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StoppedReclassified as terminated (was completed)Sponsor's reason: Study has been terminated due to poor recruitment and early evidence of futilityShow 6 more changesShow less
Trial completed
Final enrollment: 30 participants (planned 48)
Primary completion date changed from estimate of Sep 15, 2026 to Jun 3, 2026
Eligibility criteria expanded, about 36 words
Study description revised
Site details revised at 4 of 4 sites
MinorSite details revised at 1 of 4 sitesv21
MinorSite details revised at 2 of 4 sitesv20
MinorStudy sites: 2 to 4v19
MinorPrimary and study completion dates: May 31, 2026 to Sep 15, 2026v18
Show 16 earlier versionsHide 16 earlier versions
NotablePrimary and study completion dates: May 31, 2025 to May 31, 2026
Eligibility criteria shortened, about 16 words
Study description revised
v17
NotablePrimary and study completion dates: Aug 1, 2024 to May 31, 2025v16
NotableStart date: May 15, 2021 to Jul 1, 2021
Primary and study completion dates: Jun 2024 to Aug 1, 2024
v15
MinorRe-verified, no change to tracked fieldsv14
MinorEligibility criteria shortened, about 9 wordsv13
NotablePrimary and study completion dates: Dec 2022 to Jun 2024
Site details revised at 2 of 2 sites
v12
MinorSite contacts updated at 1 of 2 sitesv11
MinorEligibility criteria shortened, about 64 wordsv10
MinorRe-verified, no change to tracked fieldsv9
MinorStudy description revisedv8
NotableTrial status: Suspended to Recruitingv7Show 5 more changesShow less
Start date: Apr 15, 2019 to May 15, 2021
Enrollment target: 60 to 48
Study sites: 1 to 2
Eligibility criteria expanded, about 40 words
Study description shortened, about 10 words
StoppedTrial status: Recruiting to SuspendedSponsor's reason: Recruitment has been halted until further funding is secured.
Primary completion date: Aug 2020 to Dec 2022
Study completion date: Dec 2020 to Dec 2022
Site details revised
v6
MinorRe-verified, no change to tracked fieldsv5
NotableStart date changed from estimate of Nov 2018 to Apr 15, 2019v4
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 1
v3
NotableStart date: Aug 2018 to Nov 2018
Primary endpoint revised
Eligibility criteria expanded, about 2 words
Study description shortened, about 1 word
v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Participants meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months. The primary goal for the trial is to determine if the investigators can recruit, randomize, and retain participants to perform invasive and non-invasive measurements of NASH and fibrosis, deliver lifestyle modification and demonstrate the safety of VSG. The investigators wish to also understand which of these two interventions is more effective in achieving, 12 months after entry into the trial, a reduction in NAS composed of the non-weighted scores: (1) steatosis 0-3 (2) Inflammation 0-3 and (3) ballooning 0-2. Secondary goals include comparing the two treatment groups for changes in other measured outcomes including MRI assessments of intrahepatic triglyceride and liver elasticity and serum markers. As a pilot study, a sample size of 20 in each group should offer significant information as to the difference in NAS score reduction between to two groups and achieve adequate power to distinguish clinically significant changes in the primary and secondary outcome measures. These data support the overarching objective i.e. to provide evidence that a larger, longer-term clinical outcomes trial is feasible. A goal is for a longer term follow up for 5 years to assess the durability of treatment effects and treatment differences.