Drug Trials Snapshots: LEROCHOL
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the LEROCHOL Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
LEROCHOL (lerodalcibep-liga)
leer-O-call
LIB Therapeutics
Approval date: December 12, 2025
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms or VMS) due to menopause.
How is this drug used?
LEROCHOL is a prescription medicine (proprotein convertase subtilisin kexin type 9 [PCSK9] inhibitor) that is used as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
How is this drug used?
LEROCHOL is a subcutaneous injection that is taken once monthly.
Who participated in the clinical trials?
The FDA approved LEROCHOL based on evidence from two clinical trials of 1,844 adults with atherosclerotic cardiovascular disease (ASCVD) or at increased risk for ASCVD events (Trial 1, NCT04797247; Trial 2, NCT04806893), and a single trial of 478 patients with heterozygous familial hypercholesterolemia (HEFH) (Trial 3; NCT04797104). The trials were conducted at 65 sites in 11 countries, including the United States, Canada, Germany, Spain, India, New Zealand, United Kingdom, South Africa, Norway, Israel, and Turkey.
The benefits and side effects of LEROCHOL for patients with ASCVD or at increased for risk for ASCVD events and HeFH were evaluated in the same trials.All trials enrolled patients who were already using other treatments to lower LDL-C, including a low-fat, low-cholesterol diet and a maximally tolerated dose of statin with or without other lipid lowering medications. Patients in all three trials were randomly assigned to receive LEROCHOL or placebo every four weeks. Patients in Trials 1 and 2 received LEROCHOL or placebo for one year, and patients in Trial 3 received LEROCHOL or placebo for 24 weeks. Neither the patients nor the health care providers knew which treatment was being given.
How were the trials designed?
All trials enrolled patients who were already using other treatments to lower LDL-C, including a low-fat, low-cholesterol diet and a maximally tolerated dose of statin with or without other lipid lowering medications. Patients in all three trials were randomly assigned to receive LEROCHOL or placebo every four weeks. Patients in Trials 1 and 2 received LEROCHOL or placebo for one year, and patients in Trial 3 received LEROCHOL or placebo for 24 weeks. Neither the patients nor the health care providers knew which treatment was being given.
All three trials measured percent change in LDL-C from baseline (before treatment) to end of treatment (52 weeks for Trials 1 and 2; 24 weeks for Trial 3) and compared LEROCHOL to placebo.
How were the trials designed?
The efficacy of LEROCHOL was demonstrated in two randomized, placebo-controlled, double-blind clinical trials (Trial 1, NCT04797247; Trial 2, NCT04806893) in adult patients with ASCVD or at increased risk of ASCVD with LDL-C ≥70 mg/dL and triglyceride ≤400 mg/dL while on stable lipid-lowering oral drug therapy. Patients were stable on a low-fat, low-cholesterol diet, maximally tolerated dose of statin with or without other oral lipid modifying therapy. Patients were randomly assigned to receive doses every four weeks of LEROCHOL 300 mg (n=1,229) or placebo (n=615) via subcutaneous injection over a 52-week treatment period. The primary endpoint was percent change in LDL-C from baseline to Week 52 in patients receiving LEROCHOL compared to placebo.
The efficacy of LEROCHOL in adult patients with HEFH was demonstrated in one randomized, placebo-controlled, double-blind clinical trial (Trial 3; NCT04797104). Patients were stable on diet, maximally tolerated dose of statin, with or without other oral lipid modifying therapy. Patients were randomly assigned to receive doses every four weeks of LEROCHOL 300 mg (n=319) or placebo (n=159) via subcutaneous injection over a 24-week treatment period. The primary endpoint was percent change in LDL-C from baseline to Week 24 in patients receiving LEROCHOL compared to placebo.
DEMOGRAPHICS SNAPSHOT
Atherosclerotic Cardiovascular Disease
Figure 1 summarizes how many male and female ASCVD patients were enrolled in the combined clinical trials used to evaluate the efficacy of LEROCHOL.
Figure 1. Baseline Demographics by Sex for ASCVD Patients, Trials 1 & 2, Efficacy Population
Source: Adapted from FDA Review
Abbreviations: ASCVD, atherosclerotic cardiovascular disease
Figure 2 summarizes how many ASCVD patients by race were enrolled in the combined clinical trials used to evaluate the efficacy of LEROCHOL.
Figure 2. Baseline Demographics by Race for ASCVD Patients, Trials 1 & 2, Efficacy Population
Source: Adapted from FDA Review
Abbreviations: ASCVD, atherosclerotic cardiovascular disease
Figure 3 summarizes how many ASCVD patients by age were enrolled in the combined clinical trials used to evaluate the efficacy of LEROCHOL.
