Phase 2
N=101
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
NASH - Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT04328077 ↗Enrolled (actual)
101
Serious AEs
2.0%
Results posted
Jun 2022
Primary outcome: Primary: Number of Participants With Adverse Events for TERN-101 Versus Placebo — 10; 13; 14; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TERN-101 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terns, Inc.
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events for TERN-101 Versus Placebo |
10; 13; 14; 15 | — |
| SECONDARY Percent Change From Baseline in ALT Outcome Measure |
-5.33; -2.63; -17.99; -13.22 | 0.7755 |
| SECONDARY Plasma Concentration of TERN-101 - AUC 0-24 |
1380; 1470; 2510 | — |
| SECONDARY Plasma Concentration of TERN-101 - Cmax |
116; 155; 389 | — |
| SECONDARY Plasma Concentration of TERN-101 - Tmax |
1; 1; 0.5 | — |
| SECONDARY Plasma Concentration of TERN-101 - t1/2 |
14.6; 6.75; 6 | — |
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.
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 PDFF liver fat content ≥ 10 %
- 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
- Total bilirubin > 1.2 mg/dL
- Albumin 1.1
- AST or ALT > 5 x ULN
- ALP > 156 IU/L
- Platelet count 5% within past 3 months prior to Screening
- Uncontrolled diabetes
- Uncontrolled hyperlipidemia
- Active COVID-19 infection
- Other protocol-defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT04328077). 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.