MedDataX Logo

Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

NCT ID: NCT03938246

Last Updated: 2024-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-22

Study Completion Date

2021-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

NASH Non-Alcoholic Steatohepatitis Fatty Liver Disease Fatty Liver Liver Diseases FASN Fatty Acid Synthase Inhibitor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomly assigned to experimental or placebo arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TVB-2640 25 mg (US)

Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours).

Group Type EXPERIMENTAL

TVB-2640 25 mg (US)

Intervention Type DRUG

Oral dose, tablet, daily dosing

TVB-2640 50 mg (US)

Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours).

Group Type EXPERIMENTAL

TVB-2640 50 mg (US)

Intervention Type DRUG

Oral dose, tablet, daily dosing

Placebo (US)

Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640.

Group Type PLACEBO_COMPARATOR

Placebo (US)

Intervention Type DRUG

Oral dose, tablet, daily dosing

TVB-2640 50 mg (China)

Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours).

Group Type EXPERIMENTAL

TVB-2640 50 mg (China)

Intervention Type DRUG

Oral dose, tablet, daily dosing

Placebo (China)

Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640.

Group Type PLACEBO_COMPARATOR

Placebo (China)

Intervention Type DRUG

Oral dose, tablet, daily dosing

TVB-2640 75 mg (US)

After completion of Cohorts 1 and 2, and if no stopping criteria are met upon review by the Independent SRC, an additional TVB-2640 75 mg open-label Cohort 3 will open in the US

Group Type EXPERIMENTAL

TVB-2640 75 mg (US)

Intervention Type DRUG

Oral dose, tablet, daily dosing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TVB-2640 25 mg (US)

Oral dose, tablet, daily dosing

Intervention Type DRUG

TVB-2640 50 mg (US)

Oral dose, tablet, daily dosing

Intervention Type DRUG

Placebo (US)

Oral dose, tablet, daily dosing

Intervention Type DRUG

TVB-2640 50 mg (China)

Oral dose, tablet, daily dosing

Intervention Type DRUG

Placebo (China)

Oral dose, tablet, daily dosing

Intervention Type DRUG

TVB-2640 75 mg (US)

Oral dose, tablet, daily dosing

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged ≥ 18 years with a body mass index (BMI) ≤40 kg/m2.
2. Prior liver biopsy within 24 months of randomization with fibrosis Stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

* Steatosis
* Ballooning degeneration
* Lobular inflammation

AND

* Confirmation of ≥ 8% liver fat content on MRI-PDFF.

OR, if prior biopsy is not available:

* Either overweight or obese or diabetic or ALT ≥ 30 U/L or fatty liver on ultrasound and at least one more feature of metabolic syndrome by Adult Treatment Panel III (ATP III) criteria.

AND

* Magnetic resonance elastography (MRE) ≥ 2.5 kPa and MRI-PDFF ≥ 8% during screening.

Exclusion Criteria

Subjects meeting any of the following criteria are not eligible for enrollment in the study.

1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.

Note: Significant alcohol consumption is defined as average of \> 20 g/day in female subjects and \> 30 g/day in male subjects.
2. Type 1 diabetes.
3. Uncontrolled Type 2 diabetes defined as:

* HbA1c ≥ 9.5% during screening. (Subjects with HbA1c ≥ 9.5% may be rescreened).
* Basal insulin dose adjustment \> 10% within 60 days prior to enrollment.
* Requirement for glucagon-like peptide analogue or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) within 6 months of screening.
* History of severe hypoglycemia (symptomatic hypoglycemia requiring outside assistance to regain normal neurologic status) within the previous year.

Note: Individual diabetes regimens will be reviewed by Investigator and may be adjusted based on American Diabetes Association guidelines.
4. Presence of cirrhosis on liver biopsy (Stage 4 fibrosis) or imaging.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sagimet Biosciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rohit Loomba, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ProSciento

Chula Vista, California, United States

Site Status

Catalina Research Institute

Montclair, California, United States

Site Status

Clinical Trials Research

Sacramento, California, United States

Site Status

University of California San Diego (UCSD)

San Diego, California, United States

Site Status

Panax

Miami Lakes, Florida, United States

Site Status

Lucas Research

Morehead City, North Carolina, United States

Site Status

Texas Diabetes and Endocrinology - Austin

Austin, Texas, United States

Site Status

Texas Digestive Disease Consultants - Cedar Park

Cedar Park, Texas, United States

Site Status

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, United States

Site Status

Texas Digestive Disease Consultant - Ft Worth

Fort Worth, Texas, United States

Site Status

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, United States

Site Status

Texas Digestive Disease Consultants - Webster

Webster, Texas, United States

Site Status

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Foshan First People's Hospital

Foshan, Guangdong, China

Site Status

Nanfang Hospital

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

The Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Site Status

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Tongren Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States China

References

Explore related publications, articles, or registry entries linked to this study.

Loomba R, Mohseni R, Lucas KJ, Gutierrez JA, Perry RG, Trotter JF, Rahimi RS, Harrison SA, Ajmera V, Wayne JD, O'Farrell M, McCulloch W, Grimmer K, Rinella M, Wai-Sun Wong V, Ratziu V, Gores GJ, Neuschwander-Tetri BA, Kemble G. TVB-2640 (FASN Inhibitor) for the Treatment of Nonalcoholic Steatohepatitis: FASCINATE-1, a Randomized, Placebo-Controlled Phase 2a Trial. Gastroenterology. 2021 Nov;161(5):1475-1486. doi: 10.1053/j.gastro.2021.07.025. Epub 2021 Jul 23.

Reference Type DERIVED
PMID: 34310978 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3V2640-CLIN-005

Identifier Type: -

Identifier Source: org_study_id