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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

Phase 2
Waitlist Available
Research Sponsored by Terns, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing a new drug called TERN-501, alone or with TERN-101, in adults with a liver condition called NASH that isn't caused by alcohol and doesn't involve severe scarring. The study will see if the drug is safe, effective, and how it behaves in the body.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 6:TERN-101 10 mgExperimental Treatment1 Intervention
Orally administered.
Group II: Arm 5: TERN-501 6 mg + TERN-101 10 mgExperimental Treatment2 Interventions
Orally administered.
Group III: Arm 4: TERN-501 3 mg + TERN-101 10 mgExperimental Treatment2 Interventions
Orally administered.
Group IV: Arm 3: TERN-501 6 mgExperimental Treatment1 Intervention
Orally administered.
Group V: Arm 2: TERN-501 3 mgExperimental Treatment1 Intervention
Orally administered.
Group VI: Arm 1: TERN-501 1 mgExperimental Treatment1 Intervention
Orally administered.
Group VII: Arm 7: Matching placeboPlacebo Group1 Intervention
Orally administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TERN-501
2022
Completed Phase 2
~170
TERN-101
2022
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

Terns, Inc.Lead Sponsor
3 Previous Clinical Trials
233 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
153 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Study DirectorStudy DirectorTerns, Inc.
1,290 Previous Clinical Trials
502,350 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
281 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~47 spots leftby Dec 2025
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