Status:
COMPLETED
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
Lead Sponsor:
Terns, Inc.
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2023
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT05415722
Start Date
June 28 2022
End Date
July 10 2023
Last Update
March 12 2025
Active Locations (35)
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1
Site 1017: The Institute for Liver Health dba Arizona Liver Health
Chandler, Arizona, United States, 85224
2
Site 1018: Arizona Liver Health
Tucson, Arizona, United States, 85712
3
Site 1004 Southern California Research Center
Coronado, California, United States, 92118
4
Site 1061 Velocity Clinical Research, Gardena
Gardena, California, United States, 90247