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NOT YET RECRUITING
NCT07878091
PHASE2

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

Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of Kylo-0603 Capsule in Study Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-11-15

Completion Date

2027-08-15

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

DRUG

Kylo 0603 Capsule 8mg

THR β agonist

DRUG

Kylo 0603 Capsule 12mg

THR β agonist

DRUG

Kylo 0603 Capsule 16mg

THR β agonist

DRUG

Kylo 0603 Capsule Placebo

Placebo

Locations (1)

Beijing Tsinghua Changgung Hospital, Affiliated to Tsinghua University

Beijing, Beijing Municipality, China