Figure 3. Baseline Demographics by Age for ASCVD Patients, Trials 1 & 2, Efficacy Population
Source: Adapted from FDA Review
Abbreviations: ASCVD, atherosclerotic cardiovascular disease
Figure 4 summarizes how many ASCVD patients by ethnicity were enrolled in the combined clinical trials used to evaluate the efficacy of LEROCHOL.
Figure 4. Baseline Demographics by Ethnicity for ASCVD Patients, Trials 1 & 2, Efficacy Population
Source: Adapted from FDA Review
Abbreviations: ASCVD, atherosclerotic cardiovascular disease
Figure 5 summarizes how many male and female HeFH patients were enrolled in the clinical trial used to evaluate the efficacy of LEROCHOL.
Figure 5. Baseline Demographics by Sex for HeFH Patients, Trial 3, Efficacy Population
Source: Adapted from FDA Review
Abbreviations: HeFH, heterozygous familial hypercholesterolemia
Figure 6 summarizes how many HeFH patients by race were enrolled in the clinical trial used to evaluate the efficacy of LEROCHOL.
Figure 6. Baseline Demographics by Race for HeFH Patients, Trial 3, Efficacy Population
Figure 7 summarizes how many HeFH patients by age were enrolled in the clinical trial used to evaluate the efficacy of LEROCHOL.
Figure 7. Baseline Demographics by Age for HeFH Patients, Trial 3, Efficacy Population
Source: Adapted from FDA Review
Abbreviations: HeFH, heterozygous familial hypercholesterolemia
Figure 8 summarizes how many HeFH patients by ethnicity were enrolled in the clinical trial used to evaluate the efficacy of LEROCHOL.
Figure 8. Baseline Demographics by Ethnicity for HeFH Patients, Trial 3, Efficacy Population
Source: Adapted from FDA Review
Abbreviations: HeFH, heterozygous familial hypercholesterolemia
Who participated in the trials?
Table 1. Baseline Demographics by Subgroup, Efficacy Trials
Baseline Demographics |
Trial 1, N=922 |
Trial 2, N=922 |
Trial 3, N=478 |
|||
|---|---|---|---|---|---|---|
|
LEROCHOL n=614 |
Placebo n=308 |
LEROCHOL n=615 |
Placebo n=307 |
LEROCHOL n=319 |
Placebo n=159 |
|
Sex, n (%) |
|
|
|
|
|
|
Female |
184 (30.0) |
92 (29.9) |
281 (45.7) |
133 (43.3) |
164 (51.4) |
83 (52.2) |
Male |
430 (70.0) |
216 (70.1) |
334 (54.3) |
174 (56.7) |
155 (48.6) |
76 (47.8) |
Age, years |
|
|
|
|
|
|
Mean (SD) |
63.3 (10.7) |
64.9 (10.0) |
64.6 (9.5) |
64.5 (9.4) |
52.5 (12.5) |
53.8 (12.3) |
Minimum, maximum |
26, 90 |
25, 89 |
27, 84 |
28, 87 |
19, 80 |
18. 79 |
Age category, years, n (%) |
|
|
|
|
|
|
<65 |
328 (53.4) |
140 (45.5) |
281 (45.7) |
143 (46.6) |
259 (81.2) |
130 (81.8) |
≥65 |
286 (46.6) |
168 (54.5) |
334 (54.3) |
164 (53.4) |
60 (18.8) |
29 (18.2) |
Race, n (%) |
|
|
|
|
|
|
White |
491 (80.0) |
242 (78.6) |
485 (78.9) |
234 (76.2) |
273 (85.6) |
143 (89.9) |
Black or African American |
102 (16.6) |
56 (18.2) |
108 (17.6) |
58 (18.9) |
25 (7.8) |
12 (7.5) |
Asian |
21 (3.4) |
9 (2.9) |
20 (3.3) |
15 (4.9) |
21 (6.6) |
4 (2.5) |
American Indian or Alaska Native |
0 (0.0) |
0 (0.0) |
1 (0.2) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
Native Hawaiian or other Pacific Islander |
0 (0.0) |
1 (0.3) |
1 (0.2) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
Ethnicity, n (%) |
|
|
|
|
|
|
Hispanic or Latino |
6 (1.0) |
4 (1.3) |
77 (12.5) |
45 (14.7) |
2 (0.6) |
2 (1.3) |
Not Hispanic or Latino |
604 (98.4) |
302 (98.1) |
535 (87.0) |
259 (84.4) |
315 (98.8) |
157 (98.7) |
Unknown |
4 (0.7) |
2 (0.7) |
3 (0.5) |
3 (1.0) |
2 (0.6) |
0 (0.0) |
Source: Adapted from FDA Review
Abbreviations: SD, standard deviation
What are the benefits of this drug?
