HyperlipidemiaPhase 2NCT07100418
A Clinical Study Evaluating the Efficacy and Safety of HRS-7249 in Treating Patients With Hyperlipidemia
A Phase 2 study testing HRS-7249 Injection and Sodium Chloride Injection in people with Hyperlipidemia, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- HRS-7249 Injection and Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2025to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent.
- Age ≥ 18 years old and < 80 years old.
- Male or female.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS-7249 in 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.
- Conditions
- Hyperlipidemia
- Being tested
- HRS-7249 Injection, Sodium Chloride Injection
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7249 InjectionDrug
HRS-7249 injection.
Sodium Chloride InjectionDrug
Sodium chloride injection.
| Study group | Role | What they receive |
|---|---|---|
| HRS-7249 Group | Experimental | Not described Receives: Drug: HRS-7249 Injection |
| Sodium Chloride Injection Group | Placebo comparator | Not described Receives: Drug: Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of triglyceride (TG)
Measured: About 28 weeks.
Secondary outcomes (1)
Adverse events (AEs)
Measured: About 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start12 Aug 2025
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100418
- Sponsor's protocol ID
- HRS-7249-201
- Status last verified
- Sep 2025
- First submitted
- 27 Jul 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS-7249 in Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT07100418
- Acronym / sponsor ID
- HRS-7249-201
- Conditions
- Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-7249 Group | Experimental | Drug: HRS-7249 Injection |
| Sodium Chloride Injection Group | Placebo comparator | Drug: Sodium Chloride Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able and willing to provide a written informed consent.
- Age ≥ 18 years old and < 80 years old.
- Male or female.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-7249 InjectionHRS-7249 injection. | Drug | HRS-7249 Group |
| Sodium Chloride InjectionSodium chloride injection. | Drug | Sodium Chloride Injection Group |
Primary outcome
The level of triglyceride (TG)
Time frame: About 28 weeks.
1 secondary outcome
Adverse events (AEs)
Time frame: About 48 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-7249 Injection and Sodium Chloride Injection in people with Hyperlipidemia, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of triglyceride (TG) (time frame: About 28 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.