Status:
COMPLETED
Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hyperlipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study to evaluate the pharmacokinetics and pharmacodynamics of inclisiran treatment given as single subcutaneous injection in Chinese participants with elevated low-density lipoprotein cholesterol (LD...
Detailed Description
The purpose of the study is to characterize pharmacokinetics, pharmacodynamics, safety and tolerability of inclisiran in Chinese participants with elevated serum LDL-C to support inclisiran registrati...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained before any assessment is performed.
- Male or female participants ≥ 18 years of age at screening
- Participants should meet fasting serum LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L) at screening
- Participants should meet fasting triglyceride \< 400 mg/dL (\< 4.52 mmol/L) at screening
- Participants should be receiving a maximally tolerated dose of statin#.
- For all participants, all the lipid-lowering therapy/ies (such as but not limited to statins and/or ezetimibe) should have remained stable (stable dose and no medication change) for ≥ 30 days before screening with no planned medication or dose change during study participation. #Maximum tolerated dose was defined as the maximum dose of statin that could be taken on a regular basis without intolerable AEs.
- Participants not receiving statin must have a documented evidence of intolerance to all doses of at least 2 different statins (or the corresponding local definition of complete intolerance to statins)
Exclusion
- Participants diagnosed with any of following: homozygous familial hypercholesterolemia, New York Heart Association class III \& IV heart failure, Type 2 diabetes, severe hypertension, active liver disease, HIV infection or any uncontrolled or serious disease;
- History of drug abuse or unhealthy alcohol use, malignancy of any organ system, or or allergy to the investigational compound/compound class;
- Major adverse cardiovascular event within 3 months prior to randomization;
- Calculated glomerular filtration rate ≤30 mL/min by estimated glomerular filtration rate (eGFR) using standardized clinical methodology;
- Use of other investigational drugs or planned use of other investigational products or devices;
- Women of child-bearing potential unless they are using basic methods of contraception during dosing of investigational drug (total abstinence, sterilization, barrier methods, hormonal contraception, intrauterine device);
- Treatment with monoclonal antibodies inhibiting PCSK9 within 90 days prior to screening.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04774003
Start Date
February 26 2021
End Date
October 18 2021
Last Update
March 25 2025
Active Locations (3)
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1
Novartis Investigative Site
Changsha, Hunan, China, 410003
2
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
3
Novartis Investigative Site
Beijing, China, 100029