NCT07229937 A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia
| NCT ID | NCT07229937 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. |
| Condition | Hyperlipidemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 189 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 189 participants in total. It began in 2025-11-25 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to explore the reasonable dosage of HRS-1301 in participants with dyslipidemia. The efficacy and safety of HRS-1301 will be evaluated after 12-weeks treatment.
Eligibility Criteria
Inclusion Criteria: 1. Male and female ≥ 18 years old, who is able and willing to provide a written informed consent 2. BMI ≥ 18.0 kg/m2 3. Clinically diagnosed with ASCVD and LDL-C ≥ 1.8 mmol/L OR, if no history of ASCVD, has intermediate to high risk of developing ASCVD and LDL-C ≥ 2.6 mmol/L 4. Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and for 2 weeks after the last dose, and agree to use contraceptive methods as specified in the protocol Exclusion Criteria: 1. TG \> 5.6 mmol/L 2. Diagnosed with homozygous familial hypercholesterolemia (HoFH) 3. Acute ischemic ASCVD events within 12 months before screening, or during the screening and run-in phase 4. Heart failure with New York Heart Association (NYHA) Class III-IV 5. Malignant tumors within 5 years 6. Received or is regularly receiving LDL or plasma apheresis within 12 months before screening 7. History or presence of severe gastrointestinal, hepatic, or renal diseases, or other known diseases that may interfere with drug absorption, distribution, metabolism, or excretion 8. Uncontrolled diabetes mellitus and/or hypertension 9. Has undergone transplantation of any vital organ, such as lung, liver, heart, bone marrow, or kidney
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07229937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hyperlipidemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07229937 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07229937 currently recruiting?
Yes, NCT07229937 is actively recruiting participants. Contact the research team at Miaomiao.shi@hengrui.com for enrollment information.
Where is the NCT07229937 trial being conducted?
This trial is being conducted at Harbin, China.
Who is sponsoring the NCT07229937 clinical trial?
NCT07229937 is sponsored by Shandong Suncadia Medicine Co., Ltd.. The trial plans to enroll 189 participants.