Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Public ClinicalTrials.gov record NCT03938246. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (FASCINATE-1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. Subjects will be randomly assigned to 1 of 2 treatment groups (TVB-2640 at one of three doses or placebo). Following randomization, subjects will begin the 12-week treatment period and will receive once daily TVB-2640 or placebo.
Study identification
- NCT ID
- NCT03938246
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 142 participants
Conditions and interventions
Interventions
- TVB-2640 25 mg (US) Drug
- TVB-2640 50 mg (US) Drug
- Placebo (US) Drug
- TVB-2640 50 mg (China) Drug
- Placebo (China) Drug
- TVB-2640 75 mg (US) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 22, 2019 (Actual)
- Primary completion
- Oct 2, 2021 (Actual)
- Completion
- Oct 2, 2021 (Actual)
- Last update posted
- Dec 19, 2024
2019 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 4
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ProSciento | Chula Vista | California | 91911 | — |
| Catalina Research Institute | Montclair | California | 91763 | — |
| Clinical Trials Research | Sacramento | California | 95821 | — |
| University of California San Diego (UCSD) | San Diego | California | 92037 | — |
| Panax | Miami Lakes | Florida | 33014 | — |
| Lucas Research | Morehead City | North Carolina | 28557 | — |
| Texas Diabetes and Endocrinology - Austin | Austin | Texas | 78749 | — |
| Texas Digestive Disease Consultants - Cedar Park | Cedar Park | Texas | 78613 | — |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 75246 | — |
| Texas Digestive Disease Consultant - Ft Worth | Fort Worth | Texas | 76104 | — |
| Pinnacle Clinical Research - San Antonio | San Antonio | Texas | 78229 | — |
| Texas Digestive Disease Consultants - Webster | Webster | Texas | 77598 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03938246, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 19, 2024 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03938246 live on ClinicalTrials.gov.