Health TrialsbyHealthPanel

A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia

ConditionHyperlipidemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong Suncadia Medicine Co., Ltd.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female ≥ 18 years old, who is able and willing to provide a written informed consent

BMI ≥ 18.0 kg/m2

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

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

Disqualifiers

TG > 5.6 mmol/L

Diagnosed with homozygous familial hypercholesterolemia (HoFH)

Acute ischemic ASCVD events within 12 months before screening, or during the screening and run-in phase

Heart failure with New York Heart Association (NYHA) Class III-IV

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-1301

    Drug

    HRS-1301 Dose 1，oral

  • HRS-1301

    Drug

    HRS-1301 Dose 2，oral

  • HRS-1301

    Drug

    HRS-1301 Dose 3，oral

  • HRS-1301

    Drug

    HRS-1301 Dose 4，oral

  • Placebo

    Drug

    Placebo，oral

Treatment groups

189 Participants
are divided into 5 treatment groups
Group A: HRS-1301 Group AExperimental treatment 1 intervention
Group B: HRS-1301 Group BExperimental treatment 1 intervention
Group C: HRS-1301 Group CExperimental treatment 1 intervention
Group D: HRS-1301 Group DExperimental treatment 1 intervention
Group E: HRS-1301 Group EExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change in LDL-C relative to baseline

Time frame
at 12 weeks of treatment

Secondary outcomes

1

Proportion of subjects achieving LDL-C goals

Time frame
at 12 weeks of treatment
2

Percentage change in TC relative to baseline；

Time frame
at 12 weeks of treatment
3

Percentage change in HDL-C relative to baseline；

Time frame
at 12 weeks of treatment
4

Percentage change in TG relative to baseline；

Time frame
at 12 weeks of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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