NASH - Nonalcoholic SteatohepatitisPhase 2NCT04328077

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

A Phase 2 study testing TERN-101 in people with NASH - Nonalcoholic Steatohepatitis, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NASH - Nonalcoholic Steatohepatitis
What is being tested?: TERN-101
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 101 participants
Where: 31 sitesUnited States
Study dates: 18 Jun 2020to 19 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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/exclusion criteria could apply

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

United States31 sites

Terns Clinical Study Site 1005
Arlington, Texas, 76012
Terns Clinical Study Site 1002
Baltimore, Maryland, 21202
Terns Clinical Study Site 1010
Bastrop, Louisiana, 71220
Terns Clinical Study Site 1011
Boston, Massachusetts, 02118
Terns Clinical Study Site 1017
Chandler, Arizona, 85224
Terns Clinical Study Site 1004
Coronado, California, 92117
Terns Clinical Study Site 1027
Durham, North Carolina, 27710
Terns Clinical Study Site 1038
Florham Park, New Jersey, 07932
Terns Clinical Study Site 1035
Fresno, California, 93720
Terns Clinical Study Site 1012
Gainesville, Florida, 32610
Terns Clinical Study Site 1025
Georgetown, Texas, 78628
Terns Clinical Study Site 1014
Hermitage, Tennessee, 37076
Terns Clinical Study Site 1007
Hialeah, Florida, 33013
Terns Clinical Study Site 1028
Hialeah, Florida, 33014
Terns Clinical Study Site 1021
Houston, Texas, 77030
Terns Clinical Study Site 1029
Houston, Texas, 77030
Terns Clinical Study Site 1032
Indianapolis, Indiana, 46202
Terns Clinical Study Site 1013
La Jolla, California, 92037
Terns Clinical Study Site 1016
Los Angeles, California, 90036
Terns Clinical Study Site 1009
Miami, Florida, 33166
Terns Clinical Study Site 1008
Montclair, California, 91763
Terns Clinical Study Site 1037
New Orleans, Louisiana, 70121
Terns Clinical Study Site 1033
Orlando, Florida, 32806
Terns Clinical Study Site 1001
Panorama City, California, 91402
Terns Clinical Study Site 1006
San Antonio, Texas, 78215
Terns Clinical Study Site 1003
San Antonio, Texas, 78229
Terns Clinical Study Site 1019
San Antonio, Texas, 78229
Terns Clinical Study Site 1022
Seattle, Washington, 98105
Terns Clinical Study Site 1023
Shreveport, Louisiana, 71105
Terns Clinical Study Site 1018
Tucson, Arizona, 85712
Terns Clinical Study Site 1024
Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: 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)

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
Being tested: TERN-101, Placebo
Keywords: Farnesoid X receptor, NASH, Nonalcoholic Steatohepatitis, NAFLD, Nonalcoholic Fatty Liver Disease, FXR
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TERN-101Drug
Investigational drug
PlaceboOther
Matching placebo

Study groups in NCT04328077
Study group	Role	What they receive
TERN-101 dose level 1	Experimental	Orally administered. Receives: Drug: TERN-101
TERN-101 dose level 2	Experimental	Orally administered. Receives: Drug: TERN-101
TERN-101 dose level 3	Experimental	Orally administered. Receives: Drug: TERN-101
Placebo	Placebo comparator	Orally administered. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events for TERN-101 Versus Placebo
Measured: 16 weeks

Secondary outcomes (5)

Percent Change From Baseline in ALT Outcome Measure
Measured: 12 weeks
Plasma Concentration of TERN-101 - AUC 0-24
Area under the curve
Measured: 12 weeks (0-24 hours post dose)
Plasma Concentration of TERN-101 - Cmax
Maximum observed concentration
Measured: 12 Weeks (0-72 hours post dose)
Plasma Concentration of TERN-101 - Tmax
Time to reach maximum measured plasma concentration
Measured: 12 Weeks (0-72 hours post dose)
Plasma Concentration of TERN-101 - t1/2
Determination of half-life
Measured: 12 Weeks (0-72 hours post dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 202019 May 2021

First posted31 Mar 2020
Study start18 Jun 2020
Primary completion19 May 2021
Study completion19 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04328077
Sponsor's protocol ID: TERN101-2001
Status last verified: Jul 2022
First submitted: 13 Mar 2020
Last updated: 9 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)

All NASH - Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04328077
Acronym / sponsor ID: TERN101-2001
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Farnesoid X receptor, NASH, Nonalcoholic Steatohepatitis, NAFLD, Nonalcoholic Fatty Liver Disease, FXR
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 18 Jun 2020 (actual)
Primary completion: 19 May 2021 (actual)
Study completion: 19 May 2021 (actual)
First posted: 31 Mar 2020 (actual)
Results: Posted 14 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
TERN-101 dose level 1	Experimental	Drug: TERN-101Orally administered.
TERN-101 dose level 2	Experimental	Drug: TERN-101Orally administered.
TERN-101 dose level 3	Experimental	Drug: TERN-101Orally administered.
Placebo	Placebo comparator	Other: PlaceboOrally administered.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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 %

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TERN-101Investigational drug	Drug	TERN-101 dose level 1, TERN-101 dose level 2, TERN-101 dose level 3
PlaceboMatching placebo	Other	Placebo

Primary outcome

Number of Participants With Adverse Events for TERN-101 Versus Placebo
Time frame: 16 weeks

5 secondary outcomes

Percent Change From Baseline in ALT Outcome Measure
Time frame: 12 weeks
Plasma Concentration of TERN-101 - AUC 0-24
Time frame: 12 weeks (0-24 hours post dose)
Plasma Concentration of TERN-101 - Cmax
Time frame: 12 Weeks (0-72 hours post dose)
Plasma Concentration of TERN-101 - Tmax
Time frame: 12 Weeks (0-72 hours post dose)
Plasma Concentration of TERN-101 - t1/2
Time frame: 12 Weeks (0-72 hours post dose)

Results and safety

Results posted to the registry on 14 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	26	26
TERN-101 5mg	25	23
TERN-101 10mg	26	25
TERN-101 15mg	24	21

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

Time frame: 16 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 26	TERN-101 5 mg n = 25	TERN-101 10 mg n = 26	TERN-101 15 mg n = 23
Value	10	13	14	15

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

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 26 (3.8%)	10 of 26 (38.5%)	0 of 26
TERN-101 5mg	0 of 25 (0%)	13 of 25 (52%)	0 of 25
TERN-101 10mg	0 of 26 (0%)	14 of 26 (53.8%)	0 of 26
TERN-101 15mg	1 of 23 (4.3%)	15 of 23 (65.2%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for NASH - Nonalcoholic Steatohepatitis

Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

clinicaltrials@ternspharma.com study director

Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

31 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TERN-101 in people with NASH - Nonalcoholic Steatohepatitis, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events for TERN-101 Versus Placebo (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04328077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.