NCT04774003: ORION-14

Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C

Completed Phase 1 Last updated 25 March 2025

What this trial tests

Phase 1 trial testing 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) in Hyperlipidemia in 40 participants. Completed in 18 October 2021.

Timeline

26 February 2021

Primary endpoint
18 October 2021

18 October 2021

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	26 February 2021
Primary completion	18 October 2021
Estimated completion	18 October 2021
Sites	3 locations across China

Drugs / interventions tested

• 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) — full drug profile →
• Placebo
• 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) — full drug profile →

Conditions studied

• Hyperlipidemia — all drugs for Hyperlipidemia →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Hyperlipidemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study to evaluate the pharmacokinetics and pharmacodynamics of inclisiran treatment given as single subcutaneous injection in Chinese participants with elevated low-density lipoprotein cholesterol (LDL-C) despite treatment with LDL-C lowering therapies

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting proprotein convertase subtilisin/kexin type 9 (PCSK9): from bench to bedside.
   Bao X, Liang Y, Chang H, Cai T, et al · · 2024 · cited 101× · PMID 38185721 · DOI 10.1038/s41392-023-01690-3
2. Inclisiran, Low-Density Lipoprotein Cholesterol and Lipoprotein (a).
   Katsiki N, Vrablik M, Banach M, Gouni-Berthold I. · · 2023 · cited 50× · PMID 37111334 · DOI 10.3390/ph16040577
3. Clinical potential of inclisiran for patients with a high risk of atherosclerotic cardiovascular disease.
   Nishikido T. · · 2023 · cited 28× · PMID 36717882 · DOI 10.1186/s12933-023-01752-4
4. The clinical effects of inclisiran, a first-in-class LDL-C lowering siRNA therapy, on the LDL-C levels in Chinese patients with hypercholesterolemia.
   Luo Z, Huang Z, Sun F, Guo F, et al · · 2023 · cited 23× · PMID 37164838 · DOI 10.1016/j.jacl.2023.04.010
5. RNA Silencing in the Management of Dyslipidemias.
   Henney NC, Banach M, Penson PE. · · 2021 · cited 23× · PMID 34468873 · DOI 10.1007/s11883-021-00968-7
6. Development of Novel siRNA Therapeutics: A Review with a Focus on Inclisiran for the Treatment of Hypercholesterolemia.
   Ebenezer O, Comoglio P, Wong GK, Tuszynski JA. · · 2023 · cited 21× · PMID 36835426 · DOI 10.3390/ijms24044019
7. Current RNA strategies in treating cardiovascular diseases.
   Chia SPS, Pang JKS, Soh BS. · · 2024 · cited 13× · PMID 38291757 · DOI 10.1016/j.ymthe.2024.01.028
8. Updates in Small Interfering RNA for the Treatment of Dyslipidemias.
   Carugo S, Sirtori CR, Gelpi G, Corsini A, et al · · 2023 · cited 13× · PMID 37792132 · DOI 10.1007/s11883-023-01156-5