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

Sponsor
Terns, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04897594
Collaborator
(none)
52
11
4
16.4
4.7
0.3

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Subject incidence of adverse events for TERN-201 versus placebo [16 weeks]

Secondary Outcome Measures

  1. Plasma concentration of TERN-201- AUC [12 weeks]

    Area under the curve

  2. Plasma concentration of TERN-201- Cmax [12 weeks]

    Maximum observed concentration

  3. Plasma concentration of TERN-201- Tmax [12 weeks]

    Time to reach maximum measured plasma concentration

  4. Plasma concentration of TERN-201- T1/2 [12 weeks]

    Determination of half-life

  5. Percent Change from baseline in plasma VAP-1/SSAO activity [12 weeks]

  6. Urine concentration of TERN-201- CLr [Day 1]

    Renal clearance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Terns Clinical Study Site 1018 Tucson Arizona United States 85712
2 Terns Clinical Study Site 1024 Tucson Arizona United States 85712
3 Terns Clinical Study Site 1004 Coronado California United States 92117
4 Terns Clinical Study Site 1039 Los Angeles California United States 90048
5 Terns Clinical Study Site 1001 Panorama City California United States 91402
6 Terns Clinical Study Site 1040 Rialto California United States 92377
7 Terns Clinical Study Site 1013 San Diego California United States 92093
8 Terns Clinical Study Site 1010 Bastrop Louisiana United States 71220
9 Terns Clinical Study Site 1006 San Antonio Texas United States 78215
10 Terns Clinical Study Site 1003 San Antonio Texas United States 78229
11 Terns Clinical Study Site 1019 San Antonio Texas United States 78229

Sponsors and Collaborators

  • Terns, Inc.

Investigators

  • Study Director: clinicaltrials@ternspharma.com, Terns, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Terns, Inc.
ClinicalTrials.gov Identifier:
NCT04897594
Other Study ID Numbers:
  • TERN201-1007
First Posted:
May 21, 2021
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Terns, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022