Trial · NCT05089084
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG) | Baseline, Month 10 | |
| Secondary | Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged) | Baseline, Month 10, Month 12 | |
| Secondary | Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10 | Baseline, Month 10 | |
| Secondary | Percent Change From Baseline in Fasting APOC3 at Month 12 | Baseline, Month 12 | |
| Secondary | Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Randomized Period) | From first dose of study drug through Month 12 (Randomized Period) | All adverse events (AEs) and serious adverse events (SAEs) reported by the Investigator during the study that are consistent with an event of acute pancreatitis will be adjudicated by a blinded, independent committee according to the 2013 Atlanta definition meeting 2 of the following 3 criteria: 1. Abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back) 2. Serum lipase activity (or amylase activity) ≥3 times the upper limit of normal (×ULN) 3. Characteristic findings of acute pancreatitis on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI), or transabdominal ultrasonography. |
| Secondary | Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Open-Label Period) | From first dose of study drug through Month 36 (Open-Label Period) | All adverse events (AEs) and serious adverse events (SAEs) reported by the Investigator during the study that are consistent with an event of acute pancreatitis will be adjudicated by a blinded, independent committee according to the 2013 Atlanta definition meeting 2 of the following 3 criteria: 1. Abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back) 2. Serum lipase activity (or amylase activity) ≥3 times the upper limit of normal (×ULN) 3. Characteristic findings of acute pancreatitis on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI), or transabdominal ultrasonography. |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Month 10 | Baseline, Month 10 | |
| Secondary | Percent Change From Baseline in Non-HDL-C at Month 12 | Baseline, Month 12 | |
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Month 10 | Baseline, Month 10 | |
| Secondary | Percent Change From Baseline in HDL-C at Month 12 | Baseline, Month 12 | |
| Secondary | Percent Change From Baseline in Fasting Triglycerides (TG) at Month 12 | Baseline, Month 12 | |
| Secondary | Percentage of Participants Achieving Fasting TG of <500, 880, and 1000 mg/dL at Month 10 | Month 10 | |
| Secondary | Percentage of Participants Achieving Fasting TG of <500, 880, and 1000 mg/dL at Month 12 | Month 12 | |
| Secondary | Percentage of Participants Achieving ≥40% and ≥70% Reduction From Baseline in Fasting TG at Month 10 | Baseline, Month 10 | |
| Secondary | Change From Baseline in Fasting TG Over Time | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | |
| Secondary | Percent Change From Baseline in Fasting TG Over Time | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs; Randomized Period) | From first dose of study drug through Month 12 (Randomized Period) | AE: any untoward medical occurrence which does not necessarily have to have a causal relationship with treatment. Treatment-emergent AEs (TEAEs): AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. SAE: AE that fulfills one or more of the following: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above. Severity was reported as: mild, moderate, severe, life threatening, death. |
| Secondary | Number of Participants With Treatment-Emergent AEs and/or SAEs (Open-Label Period) | From first dose of open-label study drug through Month 36 (Open-Label Period) | AE: any untoward medical occurrence which does not necessarily have to have a causal relationship with treatment. Treatment-emergent AEs (TEAEs): AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. SAE: AE that fulfills one or more of the following: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above. Severity was reported as: mild, moderate, severe, life threatening, death. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05089084/registered