In Trial 1 and 2, patients who received LEROCHOL had a 55% reduction and a 50% reduction (respectively) in LDL-C compared to patients who received placebo after 52 weeks of treatment.
In Trial 3, patients with HEFH who received LEROCHOL had a 59% reduction in LDL-C compared to patients who received placebo after 24 weeks of treatment.
What are the benefits of this drug (results of trials
Efficacy results from each trial are presented in Table 2, Table 3, and Table 4. The primary endpoint was the mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to the primary analysis time point.
Table 2. Percent Change in LDL-C from Baseline at Week 52, Trial 1
Parameter |
LEROCHOL N=614 LS Mean |
Placebo N=308 LS Mean |
Difference (95% CI) |
|---|---|---|---|
Change in LDL-C from Baseline at Week 52, % |
-55 |
-0.1 |
-55 (-59, -51) |
Source: Adapted from LEROCHOL Prescribing Information
Abbreviations: CI, confidence interval; LDL-C, low-density lipoprotein cholesterol; LS mean, least-squares mean; N, total number of subjects
Table 3. Percent Change in LDL-C from Baseline at Week 52, Trial 2
Parameter |
LEROCHOL N=615 LS Mean |
Placebo N=307 LS Mean |
Difference (95% CI) |
|---|---|---|---|
Change in LDL-C from Baseline at Week 52, % |
-49 |
0.3 |
-50 (-54, -45) |
Source: Adapted from LEROCHOL Prescribing Information
Abbreviations: CI, confidence interval; LDL-C, low-density lipoprotein cholesterol; LS mean, least-squares mean; N, total number of subjects
Table 4. Percent Change in LDL-C from Baseline at Week 24, Trial 3
Parameter |
LEROCHOL N=319 LS Mean |
Placebo N=159 LS Mean |
Difference (95% CI) |
|---|---|---|---|
Change in LDL-C from Baseline at Week 24, % |
-51 |
8 |
-59 (-66, -52) |
Source: Adapted from LEROCHOL Prescribing Information
Abbreviations: CI, confidence interval; LDL-C, low-density lipoprotein cholesterol; LS mean, least-squares mean; N, total number of subjects
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: The effect of LEROCHOL was similar for females and males.
- Race: The observed effect of LEROCHOL was similar regardless of race.
- Age: The observed effect of LEROCHOL was similar regardless of whether patients were younger or older than 65 years of age.
Table 5. Percent Change in LDL-C From Baseline at Week 52 by Subgroup, Trial 1, Efficacy Population
Group |
Subgroup |
LS Mean (95% CI)* |
|---|---|---|
Sex |
Female |
-54.8 (-59.8, -49.9) |
Male |
-55.0 (-59.4, -50.7) |
|
Age, years |
<65 |
-55.5 (-60.1, -50.8) |
≥65 |
-55.1 (-59.8, -50.6) |
|
Race |
White |
-54.8 (-59.0, -50.5) |
Black or African American |
-56.2 (-61.8, -50.7) |
|
Asian1 |
-55.6 (-61.5, -49.9) |
Source: Adapted from FDA Review
* Treatment differences and credible intervals include the relevance of outcomes from other subgroups
1 Includes: Asian and Native Hawaiian or other Pacific Islander
Abbreviations: CI, credible interval; LDL-C, low-density lipoprotein cholesterol; LS mean, least-squares
Table 6. Percent Change in LDL-C From Baseline at Week 52 by Subgroup, Trial 2, Efficacy Population
Group |
Subgroup |
LS Mean (95% CI)* |
|---|---|---|
Sex |
Female |
-48.3 (-53.5, -42.9) |
Male |
-51.1 (-56.1, -46.0) |
|
Age, years |
<65 |
-49.4 (-54.3, -44.5) |
≥65 |
-49.8 (-54.7, -45.1) |
|
Race |
White |
-49.5 (-54.0, -44.8) |
Black or African American |
-51.0 (-57.0, -45.3) |
|
Asian1 |
-50.2 (-56.4, -44.3) |
Source: Adapted from FDA Review
* Treatment differences and credible intervals include the relevance of outcomes from other subgroups
1 Includes: Asian, Native Hawaiian or other Pacific Islander, and American Indian or Alaska Native
Abbreviations: CI, credible interval; LDL-C, low-density lipoprotein cholesterol; LS mean, least-squares mean
Table 7. Percent Change in LDL-C From Baseline at Week 24 by Subgroup, Trial 3, Efficacy Population
Group |
Subgroup |
LS Mean (95% CI)* |
|---|---|---|
Sex |
Female |
-58.8 (-66.1, -51.7) |
Male |
-58.4 (-65.7, -51.2) |
|
Age, years |
<65 |
-58.6 (-65.9, -52.0) |
≥65 |
-58.3 (-66.2, -50.8) |
|
Race |
White |
-58.1 (-65.2, -51.1) |
Black or African American |
-58.1 (-66.3, -50.2) |
|
Asian |
-58.4 (-66.4, -50.2) |
Source: Adapted from FDA Review
* Treatment differences and credible intervals include the relevance of outcomes from other subgroups
Abbreviations: CI, credible interval; LDL-C, low-density lipoprotein cholesterol; LS mean, least-squares mean
What are the possible side effects?
