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NCT06465186 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
A Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT06465186: Active Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Merck Sharp & Dohme.
NCT06465186 is a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 80 participants, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06465186, a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn: * If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver * About the safety of efinopegdutide and how well people tolerate it
Primary Outcome
Researchers will measure the change in the amount of fat in the liver using magnetic resonance imaging (MRI) after about 7 months of treatment. The change in MRI-Estimated proton density fat fraction (PDFF) will be measured from baseline to 28 weeks.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT Efinopegdutide
Study Locations (20)
Arizona
- The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149) - Chandler
- Arizona Clinical Trials ( Site 0158) - Flagstaff
- The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120) - Peoria
- The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111) - Tucson
Florida
- Synergy Healthcare ( Site 0118) - Bradenton
- Homestead Associates in Research, Inc. ( Site 0139) - Homestead
- Florida Research Institute ( Site 0116) - Lakewood Rch
- Floridian Clinical Research, LLC ( Site 0109) - Miami Lakes
California
- California Liver Research Institute ( Site 0113) - Pasadena
- Acclaim Clinical Research ( Site 0137) - San Diego
- Velocity Clinical Research, Panorama City ( Site 0124) - Van Nuys
Louisiana
- Delta Research Partners ( Site 0160) - Bastrop
- Louisiana Research Center ( Site 0161) - Shreveport
Maryland
- Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130) - Glen Burnie
- Velocity Clinical Research Rockville ( Site 0143) - Rockville
Nevada
- The Machuca Foundation ( Site 0115) - Las Vegas
- Excel Clinical Research, LLC ( Site 0101) - Las Vegas
Colorado
- Rocky Mountain Gastroenterology ( Site 0127) - Littleton
Georgia
- Southeast Clinical Research Center ( Site 0119) - Dalton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-07-12 |
| Est. Completion | 2026-08-06 |
| Phase | Phase 2 |
What the registry record for NCT06465186 still lists
NCT06465186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (55% lower).
The record links to 5 conditions, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06465186 names 20 study sites across 9 states, led by Arizona, Florida, California.
Frequently Asked Questions
What is clinical trial NCT06465186 about?
NCT06465186 is a clinical study titled "A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)". Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat...
What is the current status of trial NCT06465186?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-07-12. Estimated completion is 2026-08-06.
What conditions does trial NCT06465186 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, NAFLD, Metabolic Dysfunction Associated Steatotic Liver Disease, Metabolic Dysfunction-associated Steatohepatitis.
What interventions are being tested in trial NCT06465186?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), Efinopegdutide (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06465186?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06465186 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06465186's enrollment target sits among peer trials
80 21st of 57 higher than 36 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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