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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04328077
Enrollment
101
Registered
2020-03-31
Start date
2020-06-18
Completion date
2021-05-19
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

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

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.

Interventions

DRUGTERN-101

Investigational drug

OTHERPlacebo

Matching placebo

Sponsors

Terns, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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 \< 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 * Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
Number of Participants With Adverse Events for TERN-101 Versus Placebo16 weeks

Secondary

MeasureTime frameDescription
Percent Change From Baseline in ALT Outcome Measure12 weeks—
Plasma Concentration of TERN-101 - AUC 0-2412 weeks (0-24 hours post dose)Area under the curve
Plasma Concentration of TERN-101 - Cmax12 Weeks (0-72 hours post dose)Maximum observed concentration
Plasma Concentration of TERN-101 - Tmax12 Weeks (0-72 hours post dose)Time to reach maximum measured plasma concentration
Plasma Concentration of TERN-101 - t1/212 Weeks (0-72 hours post dose)Determination of half-life

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
Placebo Comparator: Placebo: Orally administered
26
TERN-101 5mg
Experimental: TERN-101 dose level 1: Orally administered
25
TERN-101 10mg
Experimental: TERN-101 dose level 2: Orally administered
26
TERN-101 15mg
Experimental: TERN-101 dose level 3: Orally administered
23
Total100

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up0100
Overall StudyWithdrawal by Subject0113

Baseline characteristics

CharacteristicPlaceboTERN-101 5mgTERN-101 10mgTERN-101 15mgTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants3 Participants2 Participants6 Participants
Age, Categorical
Between 18 and 65 years
26 Participants24 Participants23 Participants21 Participants94 Participants
Age, Continuous50.4 years
STANDARD_DEVIATION 11
48.0 years
STANDARD_DEVIATION 12.32
52.5 years
STANDARD_DEVIATION 13.64
51.6 years
STANDARD_DEVIATION 9.49
50.6 years
STANDARD_DEVIATION 11.71
ALT55.51 U/L
STANDARD_DEVIATION 23.639
56.25 U/L
STANDARD_DEVIATION 16.266
60.84 U/L
STANDARD_DEVIATION 29.075
55.79 U/L
STANDARD_DEVIATION 26.447
57.15 U/L
STANDARD_DEVIATION 24.064
Diabetes Mellitus Status
Absent
15 Participants14 Participants10 Participants15 Participants54 Participants
Diabetes Mellitus Status
Present
11 Participants11 Participants16 Participants8 Participants46 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
1 Participants1 Participants1 Participants0 Participants3 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants1 Participants2 Participants0 Participants5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
20 Participants17 Participants16 Participants17 Participants70 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
6 Participants8 Participants9 Participants4 Participants27 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants0 Participants0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Other
2 Participants0 Participants2 Participants2 Participants6 Participants
Race/Ethnicity, Customized
Unknown
0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
White
21 Participants23 Participants21 Participants21 Participants86 Participants
Region of Enrollment
United States
26 Participants25 Participants26 Participants23 Participants100 Participants
Sex: Female, Male
Female
16 Participants15 Participants17 Participants17 Participants65 Participants
Sex: Female, Male
Male
10 Participants10 Participants9 Participants6 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 260 / 250 / 260 / 23
other
Total, other adverse events
10 / 2613 / 2514 / 2615 / 23
serious
Total, serious adverse events
1 / 260 / 250 / 261 / 23

Outcome results

Primary

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

Time frame: 16 weeks

Population: Safety Population: All patients who received at least 1 dose of study drug

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants With Adverse Events for TERN-101 Versus Placebo10 Participants
TERN-101 5 mgNumber of Participants With Adverse Events for TERN-101 Versus Placebo13 Participants
TERN-101 10 mgNumber of Participants With Adverse Events for TERN-101 Versus Placebo14 Participants
TERN-101 15 mgNumber of Participants With Adverse Events for TERN-101 Versus Placebo15 Participants
Secondary

Percent Change From Baseline in ALT Outcome Measure

Time frame: 12 weeks

Population: Efficacy Population: All randomized patients who received at least 1 dose of study drug

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
PlaceboPercent Change From Baseline in ALT Outcome Measure-5.33 percentage of change from baselineStandard Error 6.606
TERN-101 5 mgPercent Change From Baseline in ALT Outcome Measure-2.63 percentage of change from baselineStandard Error 6.743
TERN-101 10 mgPercent Change From Baseline in ALT Outcome Measure-17.99 percentage of change from baselineStandard Error 6.646
TERN-101 15 mgPercent Change From Baseline in ALT Outcome Measure-13.22 percentage of change from baselineStandard Error 7.246
p-value: 0.775595% CI: [-16.1, 21.5]ANCOVA
p-value: 0.179895% CI: [-31.3, 5.9]ANCOVA
p-value: 0.422995% CI: [-27.4, 11.6]ANCOVA
Secondary

Plasma Concentration of TERN-101 - AUC 0-24

Area under the curve

Time frame: 12 weeks (0-24 hours post dose)

Population: All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101. The minimum requirement for the calculation of AUC required: A minimum of 3 measurable concentration-time-points during the log-linear portion of the terminal elimination phase (after tmax), excluding Cmax; r²adj ≥ 0.80 for the regression of the log-concentration time data during the terminal elimination phase; Negative slope for log regression fit.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PlaceboPlasma Concentration of TERN-101 - AUC 0-241380 h*ng/mLGeometric Coefficient of Variation 96.7
TERN-101 5 mgPlasma Concentration of TERN-101 - AUC 0-241470 h*ng/mLGeometric Coefficient of Variation 29.7
TERN-101 10 mgPlasma Concentration of TERN-101 - AUC 0-242510 h*ng/mLGeometric Coefficient of Variation 13.3
Secondary

Plasma Concentration of TERN-101 - Cmax

Maximum observed concentration

Time frame: 12 Weeks (0-72 hours post dose)

Population: All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PlaceboPlasma Concentration of TERN-101 - Cmax116 ng/mLGeometric Coefficient of Variation 45
TERN-101 5 mgPlasma Concentration of TERN-101 - Cmax155 ng/mLGeometric Coefficient of Variation 158.8
TERN-101 10 mgPlasma Concentration of TERN-101 - Cmax389 ng/mLGeometric Coefficient of Variation 19
Secondary

Plasma Concentration of TERN-101 - t1/2

Determination of half-life

Time frame: 12 Weeks (0-72 hours post dose)

Population: All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101. The minimum requirement for the calculation of t1/2 required: A minimum of 3 measurable concentration-time-points during the log-linear portion of the terminal elimination phase (after Tmax), excluding Cmax; r²adj ≥ 0.80 for the regression of the log-concentration time data during the terminal elimination phase; and negative slope for log regression fit.

ArmMeasureValue (MEDIAN)
PlaceboPlasma Concentration of TERN-101 - t1/214.6 hour
TERN-101 5 mgPlasma Concentration of TERN-101 - t1/26.75 hour
TERN-101 10 mgPlasma Concentration of TERN-101 - t1/26 hour
Secondary

Plasma Concentration of TERN-101 - Tmax

Time to reach maximum measured plasma concentration

Time frame: 12 Weeks (0-72 hours post dose)

Population: All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101.

ArmMeasureValue (MEDIAN)
PlaceboPlasma Concentration of TERN-101 - Tmax1 hour
TERN-101 5 mgPlasma Concentration of TERN-101 - Tmax1 hour
TERN-101 10 mgPlasma Concentration of TERN-101 - Tmax0.5 hour

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026