Phase 1
N=52
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
NASH - Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT04897594 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Patient Incidence of Adverse Events for TERN-201 Versus Placebo — 9; 11; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TERN-201 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terns, Inc.
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Incidence of Adverse Events for TERN-201 Versus Placebo |
9; 11; 8 | — |
| PRIMARY Treatment-Emergent Laboratory Abnormalities |
0; 1; 1; 0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04897594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.