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TERN-501 for Non-alcoholic Fatty Liver Disease

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 16 weeks

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of TERN-501 as a possible treatment for non-alcoholic steatohepatitis (NASH).

Eligible Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relative change from baseline in MRI-PDFF at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo

Secondary outcome measures

Change from baseline in cT1 relaxation time at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo

Change from baseline in cT1 relaxation time at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo

Patient incidence of treatment emergent adverse events for all treatment groups

+1 more

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

Do I qualify?Apply below to find out

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.

1,207 Previous Clinical Trials

489,518 Total Patients Enrolled

2 Trials studying Non-alcoholic Fatty Liver Disease

281 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this scientific investigation?

"The requirements to be a part of this trial include nonalcoholic steatohepatitis and an age between 18-75 years old. This research is seeking approximately 140 volunteers for the study."

Answered by AI

Has TERN-501 been officially sanctioned by the Food and Drug Administration?

"Considering the scant evidence for efficacy, TERN-501 was rated a 2 on our safety scale. However, there is some data confirming its relative security."

Answered by AI

How many participants are participating in this experiment?

"In order to complete the trial, 140 qualified individuals are needed. These participants can take part at Site 1051: South Texas Research Institute in Edinburg, Texas and/or Site 1005 in Arlington Iowa."

Answered by AI

Is the trial open to applicants aged 55 and above?

"This trial allows patients aged 18 and above, up to a maximum of 75 years old, as per the inclusion criteria guidelines."

Answered by AI

How many sites are overseeing this research endeavor?

"The trial is available in 15 locations, including the South Texas Research Institute of Edinburg, Pinnacle Clinical Research in Austin, and a centre at Arlington. Additionally there are 12 other sites where this clinical study can be accessed."

Answered by AI

Is there still capacity for other participants to join this trial?

"According to the details on clinicaltrials.gov, this study is now seeking participants with a start date of July 7th 2022 and an update date of September 29th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05415722.