Hypogonadism, Male
Conditions
Brief summary
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.
Detailed description
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects. The study is comprised of six scheduled visits: Visit 1 and 2 are for screening, Visit 3 is to assess subject's baseline BP and pulse rate (PR) via ABPM. Visit 4 is to enroll subjects, and to provide subjects with study medication for the start of dosing. Visit 5 is to assess subject's post-treatment BP and PR via ABPM. Visit 6 is to perform exit visit procedures.
Interventions
DRUGLPCN 1021
LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
Sponsors
Lipocine Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures. 2. Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65. 3. Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired). 4. Serum total T below lab normal range (300 ng/dL) based on two consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy, if required. 5. Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility. 6. Judged to be in good general health as determined by the investigator at screening.
Exclusion criteria
1. History of significant sensitivity or allergy to androgens, or product excipients. 2. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to: 1. Hemoglobin \< 11.5 g/dL or \> 16.5 g/dL 2. Hematocrit \< 35% or \> 54% 3. Serum transaminases \> 2.5 times upper limit of normal 4. Serum bilirubin \> 2.0 mg/dL 5. Creatinine \> 2.0 mg/dL 6. PSA \> 4 ng/mL 7. Prolactin \> 17.7 ng/mL. 3. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up. 4. Subjects with screening systolic BP or diastolic BP above 160 mmHg or 100 mmHg, respectively. 5. Subjects with symptoms of moderate to severe benign prostatic hyperplasia. 6. History of seizures or convulsions occurring after age 5, including alcohol or drug withdrawal seizures. 7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption. 8. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration. 9. Known tolerability issues with ABPM devices. 10. History of stroke, myocardial infarction, transient ischemic attack, or acute coronary syndrome within the past 5 years. 11. History of long QT syndrome (or QTcB \> 450) or unexplained sudden death (including cardiac death) or history of long QT syndrome in a first degree relative (parent, sibling, or child). 12. Subjects who are not on stable dose of current medication (no changes in medication in the last 3 months). 13. History of current or suspected prostate or breast cancer. 14. History of untreated obstructive sleep apnea or not compliant with sleep apnea treatment. 15. Active alcohol or any drug substance abuse, or history of abuse that will interfere with the subject's ability to participate in the study in the judgement of the investigator. 16. Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study. A list of prohibited medications is provided in Appendix C. 17. Use of any investigational drug within 5 half-lives of the last dose in the past 6 months prior to Study Day -2 without principal investigator and/or sponsor approval. 18. Receipt of any investigational drug by injection within 30 days or 10 half-lives (whichever is longer) prior to study drug administration without principal investigator and/or sponsor approval. 19. Subject who is not willing to use adequate contraception for the duration of the study. 20. Any contraindications to a MRI scan (i.e. subjects with non-removable ferromagnetic implants, pacemakers, aneurysm clips or other foreign bodies), and/or subjects with claustrophobic symptoms and/or inability to fit into an MRI scanner. 21. Inability to understand and provide written informed consent for the study. 22. Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive LPCN 1021 (exact reason should be specified by the investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP) | Baseline to end of study (approximately 4 months). | Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ABPM-measured Average 24-hour Pulse Rate (PR) | Baseline to End of Study (approximately 4 months) | Change in average 24-hour pulse rate as measured by ABPM from Visit 3 to Visit 5 |
| Change in Morning DBP Measured in Triplicate at the Clinic | Baseline to End of Study (approximately 4 months) | Change in morning diastolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5 |
| Change in Morning PR Measured in Triplicate at the Clinic | Baseline to End of Study (approximately 4 months) | Change in morning pulse rate measured in triplicate at the clinic from Visit 3 to Visit 5 |
| Change in Patient Reported Sexual Distress | Baseline to End of Study (approximately 4 months) | Change in patient reported sexual distress from visit 3 to Visit 5 Female Sexual Distress Scale - Revised, Item 13 Possible scores range from 0 (better) to 4 (worse) |
| Change in Patient Reported Sexual Desire | Baseline to End of Study (approximately 4 months) | Change in patient reported sexual desire from visit 3 to Visit 5 Psychosexual Daily Questionnaire Possible scores range from 0 (worse) to 5 (better) |
| Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5% | Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks) | Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥5% |
| Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5% | Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks) | Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥5% |
| Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10% | Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks) | Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥10% |
| Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10% | Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks) | Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥10% |
| Change in ABPM-measured Average Daytime SBP | Baseline to End of Study (approximately 4 months) | Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5 |
| Change in ABPM-measured Average Nighttime SBP | Baseline to End of Study (approximately 4 months) | Change in average nighttime SBP as measured by ABPM from Visit 3 to Visit 5 |
| Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP) | Baseline to End of Study (approximately 4 months) | Change in average 24-hour DBP as measured by ABPM from Visit 3 to Visit 5 |
| Change in ABPM-measured Average Daytime DBP | Baseline to End of Study (approximately 4 months) | Change in average daytime DBP as measured by ABPM from Visit 3 to Visit 5 |
| Change in ABPM-measured Average Nighttime DBP | Baseline to End of Study (approximately 4 months) | Change in average nighttime DBP as measured by ABPM from Visit 3 to Visit 5 |
| Change in ABPM-measured Average Daytime PR | Baseline to End of Study (approximately 4 months) | Change in average daytime pulse rate as measured by ABPM from Visit 3 to Visit 5 |
| Change in ABPM-measured Average Nighttime PR | Baseline to End of Study (approximately 4 months) | Change in average nighttime pulse rate as measured by ABPM from Visit 3 to Visit 5 |
| Change in Morning SBP Measured in Triplicate at the Clinic | Baseline to End of Study (approximately 4 months) | Change in morning systolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS) | Baseline to End of Study (approximately 4 months) | Change in average 24-hour SBP in subjects with a moderate cardiovascular risk based on their Framingham Risk Score (11≤FRS\<24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24. |
| Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS) | Baseline to End of Study (approximately 4 months) | Change in average 24-hour SBP in subjects with a high cardiovascular risk based on their Framingham Risk Score (FRS≥24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24. |
| Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg | Baseline to End of Study (approximately 4 months) | Change in average 24-hour SBP as measured by ABPM in subjects with a baseline SBP \>140mmHg from Visit 3 to Visit 5 |
| Change in Hematocrit From Baseline | Baseline to end of Study (approximately 4 months) | Change in Hematocrit (%) from Visit 3 to Visit 5 |
| Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose | Baseline to End of Study (approximately 4 months) | Number of participants who had to start a new hypertensive medication or increase their hypertensive medication dose from Visit 3 to Visit 5 |
| Change in Hemoglobin From Baseline | Baseline to End of Study (approximately 4 months) | Change in Hemoglobin from Visit 3 to Visit 5 |
| Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS) | Baseline to End of Study (approximately 4 months) | Change in average 24-hour SBP in subjects with a low cardiovascular risk based on their Framingham Risk Score (0\<FRS\<11) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24. |
| Change is SBP Dip | Baseline to End of Study (approximately 4 months) | Change in systolic blood pressure dip, as defined as the difference between daytime mean systolic blood pressure and nighttime mean systolic blood pressure, from Visit 3 to Visit 5 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LPCN 1021 LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule. | 138 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | LPCN 1021 |
|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 10.18 |
| Body Mass Index | 33.12 kg/m^2 STANDARD_DEVIATION 5.75 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 109 Participants |
| Region of Enrollment United States | 138 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 138 |
| other Total, other adverse events | 22 / 138 |
| serious Total, serious adverse events | 2 / 138 |
Outcome results
Primary
Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)
Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)
Time frame: Baseline to end of study (approximately 4 months).
Population: Subjects who had evaluable average 24-hour SBP measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP) | 3.8 mmHg | Standard Deviation 11.8 |
Secondary
Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)
Change in average 24-hour DBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects with evaluable average 24-hour DBP measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP) | 1.2 mmHg | Standard Deviation 4.9 |
Secondary
Change in ABPM-measured Average 24-hour Pulse Rate (PR)
Change in average 24-hour pulse rate as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable average 24-hour PR measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average 24-hour Pulse Rate (PR) | 2.0 bpm | Standard Deviation 5.9 |
Secondary
Change in ABPM-measured Average Daytime DBP
Change in average daytime DBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable average daytime DBP measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average Daytime DBP | 1.7 mmHg | Standard Deviation 6.5 |
Secondary
Change in ABPM-measured Average Daytime PR
Change in average daytime pulse rate as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable average daytime PR measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average Daytime PR | 2.6 bpm | Standard Deviation 6.9 |
Secondary
Change in ABPM-measured Average Daytime SBP
Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable average daytime SBP measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average Daytime SBP | 5.2 mmHg | Standard Deviation 14.9 |
Secondary
Change in ABPM-measured Average Nighttime DBP
Change in average nighttime DBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable average nighttime DBP measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average Nighttime DBP | 1.7 mmHg | Standard Deviation 7.2 |
Secondary
Change in ABPM-measured Average Nighttime PR
Change in average nighttime pulse rate as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable average nighttime PR measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average Nighttime PR | 0.44 bpm | Standard Deviation 7.2 |
Secondary
Change in ABPM-measured Average Nighttime SBP
Change in average nighttime SBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects with evaluable average nighttime SBP measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average Nighttime SBP | 4.3 mmHg | Standard Deviation 16.7 |
Secondary
Change in Morning DBP Measured in Triplicate at the Clinic
Change in morning diastolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable morning DBP measurements in triplicate at the clinic at Baseline and end of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in Morning DBP Measured in Triplicate at the Clinic | 1.6 mmHg | Standard Deviation 7.9 |
