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

Completed · Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT03938246

Run by

Sagimet Biosciences Inc.

People needed

142

Starts

2019-03-22

Expected to finish

2021-10-02

Last updated by the study team

2024-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 18 years with a body mass index (BMI) ≤40 kg/m2.
• 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.

You may not qualify if…

• Subjects meeting any of the following criteria are not eligible for enrollment in the study.
• 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.
• Type 1 diabetes.
• 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.
• Presence of cirrhosis on liver biopsy (Stage 4 fibrosis) or imaging.

Where it is running

• ProSciento — Chula Vista, California, United States
• Catalina Research Institute — Montclair, California, United States
• Clinical Trials Research — Sacramento, California, United States
• University of California San Diego (UCSD) — San Diego, California, United States
• Panax — Miami Lakes, Florida, United States
• Lucas Research — Morehead City, North Carolina, United States
• Texas Diabetes and Endocrinology - Austin — Austin, Texas, United States
• Texas Digestive Disease Consultants - Cedar Park — Cedar Park, Texas, United States
• Texas Digestive Disease Consultants - Dallas — Dallas, Texas, United States
• Texas Digestive Disease Consultant - Ft Worth — Fort Worth, Texas, United States
• Pinnacle Clinical Research - San Antonio — San Antonio, Texas, United States
• Texas Digestive Disease Consultants - Webster — Webster, Texas, United States
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Beijing YouAn Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Foshan First People's Hospital — Foshan, Guangdong, China
• Nanfang Hospital — Guangzhou, Guangdong, China
• The First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China
• The Third Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China
• The Second Hospital of Nanjing — Nanjing, Jiangsu, China
• Ruijin Hospital, Shanghai JiaoTong University School of Medicine — Shanghai, Shanghai Municipality, China
• Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine — Shanghai, Shanghai Municipality, China
• Shanghai Tongren Hospital, Shanghai JiaoTong University School of Medicine — Shanghai, Shanghai Municipality, China
• The Affiliated Hospital of Hangzhou Normal University — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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