Most common side effects include injection site reactions, nasopharyngitis, diarrhea, nausea, and peripheral edema.
What are the possible side effects (results of trials used to assess safety)?
Common sides effects were nasopharyngitis and injection site reactions. Serious adverse events were generally balanced between LEROCHOL-treated patients and placebo-treated patients in Trials 1 and 2.
Table 8. Adverse Reactions Occurring in ≥2% of LEROCHOL-Treated Patients With Hypercholesterolemia and >1% More Frequently Than Placebo-Treated Patients in Pooled Trials 1 and 2, Safety Population
Adverse Reactiona |
LEROCHOL |
Placebo |
|---|---|---|
Nasopharyngitis |
15 |
14 |
Injection site reactions |
12 |
5 |
Peripheral edema |
2 |
<1 |
Source: Adapted from LEROCHOL Prescribing Information
a Grouped terms composed of several similar terms
Were there any differences in side effects among sex, race, and age?
- Sex: The occurrence of side effects was similar in females and males.
- Race: The occurrence of side effects was similar by race.
- Age: The occurrence of side effects was similar in patients younger and older than 65 years of age.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Table 9. Overview of Adverse Events by Subgroup for Pooled Trials 1 and 2, Safety Population
Characteristic |
LEROCHOL |
Placebo |
Risk Difference |
|---|---|---|---|
Sex |
|
|
|
Female |
353/465 (75.9) |
165/224 (73.7) |
2.3 (‑4.5, 9.4) |
Male |
565/764 (74.0) |
296/388 (76.3) |
‑2.3 (‑7.5, 3.0) |
Age group, years |
|
|
|
≥18 to <65 |
444/608 (73.0) |
207/283 (73.1) |
‑0.1 (‑6.2, 6.3) |
≥65 |
474/621 (76.3) |
254/329 (77.2) |
‑0.9 (‑6.4, 4.9) |
Age group ≥75, years |
|
|
|
≥75 |
140/188 (74.5) |
78/103 (75.7) |
‑1.3 (‑11.2, 9.5) |
Race |
|
|
|
American Indian or Alaska Native |
1/1 (100) |
0/0 (NA) |
NA |
Asian |
22/41 (53.7) |
10/24 (41.7) |
12.0 (‑13.2, 35.4) |
Black or African American |
39/55 (70.9) |
15/22 (68.2) |
2.7 (‑18.1, 26.6) |
Native Hawaiian or other Pacific Islander |
1/1 (100) |
1/1 (100) |
0.0 (‑88.5, 88.5) |
Other |
81/156 (51.9) |
58/92 (63.0) |
-11.1 (‑23.3, 1.7) |
White |
774/975 (79.4) |
377/473 (79.7) |
‑0.3 (‑4.6, 4.2) |
Ethnicity |
|
|
|
Hispanic or Latino |
29/83 (34.9) |
16/49 (32.7) |
2.3 (‑14.8, 18.3) |
Not Hispanic or Latino |
883/1139 (77.5) |
441/558 (79.0) |
‑1.5 (‑5.6, 2.8) |
Not reported |
5/6 (83.3) |
1/1 (100) |
-16.7 (‑59.2, 71.0) |
Unknown |
1/1 (100) |
3/4 (75.0) |
25.0 (‑68.7, 73.4) |
Is in United States |
|
|
|
United States |
232/331 (70.1) |
125/174 (71.8) |
‑1.7 (‑9.8, 6.8) |
Non-United States |
686/898 (76.4) |
336/438 (76.7) |
‑0.3 (‑5.0, 4.6) |
Source: Adapted from FDA Review
Risk difference (with 95% confidence interval) is shown between total treatment and comparator.
Abbreviations: CI, confidence interval; N, number of patients in treatment arm; n, number of patients with adverse event; NA, not applicable; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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