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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

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ClinicalTrials.gov Identifier: NCT05415722
Recruitment Status : Active, not recruiting
First Posted : June 13, 2022
Last Update Posted : April 14, 2023
Sponsor:
Information provided by (Responsible Party):
Terns, Inc.

Study Description
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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)

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: TERN-501 Drug: TERN-101 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a 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)
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: TERN-501 1 mg
Orally administered.
 Drug: TERN-501
Investigational drug
Experimental: Arm 2: TERN-501 3 mg
Orally administered.
 Drug: TERN-501
Investigational drug
Experimental: Arm 3: TERN-501 6 mg
Orally administered.
 Drug: TERN-501
Investigational drug
Experimental: Arm 4: TERN-501 3 mg + TERN-101 10 mg
Orally administered.
 Drug: TERN-501
Investigational drug

Drug: TERN-101
Investigational drug
Experimental: Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
 Drug: TERN-501
Investigational drug

Drug: TERN-101
Investigational drug
Experimental: Arm 6:TERN-101 10 mg
Orally administered.
 Drug: TERN-101
Investigational drug
Placebo Comparator: Arm 7: Matching placebo
Orally administered.
 Other: Placebo
Matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. Relative change from baseline in MRI-PDFF at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in cT1 relaxation time at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo [ Time Frame: 12 weeks ]
  2. Relative change from baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo [ Time Frame: 12 weeks ]
  3. Change from baseline in cT1 relaxation time at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo [ Time Frame: 12 weeks ]
  4. Patient incidence of treatment emergent adverse events for all treatment groups [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05415722


Locations
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Sponsors and Collaborators
Terns, Inc.
Investigators
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Study Director: Study Director Terns, Inc.
More Information
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Responsible Party: Terns, Inc.
ClinicalTrials.gov Identifier: NCT05415722    
Other Study ID Numbers: TERNCB-2002
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: April 14, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terns, Inc.:
Nonalcoholic steatohepatitis (NASH)
FXR agonist
Nonalcoholic Fatty Liver Disease (NAFLD)
THR-β agonist
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases