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NCT05415722 · ClinicalTrials.gov registry record · Phase 2
DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis
A Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Terns.
- Completed
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
- 20
- Study locations
NCT05415722: Completed Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Terns.
NCT05415722 is a Phase 2 study of NASH - Nonalcoholic Steatohepatitis that has completed, run by Terns. The registered enrollment target is 162 participants, below the 256-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05415722, a Phase 2 study of NASH - Nonalcoholic Steatohepatitis, has completed, sponsored by Terns.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)
Primary Outcome
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x \[(Week 12 Value - Baseline Value)/Baseline Value\].
Conditions Studied
Interventions
- OTHER Placebo
- DRUG TERN-501
- DRUG TERN-101
Study Locations (20)
Florida
- Site 1062 Excel Medical Clinical Trials, LLC - Boca Raton
- Site 1057:Integrity Clinical Research, LLC - Doral
- Site 1041: Florida Research Institute - Lakewood Rch
- Site 1058 Optimus U Corporation - Miami
- Site 1036 Schiff Center for Liver Diseases / University of Miami - Miami
- Site 1045 University of Miami Hospital & Clinics, Sylvester Comp. Cancer Center - Miami
- Site 1007: Floridian Clinical Research, LLC - Miami Lakes
- Site 1055: Progressive Medical Research - Port Orange
California
- Site 1004 Southern California Research Center - Coronado
- Site 1061 Velocity Clinical Research, Gardena - Gardena
- Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute - La Jolla
- Site 1016 Ruane Clinical Research Group Inc. - Los Angeles
- Site 1060 Catalina Research Institute, LLC - Montclair
- Site 1001 National Research Institute - Panorama City
- Site 1040 Inland Empire Clinical Trials, LLC - Rialto
Arizona
- Site 1017: The Institute for Liver Health dba Arizona Liver Health - Chandler
- Site 1018: Arizona Liver Health - Tucson
Indiana
- Site 1032 IU Health University Hospital - Indianapolis
Iowa
- Site 1052: Iowa Diabetes and Endocrinology Research Center - West Des Moines
Louisiana
- Site 1054 Louisiana Research Center - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2023-07-10 |
| Phase | Phase 2 |
What the finished NCT05415722 record still lists
NCT05415722 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 256-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (37% lower).
The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05415722 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05415722 about?
NCT05415722 is a clinical study titled "DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis". This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcohol...
What is the current status of trial NCT05415722?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2022-06-28. Estimated completion is 2023-07-10.
What conditions does trial NCT05415722 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT05415722?
The interventions under investigation include: Placebo (OTHER), TERN-501 (DRUG), TERN-101 (DRUG).
Who is sponsoring clinical trial NCT05415722?
This trial is sponsored by Terns, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05415722 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05415722's enrollment target sits among peer trials
162 12th of 28 higher than 17 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis 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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