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NOT YET RECRUITING
NCT07729475
PHASE2

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral SAL0137 in Adults With Elevated Lp(a) and Increased Risk of Cardiovascular Events

Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled Phase II trial evaluating the efficacy and safety of oral SAL0137 in adults with elevated Lp(a) and high cardiovascular risk. Participants will be randomized 1:1:1:1 to receive low-dose SAL0137, medium-dose SAL0137, high-dose SAL0137, or placebo for a treatment period of 12 weeks. The study assesses changes in Lp(a) levels and safety parameters.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Oral SAL0137 Tablets in Adult Patients With Elevated Lipoprotein(a) and Increased Risk of Cardiovascular Events

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-07-27

Completion Date

2027-04-30

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

DRUG

SAL0137 Dose 1

SAL0137 Tablets

DRUG

SAL0137 Dose 2

SAL0137 Tablets

DRUG

SAL0137 Dose 3

SAL0137 Tablets

DRUG

Placebo

Placebo

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China