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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 : Completed
First Posted : June 13, 2022
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Terns, Inc.

Tracking Information
First Submitted Date  ICMJE June 8, 2022
First Posted Date  ICMJE June 13, 2022
Last Update Posted Date September 28, 2023
Actual Study Start Date  ICMJE July 7, 2022
Actual Primary Completion Date July 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2022)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2022)
  • 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 ]
  • 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 ]
  • 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 ]
  • Patient incidence of treatment emergent adverse events for all treatment groups [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE NASH - Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: TERN-501
    Investigational drug
  • Drug: TERN-101
    Investigational drug
  • Other: Placebo
    Matching placebo
Study Arms  ICMJE
  • Experimental: Arm 1: TERN-501 1 mg
    Orally administered.
    Intervention: Drug: TERN-501
  • Experimental: Arm 2: TERN-501 3 mg
    Orally administered.
    Intervention: Drug: TERN-501
  • Experimental: Arm 3: TERN-501 6 mg
    Orally administered.
    Intervention: Drug: TERN-501
  • Experimental: Arm 4: TERN-501 3 mg + TERN-101 10 mg
    Orally administered.
    Interventions:
    • Drug: TERN-501
    • Drug: TERN-101
  • Experimental: Arm 5: TERN-501 6 mg + TERN-101 10 mg
    Orally administered.
    Interventions:
    • Drug: TERN-501
    • Drug: TERN-101
  • Experimental: Arm 6:TERN-101 10 mg
    Orally administered.
    Intervention: Drug: TERN-101
  • Placebo Comparator: Arm 7: Matching placebo
    Orally administered.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2023)
162
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2022)
140
Actual Study Completion Date  ICMJE July 10, 2023
Actual Primary Completion Date July 10, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05415722
Other Study ID Numbers  ICMJE TERNCB-2002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Terns, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Terns, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Terns, Inc.
PRS Account Terns, Inc.
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP