NASH - Nonalcoholic SteatohepatitisPhase 2NCT05415722

DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis

A Phase 2 study testing TERN-501 and TERN-101 in people with NASH - Nonalcoholic Steatohepatitis, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 35 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 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis… 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-501 and TERN-101
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 162 participants
Where: 35 sitesUnited States
Study dates: 28 Jun 2022to 10 Jul 2023
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 diagnosed by prior biopsy and/or imaging criteria
Written informed consent

Who cannot join

History or clinical evidence of chronic liver diseases other than NAFLD
History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment,
History of liver transplant, or current placement on a liver transplant list
Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy.
Abnormal TSH or free T4 levels
Weight loss of > 5% total body weight within 3 months prior to Screening

Show all 11Show fewer

Uncontrolled diabetes
Uncontrolled hyperlipidemia
Unstable cardiovascular disease
Excessive alcohol consumption
Other protocol-defined I/E criteria that apply.

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Site 1005:Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
Site 1050: Pinnacle Clinical Research
Austin, Texas, 78757
Site 1062 Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33434
Site 1017: The Institute for Liver Health dba Arizona Liver Health
Chandler, Arizona, 85224
Site 1059: Premier Medical Group
Clarksville, Tennessee, 37040
Site 1004 Southern California Research Center
Coronado, California, 92118
Site 1057:Integrity Clinical Research, LLC
Doral, Florida, 33122
Site 1051: South Texas Research Institute
Edinburg, Texas, 78539
Site 1063 GI Alliance - Flowood
Flowood, Mississippi, 39232
Site 1061 Velocity Clinical Research, Gardena
Gardena, California, 90247
Site 1043 Liver Specialists of Texas
Houston, Texas, 77030
Site 1046 Houston Methodist Hospital
Houston, Texas, 77030
Site 1039: Houston Research Institute
Houston, Texas, 77079
Site 1032 IU Health University Hospital
Indianapolis, Indiana, 46202
Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute
La Jolla, California, 92037
Site 1041: Florida Research Institute
Lakewood Rch, Florida, 34211
Site 1016 Ruane Clinical Research Group Inc.
Los Angeles, California, 90036
Site 1058 Optimus U Corporation
Miami, Florida, 33125
Site 1036 Schiff Center for Liver Diseases / University of Miami
Miami, Florida, 33136
Site 1045 University of Miami Hospital & Clinics, Sylvester Comp. Cancer Center
Miami, Florida, 33136
Site 1007: Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
Site 1060 Catalina Research Institute, LLC
Montclair, California, 91763
Site 1042: Lucas Research, Inc
Morehead City, North Carolina, 28557
Site 1044: Quality Medical Research
Nashville, Tennessee, 37211
Site 1001 National Research Institute
Panorama City, California, 91402
Site 1055: Progressive Medical Research
Port Orange, Florida, 32127
Site 1040 Inland Empire Clinical Trials, LLC
Rialto, California, 92377
Site 1053 Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23236
Site 1003: Clinical Trials of Texas, LLC
San Antonio, Texas, 78215
Site 1006: American Research Corporation
San Antonio, Texas, 78215
Site 1056: Pinnacle Clinical Research
San Antonio, Texas, 78229
Site 1022 Liver Institute Northwest
Seattle, Washington, 98105
Site 1054 Louisiana Research Center
Shreveport, Louisiana, 71105
Site 1018: Arizona Liver Health
Tucson, Arizona, 85712
Site 1052: Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as Well as in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis (NASH)

Conditions: NASH - Nonalcoholic Steatohepatitis
Being tested: TERN-501, TERN-101, Placebo
Keywords: Nonalcoholic steatohepatitis (NASH), FXR agonist, Nonalcoholic Fatty Liver Disease (NAFLD), THR-β agonist
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-501Drug
Investigational drug
TERN-101Drug
Investigational drug
PlaceboOther
Matching placebo

Study groups in NCT05415722
Study group	Role	What they receive
Arm 1: TERN-501 1 mg	Experimental	Orally administered. Receives: Drug: TERN-501
Arm 2: TERN-501 3 mg	Experimental	Orally administered. Receives: Drug: TERN-501
Arm 3: TERN-501 6 mg	Experimental	Orally administered. Receives: Drug: TERN-501
Arm 4: TERN-501 3 mg + TERN-101 10 mg	Experimental	Orally administered. Receives: Drug: TERN-501; Drug: TERN-101
Arm 5: TERN-501 6 mg + TERN-101 10 mg	Experimental	Orally administered. Receives: Drug: TERN-501; Drug: TERN-101
Arm 6:TERN-101 10 mg	Experimental	Orally administered. Receives: Drug: TERN-101
Arm 7: Matching 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.

Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x [(Week 12 Value - Baseline Value)/Baseline Value].
Measured: 12 weeks

Secondary outcomes (4)

Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo
Corrected T1 (cT1) is a quantitative MRI relaxation parameter that measures liver inflammation and fibrosis. Change from baseline is calculated for each subject as (Week 12 Value - Baseline Value).
Measured: 12 weeks
Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x [(Week 12 Value - Baseline Value)/Baseline Value].
Measured: 12 weeks
Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo
Corrected T1 (cT1) is a quantitative MRI relaxation parameter that measures liver inflammation and fibrosis. Change from baseline is calculated for each subject as (Week 12 Value - Baseline Value).
Measured: 12 weeks
Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%)
This outcome measures the number and percentage of participants with any Treatment Emergent Adverse Event (TEAE) for All Treatment Groups (0% Threshold). TEAEs by System Organ Class and Preferred Term meeting the 5% Threshold are reported in the Other Adverse Events section.
Measured: 16 weeks

Timeline

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

28 Jun 202210 Jul 2023

First posted13 Jun 2022
Study start28 Jun 2022
Primary completion10 Jul 2023
Study completion10 Jul 2023

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.
Publications (1)Papers the sponsor has linked to this study.
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: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05415722
Sponsor's protocol ID: TERNCB-2002
Status last verified: Mar 2025
First submitted: 8 Jun 2022
Last updated: 12 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Noureddin M, Alkhouri N, Lawitz EJ, Kowdley KV, Loomba R, Lee L, Jones C, Schlegel A, Marmon T, Anderson K, Li Y, Quirk E, Harrison SA. TERN-501 monotherapy and combination therapy with TERN-101 in metabolic dysfunction-associated steatohepatitis: the randomized phase 2a DUET trial. Nat Med. 2025 Jul;31(7):2297-2305. doi: 10.1038/s41591-025-03722-7. Epub 2025 Jun 11.
PubMed 40500414

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

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RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Overweight and/or Obesity, Metabolic Syndrome
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
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All NASH - Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as Well as in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT05415722
Acronym / sponsor ID: TERNCB-2002
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Nonalcoholic steatohepatitis (NASH), FXR agonist, Nonalcoholic Fatty Liver Disease (NAFLD), THR-β agonist
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 28 Jun 2022 (actual)
Primary completion: 10 Jul 2023 (actual)
Study completion: 10 Jul 2023 (actual)
First posted: 13 Jun 2022 (actual)
Results: Posted 12 Mar 2025

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 7

Arm	Type	Receives
Arm 1: TERN-501 1 mg	Experimental	Drug: TERN-501Orally administered.
Arm 2: TERN-501 3 mg	Experimental	Drug: TERN-501Orally administered.
Arm 3: TERN-501 6 mg	Experimental	Drug: TERN-501Orally administered.
Arm 4: TERN-501 3 mg + TERN-101 10 mg	Experimental	Drug: TERN-501, Drug: TERN-101Orally administered.
Arm 5: TERN-501 6 mg + TERN-101 10 mg	Experimental	Drug: TERN-501, Drug: TERN-101Orally administered.
Arm 6:TERN-101 10 mg	Experimental	Drug: TERN-101Orally administered.
Arm 7: Matching 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 (4 listed)

Male or female, 18 to 75 years of age
Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
Presumed NASH diagnosed by prior biopsy and/or imaging criteria
Written informed consent

Key exclusion criteria (11 listed)

History or clinical evidence of chronic liver diseases other than NAFLD
History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment,
History of liver transplant, or current placement on a liver transplant list
Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy.
Abnormal TSH or free T4 levels

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-501Investigational drug	Drug	Arm 1: TERN-501 1 mg, Arm 2: TERN-501 3 mg, Arm 3: TERN-501 6 mg, Arm 4: TERN-501 3 mg + TERN-101 10 mg, Arm 5: TERN-501 6 mg + TERN-101 10 mg
TERN-101Investigational drug	Drug	Arm 4: TERN-501 3 mg + TERN-101 10 mg, Arm 5: TERN-501 6 mg + TERN-101 10 mg, Arm 6:TERN-101 10 mg
PlaceboMatching placebo	Other	Arm 7: Matching placebo

Primary outcome

Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.
Time frame: 12 weeks
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x [(Week 12 Value - Baseline Value)/Baseline Value].

