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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05357248
Other study ID # BT-NCBT-00x
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2022
Est. completion date December 7, 2022

Study information

Verified date December 2022
Source Better Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This single arm interventional cohort study is designed to explore the feasibility of using BT-NCBT-00x to improve liver fat, inflammation, and stiffness in patients diagnosed with NAFLD or NASH over a 3 month intervention.


Description:

The treatment, BT-NCBT-00x, consists of a software as a medical device developed by the study Sponsor, Better Therapeutics. It delivers treatment to participants with cardiometabolic disease, using behavioral therapy that targets individual behaviors related to improving dietary quality and physical activity. The study evaluates the use of this behavioral therapy and its effect on clinical measures such as percent liver fat as measured by MRI-PDFF, and Fibroscan Controlled Attenuation Parameter score, liver stiffness as measured by Fibroscan Vibration Controlled Transient Elastography in kPA, body weight and ALT. Participants in this feasibility study will have access to the treatment for 3- months.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 7, 2022
Est. primary completion date November 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Diagnosis of NAFLD or NASH - At least 2 doses of the COVID-19 Vaccine, per self report - Possession of a smartphone capable of running the Bt_NCBT-00x application - BMI >/= 30 at the screening visit - Fibroscan CAP >300 dB/m collected at screening visit - Completion of baseline MRI-PDFF - Understand written and spoken english Exclusion Criteria: - Inability to read and understand english - unstable or life-threatening medical illness - weight loss of greater than 10lbs within the last 90 days - pregnant or planning to become pregnant women - concurrent enrollment in any other interventional clinical trial - presumed or confirmed COVID-19 diagnosis within 30 days prior to study enrollment - change in medication regimen of hormonal contraceptives, anti-hyperglycemic medications, mental or emotional disorder medications, corticosteroids, thyroid hormones, Tamoxifen or Methotrexate within 90 days

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BT-NCBT-00X
the intervention group will consist of 20 patients to receive the BT-NCBT-00X treatment for 90 days. They will receive a baseline MRI-PDFF, Fibroscan and have the tests repeated at 90 days.

Locations

Country Name City State
United States Arizona Liver Health Chandler Arizona
United States Arizona Liver Health Peoria Arizona

Sponsors (2)

Lead Sponsor Collaborator
Better Therapeutics Arizona Liver Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in percent liver fat Mean change in percent liver fat from baseline to end of treatment in participants with baseline PDFF = 10%, as measured by MRI-PDFF. 90 days
Secondary Change in Liver Fat- all participants Mean change in liver fat from baseline to end of treatment in all participants, as measured by MRI-PDFF 90 days
Secondary Reduction in Percent Liver fat Percent of participants who achieve = 30% change in PDFF from baseline to end of treatment 90 days
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