A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
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ClinicalTrials.gov Identifier: NCT04516291 |
Recruitment Status :
Completed
First Posted : August 18, 2020
Results First Posted : October 4, 2022
Last Update Posted : October 4, 2022
|
Sponsor:
Pfizer
Collaborator:
TIMI Study Group
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Conditions |
Dyslipidemias Hyperlipidemias Hyperlipoproteinemias |
Interventions |
Drug: Vupanorsen Drug: Placebo |
Enrollment | 286 |
Participant Flow
Recruitment Details | Adult participants aged greater than equal to (>=) 40 years with dyslipidemia on a stable dose of statin (with or without ezetimibe) were included in the study. The study was conducted across 3 countries. |
Pre-assignment Details | 727 participants signed the inform consent form (ICF). 391 participants were screen failures who did not meet criteria and were not enrolled. 336 participants were enrolled into the study of which 50 participants were not randomized and 286 participants were assigned to a study treatment. |
Arm/Group Title | Placebo | Vupanorsen: 80 mg Q4W | Vupanorsen: 60 mg Q2W | Vupanorsen: 120 mg Q4W | Vupanorsen: 80 mg Q2W | Vupanorsen: 160 mg Q4W | Vupanorsen: 120 mg Q2W | Vupanorsen: 160 mg Q2W |
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Arm/Group Description | Participants were randomized to receive vupanorsen (PF-07285557) matched placebo subcutaneous (SC) injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. |
Period Title: Treatment Period (24 Weeks) | ||||||||
Started | 44 | 23 | 24 | 23 | 45 | 45 | 46 | 36 |
Completed | 42 | 18 | 20 | 17 | 33 | 37 | 37 | 22 |
Not Completed | 2 | 5 | 4 | 6 | 12 | 8 | 9 | 14 |
Reason Not Completed | ||||||||
Other | 1 | 0 | 0 | 2 | 2 | 4 | 2 | 0 |
Withdrawal by Subject | 0 | 2 | 1 | 0 | 1 | 0 | 0 | 0 |
Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Adverse Event | 1 | 2 | 3 | 3 | 9 | 4 | 7 | 14 |
Period Title: Follow-up Period (12 Weeks) | ||||||||
Started | 44 [1] | 23 [1] | 24 [1] | 23 [1] | 45 [1] | 45 [1] | 46 [1] | 36 [1] |
Completed | 44 | 22 | 23 | 21 | 43 | 45 | 46 | 36 |
Not Completed | 0 | 1 | 1 | 2 | 2 | 0 | 0 | 0 |
Reason Not Completed | ||||||||
Other | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Adverse Event | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
[1]
Number of participants to start this period may include participants that did not complete treatment period.
|
Baseline Characteristics
Arm/Group Title | Placebo | Vupanorsen: 80 mg Q4W | Vupanorsen: 60 mg Q2W | Vupanorsen: 120 mg Q4W | Vupanorsen: 80 mg Q2W | Vupanorsen: 160 mg Q4W | Vupanorsen: 120 mg Q2W | Vupanorsen: 160 mg Q2W | Total | |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants were randomized to receive vupanorsen (PF-07285557) matched placebo SC injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention. | Total of all reporting groups | |
Overall Number of Baseline Participants | 44 | 23 | 24 | 23 | 45 | 45 | 46 | 36 | 286 | |
Baseline Analysis Population Description |
Baseline analysis population included all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||||||||
Number Analyzed | 44 participants | 23 participants | 24 participants | 23 participants | 45 participants | 45 participants | 46 participants | 36 participants | 286 participants | |
64.23 (8.09) | 65.78 (7.27) | 64.21 (9.92) | 61.04 (9.31) | 63.38 (8.41) | 63.09 (8.80) | 62.74 (8.64) | 64.47 (7.74) | 63.57 (8.48) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 44 participants | 23 participants | 24 participants | 23 participants | 45 participants | 45 participants | 46 participants | 36 participants | 286 participants | |
Female |
17 38.6%
|
13 56.5%
|
7 29.2%
|
9 39.1%
|
24 53.3%
|
17 37.8%
|
20 43.5%
|
19 52.8%
|
126 44.1%
|
|
Male |
27 61.4%
|
10 43.5%
|
17 70.8%
|
14 60.9%
|
21 46.7%
|
28 62.2%
|
26 56.5%
|
17 47.2%
|
160 55.9%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 44 participants | 23 participants | 24 participants | 23 participants | 45 participants | 45 participants | 46 participants | 36 participants | 286 participants | |
Hispanic or Latino |
5 11.4%
|
2 8.7%
|
1 4.2%
|
6 26.1%
|
4 8.9%
|
6 13.3%
|
2 4.3%
|
1 2.8%
|
27 9.4%
|
|
Not Hispanic or Latino |
39 88.6%
|
21 91.3%
|
23 95.8%
|
17 73.9%
|
41 91.1%
|
39 86.7%
|
44 95.7%
|
35 97.2%
|
259 90.6%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 44 participants | 23 participants | 24 participants | 23 participants | 45 participants | 45 participants | 46 participants | 36 participants | 286 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
4 9.1%
|
2 8.7%
|
2 8.3%
|
1 4.3%
|
3 6.7%
|
0 0.0%
|
4 8.7%
|
4 11.1%
|
20 7.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
1 4.3%
|
1 4.2%
|
0 0.0%
|
4 8.9%
|
1 2.2%
|
4 8.7%
|
1 2.8%
|
12 4.2%
|
|
White |
38 86.4%
|
20 87.0%
|
21 87.5%
|
21 91.3%
|
38 84.4%
|
44 97.8%
|
37 80.4%
|
31 86.1%
|
250 87.4%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
2 4.5%
|
0 0.0%
|
0 0.0%
|
1 4.3%
|
0 0.0%
|
0 0.0%
|
1 2.2%
|
0 0.0%
|
4 1.4%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT04516291 |
Other Study ID Numbers: |
C4491011 2020-002796-35 ( EudraCT Number ) |
First Submitted: | August 13, 2020 |
First Posted: | August 18, 2020 |
Results First Submitted: | September 6, 2022 |
Results First Posted: | October 4, 2022 |
Last Update Posted: | October 4, 2022 |