Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 17 of 17

List	Outcome	Time frame	Description
Primary	Part A: Maximum Observed Serum Concentration (Cmax) of Evinacumab	At day 12	Cmax was obtained directly from the plasma concentration versus time curve.
Primary	Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Evinacumab	Up to Week 12	AUClast was defined as area under the serum concentration time-curve from zero to the last measured concentration.
Primary	Part A: Terminal Half-Life (t1/2) of Evinacumab	Up to week 12	T1/2 was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.
Primary	Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24	Baseline to Week 24	Percent change was calculated as 100 multiplied by (calculated LDL-C value at Week 24 minus calculated LDL-C value at baseline) divided by calculated LDL-C value at baseline.
Secondary	Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Part A: up to Week 24; Part B: up to Week 48	Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAE was defined as AE starting/worsening after first intake of study drug. TEAE included participants with both serious and non-serious AEs. 1 participant experienced an AE during part B that was recorded after Part B database lock. This was not reflected in the reported endpoint number of participants of 10.
Secondary	Part B: Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 24	Baseline to Week 24	Percent change in Apo B from baseline to Week 24 was reported.
Secondary	Part B: Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 24	Baseline to Week 24	Percent change in Non-HDL-C from baseline to Week 24 was reported.
Secondary	Part B: Percent Change in Total Cholesterol (TC) From Baseline to Week 24	Baseline to Week 24	Percent change in TC from baseline to Week 24 was reported.
Secondary	Part B: Percentage of Participants With ≥50 Percent (%) Reduction in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24	Week 24	Percentage of participants who achieved reduction in calculated LDL-C ≥ 50% at Week 24 was reported.
Secondary	Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 in Participants Who Have Negative/Negative and Null/Null Mutations	Baseline to Week 24	Participants with HoFH was classified based on the phenotype of the Low-density lipoprotein receptor (LDLR) mutation(s), ranging from defective mutations (where the LDLR retains some LDL-binding functionality) to null or negative mutations where no functioning LDLR was expressed. Participants who have LDLR activity \<15% are considered null and participants whose LDLR activity was impaired but \>15% are LDLR defective. Percent change in calculated LDL-C from baseline to Week 24 in participants who have negative/negative and null/null mutations was reported.
Secondary	Part B: Percent Change in Lipoprotein A (Lp[a]) From Baseline to Week 24	Baseline to Week 24	Percent change in Lp(a) from baseline to Week 24 was reported.
Secondary	Part B: Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Week 24	Baseline, Week 24	Absolute change in LDL-C from baseline at Week 24 was reported
Secondary	Part B: Serum Concentration of Total Evinacumab	Pre-dose at Weeks 0, 4, 8, 12; End of infusion at Weeks 0.006, 4.006, 8.006, 12.006 and 24	Serum concentration of total evinacumab was reported. Pre-dose samples at week 0 were assayed and the reported value is based on actual measurement.
Secondary	Part B: Maximum Serum Concentration at Steady State (Cmax,ss) of Evinacumab	Post-dose up to day 169	Maximum serum concentration (Cmax,ss) steady state following drug administration.
Secondary	Part B: Area Under the Serum Concentration-time Curve at Steady State (AUCtau.ss) of Evinacumab	Post-dose up to day 169	AUCtau.ss was defined as area under the serum concentration-time curve at steady state of evinacumab
Secondary	Part B: Minimum Serum Concentration at Steady State (Ctrough.ss) of Evinacumab	Post-dose up to day 169	Ctrough.ss was defined as minimum serum concentration at steady state of evinacumab
Secondary	Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 in Participants Who Have by Null/Null vs. Non-null/Null and Negative/Negative vs.Non-negative/Negative Mutations	Baseline to Week 24

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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