Non-alcoholic SteatohepatitisNCT05357248
Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH
A study testing BT-NCBT-00X in people with Non-alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease, run by Better Therapeutics at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver
- What is being tested?
- BT-NCBT-00X
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2022to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arizona Liver Health
Chandler, Arizona, 85224
Arizona Liver Health
Peoria, Arizona, 85381
About this study
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.
Read the detailed 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.
- Conditions
- Non-alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver
- Being tested
- BT-NCBT-00X
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT-NCBT-00XDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention- BT-NCBT-00x | Experimental | 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. BT-NCBT-00x is accessed via the participants' smartphone after downloading from the phone's corresponding app store.
Participants will receive behavioral support by the Better Therapeutics patient services team in the form of phone calls as necessary or requested by the patient Receives: Device: BT-NCBT-00X |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (2)
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
Measured: 90 days
Reduction in Percent Liver fat
Percent of participants who achieve ≥ 30% change in PDFF from baseline to end of treatment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start10 Apr 2022
- Primary completion11 Nov 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single arm study of 20 patients is to evaluate the feasibility of using BT-NCBT-00x in the treatment of NAFLD and NASH
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Better Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arizona Liver Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357248
- Sponsor's protocol ID
- BT-NCBT-00x
- Status last verified
- Dec 2022
- First submitted
- 27 Apr 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Alkhouri N, Edwards K, Berman M, Finn H, Escandon R, Lupinacci P, Guthrie N, Coste A, Topete J, Noureddin M. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Adv. 2023 Oct 1;3(1):9-16. doi: 10.1016/j.gastha.2023.08.019. eCollection 2024.
PubMed 39132187
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH
- ClinicalTrials.gov ID
- NCT05357248
- Acronym / sponsor ID
- BT-NCBT-00x
- Conditions
- Non-alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Better TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Arizona Liver Health
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single arm study of 20 patients is to evaluate the feasibility of using BT-NCBT-00x in the treatment of NAFLD and NASH
| Arm | Type | Receives |
|---|---|---|
| Intervention- BT-NCBT-00x | Experimental | Device: BT-NCBT-00XThe 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. BT-NCBT-00x is accessed via the participants' smartphone after downloading from the phone's corresponding app store. Participants will receive behavioral support by the Better Therapeutics patient services team in the form of phone calls as necessary or requested by the patient |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT-NCBT-00Xthe 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. | Device | Intervention- BT-NCBT-00x |
Primary outcome
change in percent liver fat
Time frame: 90 days
Mean change in percent liver fat from baseline to end of treatment in participants with baseline PDFF ≥ 10%, as measured by MRI-PDFF.
2 secondary outcomes
Change in Liver Fat- all participants
Time frame: 90 days
Reduction in Percent Liver fat
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Derived from this study: PubMed 39132187Alkhouri N, Edwards K, Berman M, Finn H, Escandon R, Lupinacci P, Guthrie N, Coste A, Topete J, Noureddin M. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Adv. 2023 Oct 1;3(1):9-16. doi: 10.1016/j.gastha.2023.08.019. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BT-NCBT-00X in people with Non-alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease, run by Better Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in percent liver fat (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05357248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022; AzTrials last refreshed its copy on 1 Nov 2026.