randomization up to approximately 52 weeks).
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Research Site
Tucson, Arizona, United States
Research Site
Canoga Park, California, United States
Research Site
Gilroy, California, United States
Research Site
Sacramento, California, United States
Research Site
Englewood, Colorado, United States
Research Site
Bradenton, Florida, United States
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Homestead, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
...and 105 more locations