Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: TERN-501 1 mg | Experimental | Orally administered. |
|
| Arm 2: TERN-501 3 mg | Experimental | Orally administered. |
|
| Arm 3: TERN-501 6 mg | Experimental | Orally administered. |
|
| Arm 4: TERN-501 3 mg + TERN-101 10 mg | Experimental | Orally administered. |
|
| Arm 5: TERN-501 6 mg + TERN-101 10 mg | Experimental | Orally administered. |
|
| Arm 6:TERN-101 10 mg | Experimental | Orally administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TERN-501 | Drug | Investigational drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined I/E criteria that apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Terns, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1017: The Institute for Liver Health dba Arizona Liver Health | Chandler | Arizona | 85224 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40500414 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 591 patients were screened with 429 patients failing screening.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: TERN-501 1 mg | Orally administered. TERN-501: Investigational drug |
| FG001 | Arm 2: TERN-501 3 mg | Orally administered. TERN-501: Investigational drug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2022 | Aug 16, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Arm 7: Matching placebo | Placebo Comparator | Orally administered. |
|
| TERN-101 | Drug | Investigational drug |
|
| Placebo | Other | Matching placebo |
|
| 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]. |
| 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). | 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. | 16 weeks |
| Site 1018: Arizona Liver Health |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Site 1004 Southern California Research Center | Coronado | California | 92118 | United States |
| Site 1061 Velocity Clinical Research, Gardena | Gardena | California | 90247 | United States |
| Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute | La Jolla | California | 92037 | United States |
| Site 1016 Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | United States |
| Site 1060 Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| Site 1001 National Research Institute | Panorama City | California | 91402 | United States |
| Site 1040 Inland Empire Clinical Trials, LLC | Rialto | California | 92377 | United States |
| Site 1062 Excel Medical Clinical Trials, LLC | Boca Raton | Florida | 33434 | United States |
| Site 1057:Integrity Clinical Research, LLC | Doral | Florida | 33122 | United States |
| Site 1041: Florida Research Institute | Lakewood Rch | Florida | 34211 | United States |
| Site 1058 Optimus U Corporation | Miami | Florida | 33125 | United States |
| Site 1036 Schiff Center for Liver Diseases / University of Miami | Miami | Florida | 33136 | United States |
| Site 1045 University of Miami Hospital & Clinics, Sylvester Comp. Cancer Center | Miami | Florida | 33136 | United States |
| Site 1007: Floridian Clinical Research, LLC | Miami Lakes | Florida | 33016 | United States |
| Site 1055: Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Site 1032 IU Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Site 1052: Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| Site 1054 Louisiana Research Center | Shreveport | Louisiana | 71105 | United States |
| Site 1063 GI Alliance - Flowood | Flowood | Mississippi | 39232 | United States |
| Site 1042: Lucas Research, Inc | Morehead City | North Carolina | 28557 | United States |
| Site 1059: Premier Medical Group | Clarksville | Tennessee | 37040 | United States |
| Site 1044: Quality Medical Research | Nashville | Tennessee | 37211 | United States |
| Site 1005:Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | United States |
| Site 1050: Pinnacle Clinical Research | Austin | Texas | 78757 | United States |
| Site 1051: South Texas Research Institute | Edinburg | Texas | 78539 | United States |
| Site 1043 Liver Specialists of Texas | Houston | Texas | 77030 | United States |
| Site 1046 Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Site 1039: Houston Research Institute | Houston | Texas | 77079 | United States |
| Site 1003: Clinical Trials of Texas, LLC | San Antonio | Texas | 78215 | United States |
| Site 1006: American Research Corporation | San Antonio | Texas | 78215 | United States |
| Site 1056: Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| Site 1053 Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23236 | United States |
| Site 1022 Liver Institute Northwest | Seattle | Washington | 98105 | United States |
| FG002 | Arm 3: TERN-501 6 mg | Orally administered. TERN-501: Investigational drug |
