TERN-501 for Nonalcoholic Steatohepatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Terns Clinical Study Site 1006, San Antonio, TX
Nonalcoholic Steatohepatitis+2 More
TERN-501 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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)

Eligible Conditions

  • Nonalcoholic Steatohepatitis
  • Non Alcoholic Steatohepatitis (NASH)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Nonalcoholic Steatohepatitis

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 16 weeks

12 weeks
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
Relative change from baseline in MRI-PDFF at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo
Relative change from baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo
16 weeks
Patient incidence of treatment emergent adverse events for all treatment groups

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Nonalcoholic Steatohepatitis

Trial Design

7 Treatment Groups

Arm 4: TERN-501 3 mg + TERN-101 10 mg
1 of 7
Arm 5: TERN-501 6 mg + TERN-101 10 mg
1 of 7
Arm 3: TERN-501 6 mg
1 of 7
Arm 1: TERN-501 1 mg
1 of 7
Arm 6:TERN-101 10 mg
1 of 7
Arm 2: TERN-501 3 mg
1 of 7
Arm 7: Matching placebo
1 of 7
Experimental Treatment
Non-Treatment Group

140 Total Participants · 7 Treatment Groups

Primary Treatment: TERN-501 · Has Placebo Group · Phase 2

Arm 4: TERN-501 3 mg + TERN-101 10 mgExperimental Group · 2 Interventions: TERN-501, TERN-101 · Intervention Types: Drug, Drug
Arm 5: TERN-501 6 mg + TERN-101 10 mgExperimental Group · 2 Interventions: TERN-501, TERN-101 · Intervention Types: Drug, Drug
Arm 3: TERN-501 6 mg
Drug
Experimental Group · 1 Intervention: TERN-501 · Intervention Types: Drug
Arm 1: TERN-501 1 mg
Drug
Experimental Group · 1 Intervention: TERN-501 · Intervention Types: Drug
Arm 6:TERN-101 10 mg
Drug
Experimental Group · 1 Intervention: TERN-101 · Intervention Types: Drug
Arm 2: TERN-501 3 mg
Drug
Experimental Group · 1 Intervention: TERN-501 · Intervention Types: Drug
Arm 7: Matching placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TERN-101
2020
Completed Phase 2
~110

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
Closest Location: Terns Clinical Study Site 1006 · San Antonio, TX
Photo of San Antonio  1Photo of San Antonio  2Photo of San Antonio  3
2021First Recorded Clinical Trial
0 TrialsResearching Nonalcoholic Steatohepatitis
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18 and 75 years.
You are overweight or obese with a BMI ≥ 25 kg/m2.
You have a prior diagnosis of NASH.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.