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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
NCT05415722 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Terns, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05415722 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05415722?
The interventions under investigation include: Placebo (OTHER), TERN-501 (DRUG), TERN-101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05415722?
This trial is sponsored by Terns, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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