Secondary
Change in Morning PR Measured in Triplicate at the Clinic
Change in morning pulse rate measured in triplicate at the clinic from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable morning PR measurements in triplicate at the clinic at Baseline and End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in Morning PR Measured in Triplicate at the Clinic | 2.0 bpm | Standard Deviation 9.8 |
Secondary
Change in Morning SBP Measured in Triplicate at the Clinic
Change in morning systolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable morning SBP measurements in triplicate at the clinic at Baseline and end of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in Morning SBP Measured in Triplicate at the Clinic | 4.8 mmHg | Standard Deviation 12.4 |
Secondary
Change in Patient Reported Sexual Desire
Change in patient reported sexual desire from visit 3 to Visit 5 Psychosexual Daily Questionnaire Possible scores range from 0 (worse) to 5 (better)
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects with evaluable patient reported sexual desire questionnaire responses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in Patient Reported Sexual Desire | 1.2 units on a scale | Standard Deviation 1.1 |
Secondary
Change in Patient Reported Sexual Distress
Change in patient reported sexual distress from visit 3 to Visit 5 Female Sexual Distress Scale - Revised, Item 13 Possible scores range from 0 (better) to 4 (worse)
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects with evaluable patient reported sexual distress questionnaire responses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in Patient Reported Sexual Distress | -0.3 units on a scale | Standard Deviation 1.32 |
Secondary
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥10%
Time frame: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Population: Subjects with evaluable baseline and interim MRI-PDFF data, with MRI-PDFF measurement of ≥10% at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10% | -38.5 % Relative Change | Standard Deviation 27.5 |
Secondary
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥5%
Time frame: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Population: Subjects with evaluable baseline and interim MRI-PDFF data, with MRI-PDFF measurement of ≥5% at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5% | -13.5 % Relative Change | Standard Deviation 49 |
Secondary
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥10%
Time frame: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)
Population: Subjects with evaluable baseline and post-treatment MRI-PDFF data, with MRI-PDFF measurement of ≥10% at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10% | -39.7 % Relative Change | Standard Deviation 32.6 |
Secondary
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥5%
Time frame: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)
Population: Subjects with evaluable baseline and post-treatment MRI-PDFF data, with MRI-PDFF measurement of ≥5% at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5% | -33.4 % Relative Change | Standard Deviation 31.5 |
Other Pre-specified
Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg
Change in average 24-hour SBP as measured by ABPM in subjects with a baseline SBP \>140mmHg from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects with a baseline SBP \>140mmHg who had evaluable average 24-hour SBP measurements from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg | -3.0 mmHg | Standard Deviation 13.7 |
Other Pre-specified
Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS)
Change in average 24-hour SBP in subjects with a high cardiovascular risk based on their Framingham Risk Score (FRS≥24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects with a high FRS (FRS≥24) who had evaluable 24-hour SBP measurements from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS) | -1.8 mmHg | Standard Deviation 14.9 |
Other Pre-specified
Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)
Change in average 24-hour SBP in subjects with a low cardiovascular risk based on their Framingham Risk Score (0\<FRS\<11) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects with a low FRS (0\<FRS\<11) who had evaluable 24-hour SBP measurements from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS) | 2.6 mmHg | Standard Deviation 2.7 |
Other Pre-specified
Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)
Change in average 24-hour SBP in subjects with a moderate cardiovascular risk based on their Framingham Risk Score (11≤FRS\<24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects with a medium FRS (11≤FRS\<24) who had evaluable 24-hour SBP measurements from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS) | 4.8 mmHg | Standard Deviation 13.1 |
Other Pre-specified
Change in Hematocrit From Baseline
Change in Hematocrit (%) from Visit 3 to Visit 5
Time frame: Baseline to end of Study (approximately 4 months)
Population: Subjects with evaluable Hematocrit values from baseline and end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in Hematocrit From Baseline | 3.2 percentage of hematocrit | Standard Deviation 3.6 |
Other Pre-specified
Change in Hemoglobin From Baseline
Change in Hemoglobin from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects with evaluable Hemoglobin values from baseline and end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change in Hemoglobin From Baseline | 0.87 g/dL | Standard Deviation 1.05 |
Other Pre-specified
Change is SBP Dip
Change in systolic blood pressure dip, as defined as the difference between daytime mean systolic blood pressure and nighttime mean systolic blood pressure, from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Population: Subjects who had evaluable SBP dip measurements from Baseline to End of Study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LPCN 1021 | Change is SBP Dip | 0.5 mmHg | Standard Deviation 9.4 |
Other Pre-specified
Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose
Number of participants who had to start a new hypertensive medication or increase their hypertensive medication dose from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LPCN 1021 | Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose | 2 Participants |