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

• ClinicalTrials.gov Identifier: NCT05415722
• Recruitment Status: Completed
• First Posted: June 13, 2022
• Last Update Posted: September 28, 2023
• Sponsor: Terns, Inc.
• Information provided by (Responsible Party): Terns, Inc.

Tracking Information

• First Submitted Date: June 8, 2022
• First Posted Date: June 13, 2022
• Last Update Posted Date: September 28, 2023
• Actual Study Start Date: July 7, 2022
• Actual Primary Completion Date: July 10, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: NASH - Nonalcoholic Steatohepatitis

Intervention

• Drug: TERN-501
  Investigational drug
• Drug: TERN-101
  Investigational drug
• Other: Placebo
  Matching placebo

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 13, 2023): 162
• Original Estimated Enrollment (submitted: June 8, 2022): 140
• Actual Study Completion Date: July 10, 2023
• Actual Primary Completion Date: July 10, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05415722
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Terns, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Terns, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; Terns, Inc.

• PRS Account: Terns, Inc.
• Verification Date: September 2023