AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis

Phase 1

Completed

• Conditions: NASH - Nonalcoholic Steatohepatitis
• Interventions: Drug: TERN-201; Other: Placebo

• Registration Number: NCT04897594
• Lead Sponsor: Terns, Inc.

Brief Summary

This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Study Start: 2021-05-20
• Study First Posted: 2021-05-21
• Primary Completion: 2022-09-02
• Study Completion: 2022-09-02
• Status Verified: 2023-12
• Results First Submitted: 2023-12-21
• Results First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Results First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 based on clinical characteristics or prior liver biopsy
• ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
• MRI-cT1 value> 800 ms
• Written informed consent

Exclusion Criteria

• History or clinical evidence of chronic liver diseases other than NAFLD
• History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
• History of liver transplant, or current placement on a liver transplant list
• Weight loss of > 5% total body weight within 3 months prior to Screening

Note: Other protocol-defined inclusion/exclusion criteria could apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
TERN-201 10mg	TERN-201	Orally administered
Placebo	Placebo	Orally administered
TERN-201 20mg	TERN-201	Orally Administered

Primary Outcome Measures

Name	Time	Method
Treatment-Emergent Laboratory Abnormalities	Day 1 through Week 16	Number of patients with any worsening of ≥ 2 NCI CTCAE Grades in each laboratory assessment category.; CTCAE = Common Terminology Criteria for Adverse Events; NCI = National Cancer Institute; laboratory abnormalities were classified according to NCI CTCAE, version 5, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening
Patient Incidence of Adverse Events for TERN-201 Versus Placebo	Day 1 through Week 16	Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.

Trial Locations

Locations (11)

Terns Clinical Study Site 1018; 🇺🇸 Tucson, Arizona, United States

Terns Clinical Study Site 1024; 🇺🇸 Tucson, Arizona, United States

Terns Clinical Study Site 1001; 🇺🇸 Panorama City, California, United States

Terns Clinical Study Site 1004; 🇺🇸 Coronado, California, United States

Terns Clinical Study Site 1010; 🇺🇸 Bastrop, Louisiana, United States

Terns Clinical Study Site 1040; 🇺🇸 Rialto, California, United States

Terns Clinical Study Site 1039; 🇺🇸 Los Angeles, California, United States

Terns Clinical Study Site 1013; 🇺🇸 San Diego, California, United States

Terns Clinical Study Site 1003; 🇺🇸 San Antonio, Texas, United States

Terns Clinical Study Site 1019; 🇺🇸 San Antonio, Texas, United States

Terns Clinical Study Site 1006; 🇺🇸 San Antonio, Texas, United States