LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

NCT04328077 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TERN101-2001
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 31

Brief Summary

This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

Farnesoid X receptor; NASH; Nonalcoholic Steatohepatitis; NAFLD; Nonalcoholic Fatty Liver Disease; FXR

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events for TERN-101 Versus Placebo

  16 weeks

Secondary Outcomes (5)

• Percent Change From Baseline in ALT Outcome Measure

  12 weeks

• Plasma Concentration of TERN-101 - AUC 0-24

  12 weeks (0-24 hours post dose)

• Plasma Concentration of TERN-101 - Cmax

  12 Weeks (0-72 hours post dose)

• Plasma Concentration of TERN-101 - Tmax

  12 Weeks (0-72 hours post dose)

• Plasma Concentration of TERN-101 - t1/2

  12 Weeks (0-72 hours post dose)

Study Arms (4)

TERN-101 dose level 1

EXPERIMENTAL

Orally administered.

Drug: TERN-101

TERN-101 dose level 2

EXPERIMENTAL

Orally administered.

Drug: TERN-101

TERN-101 dose level 3

EXPERIMENTAL

Orally administered.

Drug: TERN-101

Placebo

PLACEBO COMPARATOR

Orally administered.

Other: Placebo

Interventions

TERN-101 DRUG

Investigational drug

TERN-101 dose level 1; TERN-101 dose level 2; TERN-101 dose level 3

Placebo OTHER

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 PDFF liver fat content ≥ 10 %
• Written informed consent

You may not qualify if:

• 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
• Total bilirubin \> 1.2 mg/dL
• Albumin \< 3.5 g/dL
• INR \> 1.1
• AST or ALT \> 5 x ULN
• ALP \> 156 IU/L
• Platelet count \< 150,000 /mm3
• eGFR \< 60 mL/min/1.73m2
• Weight loss \> 5% within past 3 months prior to Screening
• Uncontrolled diabetes
• Uncontrolled hyperlipidemia
• Active COVID-19 infection

Sponsors & Collaborators

• Terns, Inc.: lead

Study Sites (31)

Terns Clinical Study Site 1017

Chandler, Arizona, 85224, United States

Location

Terns Clinical Study Site 1018

Tucson, Arizona, 85712, United States

Location

Terns Clinical Study Site 1024

Tucson, Arizona, 85712, United States

Location

Terns Clinical Study Site 1004

Coronado, California, 92117, United States

Location

Terns Clinical Study Site 1035

Fresno, California, 93720, United States

Location

Terns Clinical Study Site 1013

La Jolla, California, 92037, United States

Location

Terns Clinical Study Site 1016

Los Angeles, California, 90036, United States

Location

Terns Clinical Study Site 1008

Montclair, California, 91763, United States

Location

Terns Clinical Study Site 1001

Panorama City, California, 91402, United States

Location

Terns Clinical Study Site 1012

Gainesville, Florida, 32610, United States

Location

Terns Clinical Study Site 1007

Hialeah, Florida, 33013, United States

Location

Terns Clinical Study Site 1028

Hialeah, Florida, 33014, United States

Location

Terns Clinical Study Site 1009

Miami, Florida, 33166, United States

Location

Terns Clinical Study Site 1033

Orlando, Florida, 32806, United States

Location

Terns Clinical Study Site 1032

Indianapolis, Indiana, 46202, United States

Location

Terns Clinical Study Site 1010

Bastrop, Louisiana, 71220, United States

Location

Terns Clinical Study Site 1037

New Orleans, Louisiana, 70121, United States

Location

Terns Clinical Study Site 1023

Shreveport, Louisiana, 71105, United States

Location

Terns Clinical Study Site 1002

Baltimore, Maryland, 21202, United States

Location

Terns Clinical Study Site 1011

Boston, Massachusetts, 02118, United States

Location

Terns Clinical Study Site 1038

Florham Park, New Jersey, 07932, United States

Location

Terns Clinical Study Site 1027

Durham, North Carolina, 27710, United States

Location

Terns Clinical Study Site 1014

Hermitage, Tennessee, 37076, United States

Location

Terns Clinical Study Site 1005

Arlington, Texas, 76012, United States

Location

Terns Clinical Study Site 1025

Georgetown, Texas, 78628, United States

Location

Terns Clinical Study Site 1021

Houston, Texas, 77030, United States

Location

Terns Clinical Study Site 1029

Houston, Texas, 77030, United States

Location

Terns Clinical Study Site 1006

San Antonio, Texas, 78215, United States

Location

Terns Clinical Study Site 1003

San Antonio, Texas, 78229, United States

Location

Terns Clinical Study Site 1019

San Antonio, Texas, 78229, United States

Location

Terns Clinical Study Site 1022

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Terns, Inc.

clinicaltrials@ternspharma.com

+1 650-525-5535

Study Officials

• clinicaltrials@ternspharma.com

  Terns, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 31, 2020
• Study Start: June 18, 2020
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: August 9, 2022
• Results First Posted: June 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)