Clinical Research Directory

A Phase 2a Study of Kylo-0603 Capsule in Participants With Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD)

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a metabolic stress-related liver injury closely associated with insulin resistance, with a global prevalence of approximately 25%. It may progress to metabolic dysfunction-associated steatohepatitis (MASH), which can lead to cirrhosis, end-stage liver disease, and increased cardiovascular risk, representing a major unmet medical need. Thyroid hormone receptor beta (THRβ) is predominantly expressed in the liver; selective agonism regulates hepatic lipid metabolism, reduces fat accumulation, suppresses hepatic inflammation and fibrosis, and may delay MASH progression. Kylo-0603 is a liver-targeted, highly selective THRβ agonist modified with GalNAc to enrich hepatic exposure and reduce peripheral effects. This multicenter, randomized, double-blind, placebo-controlled Phase 2a study will evaluate the efficacy, safety, and pharmacokinetics of once-daily oral Kylo-0603 capsules in approximately 120 participants with MASLD and overweight or obesity. Participants will be randomized 1:1:1:1 to Kylo-0603 8 mg, 12 mg, 16 mg, or placebo for 12 weeks. The primary endpoint is the percentage change from baseline in liver fat content assessed by MRI-PDFF at Week 12.

Vitamin E Versus Silymarin in Non Diabetic MASLD Patients

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), is a chronic liver condition marked by excessive fat buildup (steatosis) in liver cells, linked to at least one metabolic risk factor like obesity, type 2 diabetes, high blood lipids, or hypertension. Vitamin E serves as a recommended antioxidant therapy for select MASLD patients. It reduces liver inflammation markers such as ALT and AST, alongside benefits in steatosis and MASH resolution. Silymarin has clinical evidence supports its use as an adjunctive hepatoprotective agent due to antioxidant, anti-inflammatory, and antifibrotic effects.

Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients

This study aims to estimate the prevalence of Metabolic dysfunction - associated Steatoic liver disease (MASLD) among adults with primary hypothyroidism (overt or sub-clinical 1ry hypothyroidism) and prevalence of MASLD in Hashimoto-thyroiditis vs Euthyroid controls in non-diabetic patients.