MedTrace Logo

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

NCT07729475 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-27

No results posted yet for this study

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.

Conditions

  • Elevated Lipoprotein(a)

Interventions

DRUG

SAL0137 Dose 1

SAL0137 Tablets

DRUG

SAL0137 Dose 2

SAL0137 Tablets

DRUG

SAL0137 Dose 3

SAL0137 Tablets

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-27
Primary Completion
2026-12-12
Completion
2027-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729475 on ClinicalTrials.gov