Trial · NCT04516291
A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
NCT04516291, Phase 2, Completed, Pfizer; results first posted 2022-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70). Trials, record NCT04516291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04516291
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
- NCT number
- NCT04516291
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 286 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Dyslipidemias, Hyperlipidemias, Hyperlipoproteinemias
- Interventions
- Vupanorsen, Placebo
- First posted
- 2020-08-18
- Last updated
- 2022-10-04
- Other registries' IDs
- eudract:2020-002796-35
- Results first posted
- 2022-10-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Baseline, Week 24 | Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing. |
| Secondary | Percent Change From Baseline in Triglyceride (TG), Apolipoprotein B (ApoB), Low-Density Lipoprotein-Cholesterol (LDL-C), and Non-HDL-C at Week 16 | Baseline, Week 16 | Blood samples were collected from participants in a fasted state for the measurement of TG, ApoB, HDL-C and LDL-C. Fasting was required at least 10 hours before blood sample collection. Non-HDL-C was calculated as total cholesterol minus HDL cholesterol. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing. |
| Secondary | Percent Change From Baseline in TG, ApoB, and LDL-C at Week 24 | Baseline, Week 24 | Fasting was required for all lipid measures at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing. |
| Secondary | Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 16 | Baseline, Week 16 | ANGPTL3 is a protein primarily synthesized and secreted by the liver and is a member of the angiopoietin-like family of proteins. Blood samples were collected from participants in a fasted state for the measurement of ANGPTL3. Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing. |
| Secondary | Percent Change From Baseline in ANGPTL3 at Week 24 | Baseline, Week 24 | ANGPTL3 is a protein primarily synthesized and secreted by the liver and is a member of the angiopoietin-like family of proteins. Blood samples were collected from participants in a fasted state for the measurement of ANGPTL3. Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Baseline, Week 24 | Full analysis set primary (FAS\_primary) included all participants randomized to study intervention and who took at least 1 dose of study intervention, had a baseline measurement and at least one post-baseline measurement with all observations that occurred after discontinuation of treatment or after initiation of severe hypertriglyceridemia excluded. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Triglyceride (TG), Apolipoprotein B (ApoB), Low-Density Lipoprotein-Cholesterol (LDL-C), and Non-HDL-C at Week 16 | Baseline, Week 16 | FAS included all participants randomized to study intervention and who took at least 1 dose of study intervention and had a baseline measurement and at least one post-baseline measurement. Here, Number Analyzed signifies participants evaluable for specific rows. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in TG, ApoB, and LDL-C at Week 24 | Baseline, Week 24 | FAS\_primary included all participants randomized to study intervention and who took at least 1 dose of study intervention, had a baseline measurement and at least one post-baseline measurement with all observations that occurred after discontinuation of treatment or after initiation of severe hypertriglyceridemia excluded. Here, Number Analyzed signifies participants evaluable for specific rows. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 16 | Baseline, Week 16 | FAS included all participants randomized to study intervention and who took at least 1 dose of study intervention and had a baseline measurement and at least one post-baseline measurement. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in ANGPTL3 at Week 24 | Baseline, Week 24 | FAS\_primary included all participants randomized to study intervention and who took at least 1 dose of study intervention, had a baseline measurement and at least one post-baseline measurement with all observations that occurred after discontinuation of treatment or after initiation of severe hypertriglyceridemia excluded. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Placebo | -1.1 | Standard Error 2.76 | Percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Vupanorsen: 80 mg Q4W | -23.5 | Standard Error 4.08 | Percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Vupanorsen: 60 mg Q2W | -23.2 | Standard Error 4.02 | Percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Vupanorsen: 120 mg Q4W | -25.3 | Standard Error 4.23 | Percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Vupanorsen: 80 mg Q2W | -28.8 | Standard Error 3.02 | Percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Vupanorsen: 160 mg Q4W | -27.8 | Standard Error 2.88 | Percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Vupanorsen: 120 mg Q2W | -25.8 | Standard Error 2.84 | Percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 | Vupanorsen: 160 mg Q2W | -27.6 | Standard Error 3.57 | Percent change | |
| Percent Change From Baseline in Triglyceride (TG), Apolipoprotein B (ApoB), Low-Density Lipoprotein-Cholesterol (LDL-C), and Non-HDL-C at Week 16 | Placebo | TG | -2.53 | Standard Deviation 31.247 | Percent change |
| Percent Change From Baseline in Triglyceride (TG), Apolipoprotein B (ApoB), Low-Density Lipoprotein-Cholesterol (LDL-C), and Non-HDL-C at Week 16 | Vupanorsen: 80 mg Q4W | TG | -42.17 | Standard Deviation 28.081 | Percent change |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (24 Weeks) | STARTED | Placebo | 44 | |
| Treatment Period (24 Weeks) | STARTED | Vupanorsen: 80 mg Q4W | 23 | |
| Treatment Period (24 Weeks) | STARTED | Vupanorsen: 60 mg Q2W | 24 | |
| Treatment Period (24 Weeks) | STARTED | Vupanorsen: 120 mg Q4W | 23 | |
| Treatment Period (24 Weeks) | STARTED | Vupanorsen: 80 mg Q2W | 45 | |
| Treatment Period (24 Weeks) | STARTED | Vupanorsen: 160 mg Q4W | 45 | |
| Treatment Period (24 Weeks) | STARTED | Vupanorsen: 120 mg Q2W | 46 | |
| Treatment Period (24 Weeks) | STARTED | Vupanorsen: 160 mg Q2W | 36 | |
| Treatment Period (24 Weeks) | COMPLETED | Placebo | 42 | |
| Treatment Period (24 Weeks) | COMPLETED | Vupanorsen: 80 mg Q4W | 18 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events2,040
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 44 | |
| other | Anaemia | Blood and lymphatic system disorders | Vupanorsen: 80 mg Q4W | 0 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | Vupanorsen: 60 mg Q2W | 0 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Vupanorsen: 120 mg Q4W | 0 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | Vupanorsen: 80 mg Q2W | 0 | 45 | |
| other | Anaemia | Blood and lymphatic system disorders | Vupanorsen: 160 mg Q4W | 0 | 45 | |
| other | Anaemia | Blood and lymphatic system disorders | Vupanorsen: 120 mg Q2W | 0 | 46 | |
| other | Anaemia | Blood and lymphatic system disorders | Vupanorsen: 160 mg Q2W | 0 | 36 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Placebo | 0 | 44 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Vupanorsen: 80 mg Q4W | 0 | 23 |
1 to 10 of 2,040Source ClinicalTrials.gov
See all 2,040 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 44 |
| Total, all-cause mortality | Vupanorsen: 80 mg Q4W | 0 | 23 |
| Total, all-cause mortality | Vupanorsen: 60 mg Q2W | 0 | 24 |
| Total, all-cause mortality | Vupanorsen: 120 mg Q4W | 0 | 23 |
| Total, all-cause mortality | Vupanorsen: 80 mg Q2W | 0 | 45 |
| Total, all-cause mortality | Vupanorsen: 160 mg Q4W | 0 | 45 |
| Total, all-cause mortality | Vupanorsen: 120 mg Q2W | 0 | 46 |
| Total, all-cause mortality | Vupanorsen: 160 mg Q2W | 0 | 36 |
| Total, other adverse events | Placebo | 31 | 44 |
| Total, other adverse events | Vupanorsen: 80 mg Q4W | 15 | 23 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35369705 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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