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This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up and a 15-week PK follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | once-daily placebo |
|
| obicetrapib 5 mg | Experimental | once-daily obicetrapib |
|
| obicetrapib 10 mg | Experimental | once-daily obicetrapib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obicetrapib | Drug | tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC), | 8-weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. [Friedewald] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC), | 8-Weeks |
| LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | LS mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. [Friedewald] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC), | 8-Weeks |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC). | 8-Weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Apolipoprotein B (ApoB) | Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. | 8-Weeks |
| Median Percent Change in Apolipoprotein B (ApoB) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| National Research Institute - Huntington Park |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35953719 | Result | Nicholls SJ, Ditmarsch M, Kastelein JJ, Rigby SP, Kling D, Curcio DL, Alp NJ, Davidson MH. Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial. Nat Med. 2022 Aug;28(8):1672-1678. doi: 10.1038/s41591-022-01936-7. Epub 2022 Aug 11. |
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195 participants were screened; out of 195, 120 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | once-daily placebo Obicetrapib: tablets |
| FG001 | Obicetrapib 5 mg | once-daily obicetrapib Obicetrapib: tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2021 | May 13, 2024 |
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Placebo-controlled, double-blind, randomized
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placebo tablet made to resemble active
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
| 8-Weeks |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | LS Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured directly by preparative ultracentrifugation (PUC). | 8-Weeks |
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
| 8-Week |
| LS Mean Percent Change in Apolipoprotein B (ApoB) | Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. | 8-Weeks |
| Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group | 8-weeks |
| Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group | 8-Weeks |
| LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group | 8-Weeks |
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. | 8-weeks |
| Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. | 8-Weeks |
| LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | LS mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. | 8-Weeks |
| Huntington Park |
| California |
| 90255 |
| United States |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | United States |
| Clinical Trials Research | Sacramento | California | 95821 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Ocala Cardiovascular Research | Ocala | Florida | 34474 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| IACT Health | Columbus | Georgia | 31904 | United States |
| Evanston Premier Healthcare Research LLC | Evanston | Illinois | 60201 | United States |
| Midwest Institute for Clinical Research | Indianapolis | Indiana | 46260 | United States |
| Oakland Medical Research Center | Troy | Michigan | 48085 | United States |
| Diabetes and Endocrinology Consultants, P.C. | Morehead City | North Carolina | 28557 | United States |
| Lillestol Research, LLC | Fargo | North Dakota | 58104 | United States |
| Metabolic and Atherosclerosis Research Center | Cincinnati | Ohio | 45227 | United States |
| Summit Research Group, LLC | Munroe Falls | Ohio | 44262 | United States |
| Monument Health Clinical Research | Rapid City | South Dakota | 57701 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Juno Research, LL | Houston | Texas | 77040 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| FG002 | Obicetrapib 10 mg | once-daily obicetrapib Obicetrapib: tablets |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | once-daily placebo Obicetrapib: tablets |
| BG001 | Obicetrapib 5 mg | once-daily obicetrapib Obicetrapib: tablets |
| BG002 | Obicetrapib 10 mg | once-daily obicetrapib Obicetrapib: tablets |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values | Baseline LDL-C is defined as the last measurement prior to the first dose of study drug. LDL-C was calculated using the Friedewald Formula. | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC), | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8-weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. [Friedewald] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC), | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | LS mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. [Friedewald] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC), | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC). | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC). | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | LS Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured directly by preparative ultracentrifugation (PUC). | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in Apolipoprotein B (ApoB) | Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change in Apolipoprotein B (ApoB) | Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8-Week |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | LS Mean Percent Change in Apolipoprotein B (ApoB) | Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8-weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8-weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8-Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | LS mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. | Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8-Weeks |
|
|
From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | once-daily placebo Obicetrapib: tablets | 0 | 40 | 2 | 40 | 17 | 40 |
| EG001 | Obicetrapib 5 mg | once-daily obicetrapib Obicetrapib: tablets | 0 | 40 | 0 | 40 | 15 | 40 |
| EG002 | Obicetrapib 10 mg | once-daily obicetrapib Obicetrapib: tablets | 0 | 40 | 0 | 40 | 8 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischemic attack | Nervous system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA v23.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v23.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA v23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23.1 | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA v23.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA v23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA v23.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v23.1 | Systematic Assessment |
|
After the multicenter publication or 12 months after completion of the study, whichever occurs first, Institution may publish the results of its study data. Institution and PI shall provide sponsor with an advance copy of any proposed communications at least 60 days prior and Sponsor shall have 60 days to review. Sponsor may request (a) the deletion of any Confidential Information, (b) reasonable changes, or (c) a delay for an additional period, not to exceed 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | NewAmsterdam Pharma | +1(305) 627-3081 | study.director@newamsterdampharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 7, 2021 | May 13, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
mixed model for repeated measures (MMRM) with missing at random assumption |
| <.0001 |
| Least Squares (LS) Means |
| -39.18 |
| Standard Error of the Mean |
| 4.927 |
| 2-Sided |
| 95 |
| -50.21 |
| -28.15 |
| Superiority |
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