Phase 2
N=142
Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
Bottom Line
View on ClinicalTrials.gov: NCT03938246 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline — -11.31; -27.59; 2.52; -28.68 percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- 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)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sagimet Biosciences Inc.
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline |
-11.31; -27.59; 2.52; -28.68; -15.63; -35.77 | — |
| SECONDARY Percentage of Subjects With at Least a 30% Reduction in Liver Fat at Week 12. |
7; 16; 3; 10; 2; 4 | — |
| SECONDARY Percentage of Change From Baseline in Alanine Aminotransferase (ALT) |
-2.98; -20.46; 6.82; -28.29; 14.06; -3.296 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03938246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.