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
R
Raj Vuppalanchi, MD
Primary Investigator
Not Recruiting
18 years - 75 years
All
Phase
2
140 participants needed
1 Location
Brief description of study
This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Studyvaluate 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)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: NASH - Nonalcoholic Steatohepatitis
-
Age: 18 years - 75 years
-
Gender: All
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, hepaticdecompensation 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 patientswith 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.
Updated on
01 Aug 2024.
Study ID: TERNCB-2002
