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

NCT ID: NCT07100418

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HRS-7249 Group

Group Type EXPERIMENTAL

HRS-7249 Injection

Intervention Type DRUG

HRS-7249 injection.

Sodium Chloride Injection Group

Group Type PLACEBO_COMPARATOR

Sodium Chloride Injection

Intervention Type DRUG

Sodium chloride injection.

Interventions

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HRS-7249 Injection

HRS-7249 injection.

Intervention Type DRUG

Sodium Chloride Injection

Sodium chloride injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chanjuan Deng

Role: CONTACT

+86-0518-82342973

Facility Contacts

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Xumin Hou

Role: primary

+86-021-62801105

Other Identifiers

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HRS-7249-201

Identifier Type: -

Identifier Source: org_study_id

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