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AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04897594
Recruitment Status : Completed
First Posted : May 21, 2021
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Terns, Inc.

Brief Summary:
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: TERN-201 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Triple
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Actual Study Start Date : May 20, 2021
Actual Primary Completion Date : September 2, 2022
Actual Study Completion Date : September 2, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1: TERN-201 dose level 1
Orally administered.
Drug: TERN-201
Investigational drug

Placebo Comparator: Part 1: Placebo
Orally Administered
Other: Placebo
Matching placebo

Experimental: Part 2: TERN-201 dose level 2
Orally administered
Drug: TERN-201
Investigational drug

Placebo Comparator: Part 2: Placebo
Orally administered
Other: Placebo
Matching placebo




Primary Outcome Measures :
  1. Subject incidence of adverse events for TERN-201 versus placebo [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Plasma concentration of TERN-201- AUC [ Time Frame: 12 weeks ]
    Area under the curve

  2. Plasma concentration of TERN-201- Cmax [ Time Frame: 12 weeks ]
    Maximum observed concentration

  3. Plasma concentration of TERN-201- Tmax [ Time Frame: 12 weeks ]
    Time to reach maximum measured plasma concentration

  4. Plasma concentration of TERN-201- T1/2 [ Time Frame: 12 weeks ]
    Determination of half-life

  5. Percent Change from baseline in plasma VAP-1/SSAO activity [ Time Frame: 12 weeks ]
  6. Urine concentration of TERN-201- CLr [ Time Frame: Day 1 ]
    Renal clearance



Information from the National Library of Medicine

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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

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 based on clinical characteristics or prior liver biopsy
  • ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
  • MRI-cT1 value> 800 ms
  • Written informed consent

Exclusion Criteria:

  • History or clinical evidence of chronic liver diseases other than NAFLD
  • History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
  • History of liver transplant, or current placement on a liver transplant list
  • Weight loss of > 5% total body weight within 3 months prior to Screening

Note: Other protocol-defined inclusion/exclusion criteria that apply


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): NCT04897594


Locations
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United States, Arizona
Terns Clinical Study Site 1018
Tucson, Arizona, United States, 85712
Terns Clinical Study Site 1024
Tucson, Arizona, United States, 85712
United States, California
Terns Clinical Study Site 1004
Coronado, California, United States, 92117
Terns Clinical Study Site 1039
Los Angeles, California, United States, 90048
Terns Clinical Study Site 1001
Panorama City, California, United States, 91402
Terns Clinical Study Site 1040
Rialto, California, United States, 92377
Terns Clinical Study Site 1013
San Diego, California, United States, 92093
United States, Louisiana
Terns Clinical Study Site 1010
Bastrop, Louisiana, United States, 71220
United States, Texas
Terns Clinical Study Site 1006
San Antonio, Texas, United States, 78215
Terns Clinical Study Site 1003
San Antonio, Texas, United States, 78229
Terns Clinical Study Site 1019
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Terns, Inc.
Investigators
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Study Director: clinicaltrials@ternspharma.com Terns, Inc.
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Responsible Party: Terns, Inc.
ClinicalTrials.gov Identifier: NCT04897594    
Other Study ID Numbers: TERN201-1007
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
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.:
Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO)
Nonalcoholic steatohepatitis (NASH)
Nonalcoholic Fatty Liver Disease (NAFLD)
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases