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

Terns Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: TERN-201; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04897594

TERN201-1007

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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 could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

52 participants in 3 patient groups, including a placebo group

TERN-201 10mg

Experimental group

Description:

Orally administered

Treatment:

Drug: TERN-201

TERN-201 20mg

Experimental group

Description:

Orally Administered

Treatment:

Drug: TERN-201

Placebo

Placebo Comparator group

Description:

Orally administered

Treatment:

Other: Placebo