Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT03823703
Last Updated: 2022-08-31
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2020-11-04
2021-04-05
Brief Summary
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Detailed Description
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Due to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Miricorilant- 900 mg
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
Miricorilant
Tablets taken orally
Miricorilant- 600 mg
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
Miricorilant
Tablets taken orally
Placebo
Placebo tablets
Placebo
Participants received 6 placebo tablets orally once daily.
Placebo
Placebo tablets
Interventions
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Miricorilant
Tablets taken orally
Placebo
Placebo tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of presumed NASH based on blood tests and scans
Exclusion Criteria
* Have participated in another clinical trial for any other indication within the last 3 months
* Are pregnant or lactating women
* Have a BMI \<18 kg/m\^2
* Have had liver transplantation or plan to have liver transplantation during the study
* Have type 1 diabetes or poorly controlled type 2 diabetes.
18 Years
75 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Director
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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Site 207
Chandler, Arizona, United States
Site 208
Glendale, Arizona, United States
Site 209
Tucson, Arizona, United States
Site 227
Los Angeles, California, United States
Site 214
Panorama City, California, United States
Site 233
Santa Ana, California, United States
Site 234
Port Orange, Florida, United States
Site 210
Sarasota, Florida, United States
Site 228
Kansas City, Missouri, United States
Site 232
East Syracuse, New York, United States
Site 211
Austin, Texas, United States
Site 213
Edinburg, Texas, United States
Site 215
Edinburg, Texas, United States
Site 212
San Antonio, Texas, United States
Site 226
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CORT118335-860
Identifier Type: -
Identifier Source: org_study_id
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