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Hypercholesterolaemia

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Hypercholesterolaemia

7 trials tracked for Hypercholesterolaemia: 5 in phase 3 or 4 and 3 with published results. The most-cited published study has 139 citations.

7Trials tracked
5Phase 3 & 4
0Recruiting
3With published results
Phase distribution
Phase 4 1 Phase 3 4 Phase 2 1 Phase 1 1
  1. Phase 3 Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) Completed · 139 cited
  2. Phase 3 An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Completed · 37 cited
  3. Phase 3 Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy Completed · 8 cited
  4. Phase 4 Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels Completed
  5. Phase 3 Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) Completed
  6. Phase 2 An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Completed
Show 1 more trials
  1. Phase 1 Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020) Completed

Showing the 7 most-cited and recently-updated of 7 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Hypercholesterolaemia: what the trials found

Alirocumab has demonstrated significant reductions in calculated LDL-C levels across multiple trials. In a Phase 3 study, Alirocumab showed a reduction of 48.2% to 51.8% in LDL-C at week 24 (p<0.0001) 2. Another Phase 3 trial confirmed a reduction of 45.7% in LDL-C at week 24 (p<0.0001) 5. Additionally, Alirocumab SAR236553 (REGN727) showed significant reductions in LDL-C at week 24 (p<0.0001) 3 and week 8 (p<0.0001) 6.

Alirocumab SAR236553 (REGN727) also demonstrated a significant reduction in Apolipoprotein B (Apo B) at week 24 (p<0.0001) 3. In a Phase 2 study, Alirocumab SAR236553 (REGN727) showed a reduction in LDL-C at week 8 (p<0.0001), with a high percentage of participants achieving LDL-C levels below 130 mg/dL (3.37 mmol/L) 6.

Switching to a ritonavir-boosted PI was associated with a significant reduction in total cholesterol at 12 weeks (p=0.003) 1. Regarding administration safety, a study on Alirocumab SAR236553 reported a 0.5% rate of product technical complaints (PTCs) for unsupervised injections and 0% for supervised injections 4.

Recent results — preliminary, needs further review

  • Enlicitide Decanoate excretion was measured in a Phase 1 study, showing varying amounts of excreted substance and unchanged Enlicitide Decanoate in urine over 24 hours 7.

For the clinician treating this condition

  • Alirocumab and its variant Alirocumab SAR236553 (REGN727) consistently demonstrate significant reductions in LDL-C and Apolipoprotein B [2, 3, 5, 6].
  • Alirocumab SAR236553 (REGN727) showed high efficacy in achieving LDL-C targets below 130 mg/dL and 110 mg/dL in a Phase 2 trial 6.
  • Switching to a ritonavir-boosted PI is associated with a significant reduction in total cholesterol 1.

AI synthesis of 7 cited trials, updated Sep 17, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.