Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study of NASH - Nonalcoholic Steatohepatitis that has completed, run by Terns. The registered enrollment target is 162 participants, below the 263-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 6 states.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05415722
The ClinicalTrials.gov registry entry for NCT05415722 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 263-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (38% lower). The listed sponsor is Terns, which has 5 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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
Similar trials for NASH - Nonalcoholic Steatohepatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
ACTIVE NOT RECRUITING · Phase 2
-
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
ACTIVE NOT RECRUITING · Phase 2
-
Statins for the Treatment of NASH
ACTIVE NOT RECRUITING · Phase 2
-
Tocotrienol Against the Progression of End Stage Liver Disease
ACTIVE NOT RECRUITING · Phase 2
-
Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers
COMPLETED · Phase 2
-
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.