A Phase 2 interventional study of TVB-2640 25 mg (US) and TVB-2640 50 mg (US) in MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), sponsored by Sagimet Biosciences Inc.. Completed at 23 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Sagimet Biosciences Inc. · Phase 2, Interventional, and Treatment
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 142 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Sagimet Biosciences Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
AND
OR, if prior biopsy is not available:
AND
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.
Uncontrolled Type 2 diabetes defined as:
Note: Individual diabetes regimens will be reviewed by Investigator and may be adjusted based on American Diabetes Association guidelines.
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).
Drug: 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).
Drug: TVB-2640 50 mg (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.
Drug: Placebo (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).
Drug: TVB-2640 50 mg (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.
Drug: Placebo (China)
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
Drug: TVB-2640 75 mg (US)
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Oral dose, tablet, daily dosing
Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline
As determined by MRI-PDFF
Time frame: 12 weeks
Percentage of Subjects With at Least a 30% Reduction in Liver Fat at Week 12.
As determined by MRI-PDFF
Time frame: 12 weeks
Percentage of Change From Baseline in Alanine Aminotransferase (ALT)
Time frame: 12 weeks
| Milestone | TVB-2640 25 mg (US) | TVB-2640 50 mg (US) | Placebo (US) | TVB-2640 50 mg (China) | Placebo (China) | TVB-2640 75 mg (US) |
|---|---|---|---|---|---|---|
| Started | 33 | 35 | 31 | 21 | 9 | 13 |
| Completed | 27 | 30 | 31 | 20 | 9 | 11 |
| Not completed | 6 | 5 | 0 | 1 | 0 | 2 |
As determined by MRI-PDFF
| percent change from baseline | TVB-2640 25 mg (US) | TVB-2640 50 mg (US) | Placebo (US) | TVB-2640 50 mg (China) | Placebo (China) | TVB-2640 75 mg (US) |
|---|---|---|---|---|---|---|
| Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline | -11.31 ± 29.837 | -27.59 ± 28.354 | 2.52 ± 33.030 | -28.68 ± 22.265 | -15.63 ± 30.789 | -35.77 ± 23.736 |
As determined by MRI-PDFF
| Participants | TVB-2640 25 mg (US) | TVB-2640 50 mg (US) | Placebo (US) | TVB-2640 50 mg (China) | Placebo (China) | TVB-2640 75 mg (US) |
|---|---|---|---|---|---|---|
| Percentage of Subjects With at Least a 30% Reduction in Liver Fat at Week 12. | 7 | 16 | 3 | 10 | 2 | 4 |
| percentage of change | TVB-2640 25 mg (US) | TVB-2640 50 mg (US) | Placebo (US) | TVB-2640 50 mg (China) | Placebo (China) | TVB-2640 75 mg (US) |
|---|---|---|---|---|---|---|
| Percentage of Change From Baseline in Alanine Aminotransferase (ALT) | -2.98 ± 38.443 | -20.46 ± 25.935 | 6.82 ± 37.258 | -28.29 ± 34.495 | 14.06 ± 79.621 | -3.296 ± 42.5397 |
Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TVB-2640 25 mg (US) | 0/33 (0%) | 0/33 (0%) | 25/33 (75.8%) |
| TVB-2640 50 mg (US) | 0/35 (0%) | 0/35 (0%) | 14/35 (40%) |
| Placebo (US) | 0/31 (0%) | 0/31 (0%) | 12/31 (38.7%) |
| TVB-2640 50 mg (China) | 0/21 (0%) | 0/21 (0%) | 17/21 (81%) |
| Placebo (China) | 0/9 (0%) | 0/9 (0%) | 5/9 (55.6%) |
| TVB-2640 75 mg (US) | 0/13 (0%) | 0/13 (0%) | 9/13 (69.2%) |
| Event | TVB-2640 25 mg (US) | TVB-2640 50 mg (US) | Placebo (US) | TVB-2640 50 mg (China) | Placebo (China) | TVB-2640 75 mg (US) |
|---|---|---|---|---|---|---|
| Dry EyeEye disorders | 1/33 | 1/35 | 1/31 | 8/21 | 2/9 | 5/13 |
| Skin exfoliationSkin and subcutaneous tissue disorders | 0/33 | 0/35 | 0/31 | 7/21 | 0/9 | 0/13 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 0/33 | 0/35 | 0/31 | 3/21 | 0/9 | 3/13 |
| Diffuse alopeciaSkin and subcutaneous tissue disorders | 0/33 | 0/35 | 0/31 | 0/21 | 0/9 | 3/13 |
| HeadacheNervous system disorders | 4/33 | 2/35 | 2/31 | 0/21 | 0/9 | 2/13 |
| Abdominal distensionGastrointestinal disorders | 2/33 | 0/35 | 1/31 | 0/21 | 0/9 | 2/13 |
| ConstipationGastrointestinal disorders | 1/33 | 1/35 | 1/31 | 0/21 | 0/9 | 2/13 |
| Upper respiratory tract infectionInfections and infestations | 2/33 | 2/35 | 1/31 | 3/21 | 1/9 | 0/13 |
| AsthenopiaEye disorders | 0/33 | 0/35 | 0/31 | 0/21 | 1/9 | 0/13 |
| Conjunctival depositEye disorders | 0/33 | 0/35 | 0/31 | 0/21 | 1/9 | 0/13 |
The overall number of participants that are provided here are as per safety population. Note- The Safety Population consisted of all randomized subjects who received at least 1 dose of study drug. Analysis is based on randomized treatment group.
| Age, Categorical(Participants) | TVB-2640 25 mg (US) | TVB-2640 50 mg (US) | Placebo (US) | TVB-2640 50 mg (China) | Placebo (China) | TVB-2640 75 mg (US) | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 29 | 27 | 19 | 8 | 12 | 122 |
| >=65 years | 6 | 6 | 4 | 2 | 1 | 1 | 20 |
| Sex: Female, Male(Participants) | TVB-2640 25 mg (US) | TVB-2640 50 mg (US) | Placebo (US) | TVB-2640 50 mg (China) | Placebo (China) | TVB-2640 75 mg (US) | Total |
|---|---|---|---|---|---|---|---|
| Female | 15 | 13 | 17 | 4 | 3 | 5 | 57 |
| Male | 18 | 22 | 14 | 17 | 6 | 8 | 85 |
| Ethnicity (NIH/OMB)(Participants) | TVB-2640 25 mg (US) | TVB-2640 50 mg (US) | Placebo (US) | TVB-2640 50 mg (China) | Placebo (China) | TVB-2640 75 mg (US) | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 22 | 24 | 25 | 0 | 0 | 13 | 84 |
| Not Hispanic or Latino | 11 | 11 | 6 | 21 | 9 | 0 | 58 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | TVB-2640 25 mg (US) | TVB-2640 50 mg (US) | Placebo (US) | TVB-2640 50 mg (China) | Placebo (China) | TVB-2640 75 mg (US) | Total |
|---|---|---|---|---|---|---|---|
| United States | 33 | 35 | 31 | 0 | 0 | 13 | 112 |
| China | 0 | 0 | 0 | 21 | 9 | 0 | 30 |
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Sagimet Biosciences Inc.