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

A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

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.

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Other: Placebo; Drug: TERN-201

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Terns Clinical Study Site 1018
    • Tucson, Arizona, United States, 85712
      • Terns Clinical Study Site 1024
  • California
    • Coronado, California, United States, 92117
      • Terns Clinical Study Site 1004
    • Los Angeles, California, United States, 90048
      • Terns Clinical Study Site 1039
    • Panorama City, California, United States, 91402
      • Terns Clinical Study Site 1001
    • Rialto, California, United States, 92377
      • Terns Clinical Study Site 1040
    • San Diego, California, United States, 92093
      • Terns Clinical Study Site 1013
  • Louisiana
    • Bastrop, Louisiana, United States, 71220
      • Terns Clinical Study Site 1010
  • Texas
    • San Antonio, Texas, United States, 78215
      • Terns Clinical Study Site 1006
    • San Antonio, Texas, United States, 78229
      • Terns Clinical Study Site 1003
    • San Antonio, Texas, United States, 78229
      • Terns Clinical Study Site 1019

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TERN-201 10mg; Orally administered	Drug: TERN-201; Investigational drug
Experimental: TERN-201 20mg; Orally Administered	Drug: TERN-201; Investigational drug
Placebo Comparator: Placebo; Orally administered	Other: Placebo; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Incidence of Adverse Events for TERN-201 Versus Placebo	Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.	Day 1 through Week 16
Treatment-Emergent Laboratory Abnormalities	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	Day 1 through Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of TERN-201- AUC	Area under the curve	12 weeks
Plasma concentration of TERN-201- Cmax	Maximum observed concentration	12 weeks
Plasma concentration of TERN-201- Tmax	Time to reach maximum measured plasma concentration	12 weeks
Plasma concentration of TERN-201- T1/2	Determination of half-life	12 weeks
Percent Change from baseline in plasma VAP-1/SSAO activity		12 weeks
Urine concentration of TERN-201- CLr	Renal clearance	Day 1

Collaborators and Investigators

• Sponsor: Terns, Inc.
• Investigators: Study Director: clinicaltrials@ternspharma.com, Terns, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Nonalcoholic steatohepatitis (NASH); Nonalcoholic Fatty Liver Disease (NAFLD); Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO)
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: TERN201-1007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No