NCT06820099

Study on the Efficacy and Safety of HRS-7535 in Patients With Mild Decrease in Ejection Fraction/Preserved Ejection Fraction Heart Failure and Obesity

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS-7535 in Subjects With Heart Failure, Mild Reduction/Preservation of Ejection Fraction, and Obesity

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel design phase II clinical trial, including a screening period of up to 2 weeks, a 36-weeks' treatment period, and a 1-week safety follow-up visit period.

Conditions

• Adults With Heart Failure, Mild Decrease in Ejection Fraction/Preserved Ejection Fraction, and Obesity

Interventions

Type	Name	Description
DRUG	HRS-7535 tablet	HRS-7535 tablet.
DRUG	HRS-7535 tablet placebo	HRS-7535 tablet placebo.

Timeline

• Start date: 2025-04-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-02-11
• Last updated: 2025-12-29

Locations

1 site across 1 country: China