NCT05888103CompletedPhase 3
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
A 6 Month Randomized, Double-blind, Placebo-controlled Study Followed by a 6 Month Open- Label Extension to Assess the Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not on any lipid lowering therapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 207 (actual)
- First submitted
- 24 May 2023
- Start date
- 11 Jul 2023
- Primary completion date
- 2 Apr 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05888103
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 207
- From 11 Jul 2023 to the primary completion date, 2 Apr 2024
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any LLT within 90 days prior to screening visit
Other illness
- History of ASCVD
- Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
- Other protocol-defined inclusion/exclusion criteria may apply.
Lab values
- Diabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
Who the study is looking for
- Written informed consent must be obtained before any assessment is performed.
- Fasting LDL-C of ≥ 130 mg/dL but \< 190 mg/dL
- Triglycerides ≤ 400 mg/dL
- Categorized as low or moderate ASCVD risk by the 2016 Chinese Guideline
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.