Phase 2
Completed N=162
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
NASH - Nonalcoholic Steatohepatitis
Source: ClinicalTrials.gov NCT05415722 ↗
Enrolled (actual)
162
Serious AEs
1.8%
Results posted
Mar 2025
Primary outcomePrimary: Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo. — -15.39; -27.48; -44.81; -4.01 Percent change from baseline — p=0.1303
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo. |
-15.39; -27.48; -44.81; -4.01 | 0.1303 |
| SECONDARY Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo |
-28.2; -25.6; -72.0; 3.6 | 0.1289 |
| SECONDARY Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo |
-20.75; -47.74; -4.01 | 0.0358 sig |
| SECONDARY Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo |
-59.0; -65.5; 3.6 | 0.0053 sig |
| SECONDARY Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%) |
11; 13; 11; 14; 12; 10 | — |
Eligibility Criteria
Key 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 diagnosed by prior biopsy and/or imaging criteria
- Written informed consent
Key Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05415722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.