Not a traditional drug phase: Glycine for Metabolic Dysfunction Associated Fatty Liver Disease
This study aims to investigate abnormalities in glycine-dependent metabolic pathways in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and evaluate whether dietary glycine supplementation improves liver health and metabolic function. The first is a cross-sectional case-control study comparing urinary acylglycine concentrations and other glycine-dependent metabolic parameters between 60 participants with MASLD and 30 healthy controls.
Official registry: https://clinicaltrials.gov/study/NCT07285135 · Singapore General Hospital · enrollment listed as 90
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Glycine, or Placebo. The registry lists allocation as randomized. This study aims to investigate abnormalities in glycine-dependent metabolic pathways in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and evaluate whether dietary glycine supplementation improves liver health and metabolic function.
They plan to enroll about 90 people at Singapore. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Investigating the Effects of Dietary Glycine Supplementation in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
Interventions: Glycine, Placebo
Primary outcome (registry wording): Difference in urinary acylglycine concentrations between MASLD participants and healthy controls
Who it is for (from inclusion criteria)
- Ages 21 Years to 70 Years
- Hepatic steatosis on MRI
- Absence of hepatic steatosis on MRI
- body-mass index (BMI) of 18.5-24.9 kg/m2
- No long-term medications
Who the registry excludes
- Uncontrolled diabetes (HbA1c \> 8%)
- Type 1 Diabetes Mellitus
- Clinically significant anemia (Haemoglobin \< 10 g/dL)
- Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis
- Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
- Glomerular filtration rate (GFR \< 30 ml/min)
- Serum alanine transaminase (ALT) \> 3x upper limit of normal (ULN)
Public study contact (from the registry)
Hong Chang Tan, MD PhD
tan.hong.chang@singhealth.com.sg
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Singapore General Hospital — Singapore, Singapore, Singapore (recruiting)
FAQ about this NCT record
Is NCT07285135 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07285135?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07285135?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary