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)
Overview
- Phase
- Phase 2
- Intervention
- TERN-501
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Sponsor
- Terns, Inc.
- Enrollment
- 162
- Locations
- 35
- Primary Endpoint
- Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.
- Status
- Completed
- Last Updated
- last year
Overview
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)
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Arm 1: TERN-501 1 mg
Orally administered.
Intervention: TERN-501
Arm 2: TERN-501 3 mg
Orally administered.
Intervention: TERN-501
Arm 3: TERN-501 6 mg
Orally administered.
Intervention: TERN-501
Arm 4: TERN-501 3 mg + TERN-101 10 mg
Orally administered.
Intervention: TERN-501
Arm 4: TERN-501 3 mg + TERN-101 10 mg
Orally administered.
Intervention: TERN-101
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
Intervention: TERN-501
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
Intervention: TERN-101
Arm 6:TERN-101 10 mg
Orally administered.
Intervention: TERN-101
Arm 7: Matching placebo
Orally administered.
Intervention: Placebo
Outcomes
Primary Outcomes
Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.
Time Frame: 12 weeks
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x \[(Week 12 Value - Baseline Value)/Baseline Value\].
Secondary Outcomes
- 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)
- Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%)(16 weeks)