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

NCT05415722 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TERNCB-2002
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 35

Brief 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 (NASH)

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic steatohepatitis (NASH); FXR agonist; Nonalcoholic Fatty Liver Disease (NAFLD); THR-β agonist

Outcome Measures

Primary Outcomes (1)

• 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 \[(Week 12 Value - Baseline Value)/Baseline Value\].

  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

  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

  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

  12 weeks

• Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%)

  16 weeks

Study Arms (7)

Arm 1: TERN-501 1 mg

EXPERIMENTAL

Orally administered.

Drug: TERN-501

Arm 2: TERN-501 3 mg

EXPERIMENTAL

Orally administered.

Drug: TERN-501

Arm 3: TERN-501 6 mg

EXPERIMENTAL

Orally administered.

Drug: TERN-501

Arm 4: TERN-501 3 mg + TERN-101 10 mg

EXPERIMENTAL

Orally administered.

Drug: TERN-501; Drug: TERN-101

Arm 5: TERN-501 6 mg + TERN-101 10 mg

EXPERIMENTAL

Orally administered.

Drug: TERN-501; Drug: TERN-101

Arm 6:TERN-101 10 mg

EXPERIMENTAL

Orally administered.

Drug: TERN-101

Arm 7: Matching placebo

PLACEBO COMPARATOR

Orally administered.

Other: Placebo

Interventions

TERN-501 DRUG

Investigational 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-101 DRUG

Investigational 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

Placebo OTHER

Matching placebo

Arm 7: Matching 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 diagnosed by prior biopsy and/or imaging criteria
• Written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Terns, Inc.: lead

Study Sites (35)

Site 1017: The Institute for Liver Health dba Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

Site 1018: Arizona Liver Health

Tucson, Arizona, 85712, United States

Location

Site 1004 Southern California Research Center

Coronado, California, 92118, United States

Location

Site 1061 Velocity Clinical Research, Gardena

Gardena, California, 90247, United States

Location

Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

Location

Site 1016 Ruane Clinical Research Group Inc.

Los Angeles, California, 90036, United States

Location

Site 1060 Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Site 1001 National Research Institute

Panorama City, California, 91402, United States

Location

Site 1040 Inland Empire Clinical Trials, LLC

Rialto, California, 92377, United States

Location

Site 1062 Excel Medical Clinical Trials, LLC

Boca Raton, Florida, 33434, United States

Location

Site 1057:Integrity Clinical Research, LLC

Doral, Florida, 33122, United States

Location

Site 1041: Florida Research Institute

Lakewood Rch, Florida, 34211, United States

Location

Site 1058 Optimus U Corporation

Miami, Florida, 33125, United States

Location

Site 1036 Schiff Center for Liver Diseases / University of Miami

Miami, Florida, 33136, United States

Location

Site 1045 University of Miami Hospital & Clinics, Sylvester Comp. Cancer Center

Miami, Florida, 33136, United States

Location

Site 1007: Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

Location

Site 1055: Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Site 1032 IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Site 1052: Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

Site 1054 Louisiana Research Center

Shreveport, Louisiana, 71105, United States

Location

Site 1063 GI Alliance - Flowood

Flowood, Mississippi, 39232, United States

Location

Site 1042: Lucas Research, Inc

Morehead City, North Carolina, 28557, United States

Location

Site 1059: Premier Medical Group

Clarksville, Tennessee, 37040, United States

Location

Site 1044: Quality Medical Research

Nashville, Tennessee, 37211, United States

Location

Site 1005:Texas Clinical Research Institute, LLC

Arlington, Texas, 76012, United States

Location

Site 1050: Pinnacle Clinical Research

Austin, Texas, 78757, United States

Location

Site 1051: South Texas Research Institute

Edinburg, Texas, 78539, United States

Location

Site 1043 Liver Specialists of Texas

Houston, Texas, 77030, United States

Location

Site 1046 Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Site 1039: Houston Research Institute

Houston, Texas, 77079, United States

Location

Site 1003: Clinical Trials of Texas, LLC

San Antonio, Texas, 78215, United States

Location

Site 1006: American Research Corporation

San Antonio, Texas, 78215, United States

Location

Site 1056: Pinnacle Clinical Research

San Antonio, Texas, 78229, United States

Location

Site 1053 Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond

Richmond, Virginia, 23236, United States

Location

Site 1022 Liver Institute Northwest

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 40500414 DERIVED

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

• Study Director

  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: June 8, 2022
• First Posted: June 13, 2022
• Study Start: June 28, 2022
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)