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

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TERN-201
Placebo
Sponsored by
Terns, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis focused on measuring Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO), Nonalcoholic steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 that apply

Sites / Locations

  • Terns Clinical Study Site 1018
  • Terns Clinical Study Site 1024
  • Terns Clinical Study Site 1004
  • Terns Clinical Study Site 1039
  • Terns Clinical Study Site 1001
  • Terns Clinical Study Site 1040
  • Terns Clinical Study Site 1013
  • Terns Clinical Study Site 1010
  • Terns Clinical Study Site 1006
  • Terns Clinical Study Site 1003
  • Terns Clinical Study Site 1019

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part 1: TERN-201 dose level 1

Part 1: Placebo

Part 2: TERN-201 dose level 2

Part 2: Placebo

Arm Description

Orally administered.

Orally Administered

Orally administered

Orally administered

Outcomes

Primary Outcome Measures

Subject incidence of adverse events for TERN-201 versus placebo

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2021
Last Updated
September 29, 2022
Sponsor
Terns, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04897594
Brief Title
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Terns, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
Keywords
Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO), Nonalcoholic steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Triple
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: TERN-201 dose level 1
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
Part 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Orally Administered
Arm Title
Part 2: TERN-201 dose level 2
Arm Type
Experimental
Arm Description
Orally administered
Arm Title
Part 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Orally administered
Intervention Type
Drug
Intervention Name(s)
TERN-201
Intervention Description
Investigational drug
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Subject incidence of adverse events for TERN-201 versus placebo
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Plasma concentration of TERN-201- AUC
Description
Area under the curve
Time Frame
12 weeks
Title
Plasma concentration of TERN-201- Cmax
Description
Maximum observed concentration
Time Frame
12 weeks
Title
Plasma concentration of TERN-201- Tmax
Description
Time to reach maximum measured plasma concentration
Time Frame
12 weeks
Title
Plasma concentration of TERN-201- T1/2
Description
Determination of half-life
Time Frame
12 weeks
Title
Percent Change from baseline in plasma VAP-1/SSAO activity
Time Frame
12 weeks
Title
Urine concentration of TERN-201- CLr
Description
Renal clearance
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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 that apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
clinicaltrials@ternspharma.com
Organizational Affiliation
Terns, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Terns Clinical Study Site 1018
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Terns Clinical Study Site 1024
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Terns Clinical Study Site 1004
City
Coronado
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Terns Clinical Study Site 1039
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Terns Clinical Study Site 1001
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Terns Clinical Study Site 1040
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Terns Clinical Study Site 1013
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Terns Clinical Study Site 1010
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Terns Clinical Study Site 1006
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Terns Clinical Study Site 1003
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Terns Clinical Study Site 1019
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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