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OpenTrials
Active, Not Recruiting

NCT Number: NCT07100418

A Clinical Study Evaluating the Efficacy and Safety of HRS-7249 in Treating Patients With Hyperlipidemia

The study is being conducted to evaluate the efficacy and safety of HRS-7249 for patients with hyperlipidemia, and to explore the reasonable dosage of HRS-7249 for patients with hyperlipidemia.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to provide a written informed consent.
  • Age ≥ 18 years old and < 80 years old.
  • Male or female.

Exclusion criteria

  • Acute pancreatitis within 3 months or within 4 weeks or planned for plasma exchange treatment.
  • Malignant tumors within 5 years.
  • Severe cardiovascular or cerebrovascular diseases.
  • Severe trauma or surgery within 6 months or severe infection within 3 months.
  • Previous diagnosed diseases affecting lipid levels.
  • Patients with unstable or severe diseases assessed as at risk by the investigator.
  • Uncontrolled hypertension.
  • Weight loss within 2 months or planned surgery causing unstable weight.
  • Uncontrolled diabetes.
  • Combined hyperthyroidism or hypothyroidism.
  • History of drug or alcohol abuse.
  • Significantly abnormal liver or kidney function.
  • Significantly abnormal blood routine.
  • Significantly abnormal thyroid function.
  • Participated in clinical research within 3 months.
  • Pregnant or lactating women, or refusing contraception.

Treatment and study plan

HRS-7249 Injection

Drug

HRS-7249 injection.

sodium chloride injection

Drug

Sodium chloride injection.

Primary outcomes

  1. The level of triglyceride (TG)

    Time frame: About 28 weeks.

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: About 48 weeks.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS-7249 in Patients With Hyperlipidemia

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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