NCT01443650: Alirocumab formulation and tolerability study

NCT01443650 is a completed phase I alirocumab formulation/tolerability study, not a cardiovascular-event trial. The registered population comprised 36 healthy-eligible adults aged 18–65 with LDL cholesterol above 100 mg/dL. Randomized, double-masked groups received one subcutaneous injection of formulation A, one of formulation B, or two of formulation A. 1 2

The main question was whether the formulations differed in local tolerability: injection-site pain, redness and swelling were assessed over 15 days. Pharmacokinetics, LDL-cholesterol changes and adverse events were secondary measurements through approximately 85 days. Thus, this record is particularly relevant to formulation development, injection experience and early drug exposure. 2

Regeneron's own trial page independently identifies the protocol as a single-subcutaneous-dose safety, tolerability and pharmacology study. Neither that summary nor the inspected registration supplies a verified numerical between-formulation result here. NCT01448239 is a separate protocol, not a duplicate results source. 3

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT01443650. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT01443650. Original registration; establishes the exact study identity and registered methods.

2. ICH GCP — ICH GCP — NCT01443650. Readable reproduction of the sponsor-submitted registration, including the design and dated status fields; not an independent outcome study.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.

3. Regeneron — Regeneron — NCT01443650, official sponsor trial page. Confirms the single-dose alirocumab study identity and objectives.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.