Clinical trial NCT04897594: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO)
Nonalcoholic steatohepatitis (NASH)
Nonalcoholic Fatty Liver Disease (NAFLD)
Lead sponsor: Terns, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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 could apply.

Primary outcomes:
measure: Patient Incidence of Adverse Events for TERN-201 Versus Placebo
timeFrame: Day 1 through Week 16
measure: Treatment-Emergent Laboratory Abnormalities
timeFrame: Day 1 through Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Terns Clinical Study Site 1018
state: Arizona
city: Tucson
country: United States
facility: Terns Clinical Study Site 1024
state: Arizona
city: Coronado
country: United States
facility: Terns Clinical Study Site 1004
state: California
city: Los Angeles
country: United States
facility: Terns Clinical Study Site 1039
state: California
city: Panorama City
country: United States
facility: Terns Clinical Study Site 1001
state: California
city: Rialto
country: United States
facility: Terns Clinical Study Site 1040
state: California
city: San Diego
country: United States
facility: Terns Clinical Study Site 1013
state: California
city: Bastrop
country: United States
facility: Terns Clinical Study Site 1010
state: Louisiana
city: San Antonio
country: United States
facility: Terns Clinical Study Site 1006
state: Texas
city: San Antonio
country: United States
facility: Terns Clinical Study Site 1003
state: Texas
city: San Antonio
country: United States
facility: Terns Clinical Study Site 1019
state: Texas
Study officials:
affiliation: Terns, Inc.
name: clinicaltrials@ternspharma.com
role: STUDY_DIRECTOR
References: