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

Sponsor

Terns, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05415722

Collaborator

(none)

140

Enrollment

Locations

Arms

11.8

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
NASH - Nonalcoholic Steatohepatitis	Drug: TERN-501 Drug: TERN-101 Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a 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)

Actual Study Start Date :

Jul 7, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: TERN-501 1 mg Orally administered.	Drug: TERN-501 Investigational drug
Experimental: Arm 2: TERN-501 3 mg Orally administered.	Drug: TERN-501 Investigational drug
Experimental: Arm 3: TERN-501 6 mg Orally administered.	Drug: TERN-501 Investigational drug
Experimental: Arm 4: TERN-501 3 mg + TERN-101 10 mg Orally administered.	Drug: TERN-501 Investigational drug Drug: TERN-101 Investigational drug
Experimental: Arm 5: TERN-501 6 mg + TERN-101 10 mg Orally administered.	Drug: TERN-501 Investigational drug Drug: TERN-101 Investigational drug
Experimental: Arm 6:TERN-101 10 mg Orally administered.	Drug: TERN-101 Investigational drug
Placebo Comparator: Arm 7: Matching placebo Orally administered.	Other: Placebo Matching placebo

Outcome Measures

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 [12 weeks]

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 [12 weeks]
Relative change from baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo [12 weeks]
Change from baseline in cT1 relaxation time at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo [12 weeks]
Patient incidence of treatment emergent adverse events for all treatment groups [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Male or female, 18 to 75 years of age
Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
Presumed NASH diagnosed by prior biopsy and/or imaging criteria
Written informed consent

Key Exclusion Criteria:

History or clinical evidence of chronic liver diseases other than NAFLD
History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment,
History of liver transplant, or current placement on a liver transplant list
Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy.
Abnormal TSH or free T4 levels
Weight loss of > 5% total body weight within 3 months prior to Screening
Uncontrolled diabetes
Uncontrolled hyperlipidemia
Unstable cardiovascular disease
Excessive alcohol consumption

Other protocol-defined I/E criteria that apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 1003: Clinical Trials of Texas, LLC	San Antonio	Texas	United States	78215
2	Site 1006: American Research Corporation	San Antonio	Texas	United States	78215