4 secondary outcomes

Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo
Time frame: 12 weeks
Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo
Time frame: 12 weeks
Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo
Time frame: 12 weeks
Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%)
Time frame: 16 weeks

Results and safety

Results posted to the registry on 12 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: TERN-501 1 mg	23	23
Arm 2: TERN-501 3 mg	23	20
Arm 3: TERN-501 6 mg	22	22
Arm 4: TERN-501 3 mg + TERN-101 10 mg	23	19
Arm 5: TERN-501 6 mg + TERN-101 10 mg	23	21
Arm 6:TERN-101 10 mg	24	23
Arm 7: Matching Placebo	24	21

Primary outcome: Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.

Time frame: 12 weeks. Least squares mean (Standard Error). Unit: Percent change from baseline

Measure	Arm 1: TERN-501 1 mg n = 23	Arm 2: TERN-501 3 mg n = 19	Arm 3: TERN-501 6 mg n = 18	Arm 7: Matching Placebo n = 21
Value	-15.39 (5.186)	-27.48 (5.740)	-44.81 (5.856)	-4.01 (5.416)

Arm 1: TERN-501 1 mg vs Arm 7: Matching Placebo: Mean Difference (Final Values): -11.39 (95% CI -26.178 to 3.406), p = 0.1303, ANCOVA
Arm 2: TERN-501 3 mg vs Arm 7: Matching Placebo: Mean Difference (Final Values): -23.47 (95% CI -39.140 to -7.799), p = 0.0036, ANCOVA
Arm 3: TERN-501 6 mg vs Arm 7: Matching Placebo: Mean Difference (Final Values): -40.80 (95% CI -56.545 to -25.064), p <0.0001, ANCOVA

Population analysed: Efficacy Analysis Set: All patients who were randomized and received at least 1 dose of the study. Primary analyses were based on observed data, i.e. no imputation was performed for missing data at Week 12. Therefore, the number of patients analyzed at Week 12 may not be the same as the number of patients treated.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: TERN-501 1 mg	1 of 23 (4.3%)	2 of 23 (8.7%)	0 of 23
Arm 2: TERN-501 3 mg	0 of 23 (0%)	8 of 23 (34.8%)	0 of 23
Arm 3: TERN-501 6 mg	0 of 22 (0%)	5 of 22 (22.7%)	0 of 22
Arm 4: TERN-501 3 mg + TERN-101 10 mg	0 of 23 (0%)	10 of 23 (43.5%)	0 of 23
Arm 5: TERN-501 6 mg + TERN-101 10 mg	0 of 23 (0%)	6 of 23 (26.1%)	0 of 23
Arm 6:TERN-101 10 mg	2 of 24 (8.3%)	5 of 24 (20.8%)	0 of 24
Arm 7: Matching Placebo	0 of 24 (0%)	5 of 24 (20.8%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40500414Noureddin M, Alkhouri N, Lawitz EJ, Kowdley KV, Loomba R, Lee L, Jones C, Schlegel A, Marmon T, Anderson K, Li Y, Quirk E, Harrison SA. TERN-501 monotherapy and combination therapy with TERN-101 in metabolic dysfunction-associated steatohepatitis: the randomized phase 2a DUET trial. Nat Med. 2025 Jul;31(7):2297-2305. doi: 10.1038/s41591-025-03722-7. Epub 2025 Jun 11.
Individual participant dataSharing planned: No

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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.

Study Director study director

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

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

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 11 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 12 Mar 2025). 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?

Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo. (time frame: 12 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 NCT05415722, which also lists 1 linked publication.

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 12 Mar 2025.