Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC24h) for VupanorsenPrimary· 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on day 1
AUC24h is the area under the concentration-time profile from time 0 to 24 hour post-dose
Group
Value
95% CI
Vupanorsen 80 mg
3.649
± 35
Vupanorsen 160 mg
10.82
± 42
AUC From Time 0 to 48 Hours Post-dose (AUC48h) for VupanorsenPrimary· 0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose
AUC48h is the area under the plasma concentration-time profile from time zero to the quantifiable concentration 48 hours post-dose
Group
Value
95% CI
Vupanorsen 80 mg
3.699
± 34
Vupanorsen 160 mg
10.91
± 42
AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for VupanorsenPrimary· 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)
Group
Value
95% CI
Vupanorsen 80 mg
3.950
± 34
Vupanorsen 160 mg
11.76
± 39
Maximum Observed Concentration (Cmax)Primary· 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Maximum plasma concentration observed from data
Group
Value
95% CI
Vupanorsen 80 mg
0.5879
± 62
Vupanorsen 160 mg
1.810
± 63
AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for VupanorsenPrimary· 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time
Group
Value
95% CI
Vupanorsen 80 mg
4.081
± 36
Vupanorsen 160 mg
11.91
± 39
Time for Cmax (Tmax) for VupanorsenPrimary· 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Time for Cmax (Tmax) for vupanorsen
Group
Value
95% CI
Vupanorsen 80 mg
2.00
1.50 – 3.00
Vupanorsen 160 mg
2.00
1.50 – 3.00
Terminal Elimination Half Life (t½) for VupanorsenPrimary· 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
terminal elimination half life (t½) for vupanorsen
Group
Value
95% CI
Vupanorsen 80 mg
475.9
± 205.50
Vupanorsen 160 mg
465.2
± 131.50
Apparent Clearance (CL/F) for VupanorsenPrimary· 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Apparent clearance for vupanorsen
Group
Value
95% CI
Vupanorsen 80 mg
19.60
± 36
Vupanorsen 160 mg
13.43
± 39
Apparent Volume of Distribution (Vz/F) for VupanorsenPrimary· 0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90
Apparent volume of distribution for vupanorsen
Group
Value
95% CI
Vupanorsen 80 mg
12500
± 37
Vupanorsen 160 mg
8681
± 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Secondary· Baseline through day 90
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Causality to study treatment was determined by the investigator.
All-causality
Group
Value
95% CI
Vupanorsen 80 mg
3
Vupanorsen 160 mg
5
Treatment-related
Group
Value
95% CI
Vupanorsen 80 mg
2
Vupanorsen 160 mg
1
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)Secondary· Baseline through day 90
Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria.
Group
Value
95% CI
Vupanorsen 80 mg
5
Vupanorsen 160 mg
5
Number of Participants With Clinically Significant Vital Sign ValuesSecondary· Baseline through day 90
Vital sign data included blood pressure and pulse rate. Clinical significance was assessed by the investigator.
Group
Value
95% CI
Vupanorsen 80 mg
1
Vupanorsen 160 mg
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline through day 90.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 1, randomized, parallel-cohort, open-label study to characterize the pharmacokinetics, pharmacodynamics, safety and tolerability of vupanorsen following 80 mg and 160 mg single subcutaneous dose in healthy Chinese adults with elevated fasting triglyceride.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04516291 — A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
· Phase 2
· completed
NCT04459767 — Investigation Of Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Doses Of Vupanorsen In Japanese H
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 12 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04916795.