A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia
Recruiting
Phase 2
Interventional Study
Hyperlipidemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 189 (estimated)
- Sponsor
- Shandong Suncadia Medicine Co., Ltd. · Industry
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About This Trial
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.
Trial Locations
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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. …
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