| FG003 | Arm 4: TERN-501 3 mg + TERN-101 10 mg | Orally administered. TERN-501: Investigational drug TERN-101: Investigational drug |
| FG004 | Arm 5: TERN-501 6 mg + TERN-101 10 mg | Orally administered. TERN-501: Investigational drug TERN-101: Investigational drug |
| FG005 | Arm 6:TERN-101 10 mg | Orally administered. TERN-101: Investigational drug |
| FG006 | Arm 7: Matching Placebo | Orally administered. Placebo: Matching placebo |
| Treated |
|
| Discontinued Treatment | Patient completed the study but did not complete the treatment |
|
| COMPLETED | Patient completed the study |
|
| NOT COMPLETED |
|
|
Patients who were randomized and received at least 1 dose of study drug were included in the Efficacy Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: TERN-501 1 mg | Orally administered. TERN-501: Investigational drug |
| BG001 | Arm 2: TERN-501 3 mg | Orally administered. TERN-501: Investigational drug |
| BG002 | Arm 3: TERN-501 6 mg | Orally administered. TERN-501: Investigational drug |
| BG003 | Arm 4: TERN-501 3 mg + TERN-101 10 mg | Orally administered. TERN-501: Investigational drug TERN-101: Investigational drug |
| BG004 | Arm 5: TERN-501 6 mg + TERN-101 10 mg | Orally administered. TERN-501: Investigational drug TERN-101: Investigational drug |
| BG005 | Arm 6:TERN-101 10 mg | Orally administered. TERN-101: Investigational drug |
| BG006 | Arm 7: Matching Placebo | Orally administered. Placebo: Matching placebo |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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]. | 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. | Posted | Least Squares Mean | Standard Error | Percent change from baseline | 12 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Efficacy Analysis Set: All randomized patients who received at least 1 dose of study drug. 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. | Posted | Least Squares Mean | Standard Error | msec | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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]. | Efficacy Analysis Set: All randomized patients who received at least 1 dose of study drug. 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. | Posted | Least Squares Mean | Standard Error | Percent change from baseline | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Efficacy Analysis Set: All randomized patients who received at least 1 dose of study drug. 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. | Posted | Least Squares Mean | Standard Error | msec | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All 162 patients who were randomized and received at least 1 dose of study drug were included in the Safety Analysis Set | Posted | Count of Participants | Participants | 16 weeks |
|
16 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: TERN-501 1 mg | Orally administered. TERN-501: Investigational drug | 0 | 23 | 1 | 23 | 2 | 23 |
| EG001 | Arm 2: TERN-501 3 mg | Orally administered. TERN-501: Investigational drug | 0 | 23 | 0 | 23 | 8 | 23 |
| EG002 | Arm 3: TERN-501 6 mg | Orally administered. TERN-501: Investigational drug | 0 | 22 | 0 | 22 | 5 | 22 |
| EG003 | Arm 4: TERN-501 3 mg + TERN-101 10 mg | Orally administered. TERN-501: Investigational drug TERN-101: Investigational drug | 0 | 23 | 0 | 23 | 10 | 23 |
| EG004 | Arm 5: TERN-501 6 mg + TERN-101 10 mg | Orally administered. TERN-501: Investigational drug TERN-101: Investigational drug | 0 | 23 | 0 | 23 | 6 | 23 |
| EG005 | Arm 6:TERN-101 10 mg | Orally administered. TERN-101: Investigational drug | 0 | 24 | 2 | 24 | 5 | 24 |
| EG006 | Arm 7: Matching Placebo | Orally administered. Placebo: Matching placebo | 0 | 24 | 0 | 24 | 5 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Terns, Inc. | +1 650-525-5535 | 101 | clinicaltrials@ternspharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2023 | Aug 16, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Asian |
|
| Not reported |
|
| Other (Puerto Rican) |
|
| Unknown |
|
| ANCOVA |
| 0.0036 |
| Mean Difference (Final Values) |
| -23.47 |
| Standard Error of the Mean |
| 7.924 |
| 2-Sided |
| 95 |
| -39.140 |
| -7.799 |
| Superiority |
| Arm 3 compared to Placebo | ANCOVA | <0.0001 | Mean Difference (Final Values) | -40.80 | Standard Error of the Mean | 7.960 | 2-Sided | 95 | -56.545 | -25.064 | Superiority |
Orally administered.
Placebo: Matching placebo
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG004 | Arm 5: TERN-501 6 mg + TERN-101 10 mg | Orally administered. TERN-501: Investigational drug TERN-101: Investigational drug |
| OG005 | Arm 6:TERN-101 10 mg | Orally administered. TERN-101: Investigational drug |
| OG006 | Arm 7: Matching Placebo | Orally administered. Placebo: Matching placebo |
|
|