Mixed Dyslipidemia
Conditions
Brief summary
Percent change from baseline in TG levels at week 16.
Detailed description
Frequency, intensity and seriousness of the AEs during the trial. Clinically significant changes in laboratory parameters, vital signs, physical examinations and 12-lead ECG at each visit from baseline to week 48 (end of trial)., Percent change from baseline in TG levels at week 4, 8, 12, 20, 24, 32, 40 and 48., Percent change from baseline in apoC-III levels at week 4, 8, 12, 16, 20, 24, 32, 40 and 48., Plasma concentrations of RBD5044 will be summarized with descriptive statistics by sampling collection time point., Percent change from baseline in lipid parameters TC, LDL-C, HDL-C, non-HDL-C, TRL-C, ApoB, ApoA1, Lp (a) at week 4, 8, 12, 16, 20, 24, 32, 40 and 48.
Interventions
DRUGRBD3000 Placebo Injection is a clear
DRUGcolorless sterile solution for subcutaneous injection
DRUGwhich is formulated by 25 mM phosphate buffer
Sponsors
Ribocure Pharmaceuticals AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in TG levels at week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency, intensity and seriousness of the AEs during the trial. Clinically significant changes in laboratory parameters, vital signs, physical examinations and 12-lead ECG at each visit from baseline to week 48 (end of trial)., Percent change from baseline in TG levels at week 4, 8, 12, 20, 24, 32, 40 and 48., Percent change from baseline in apoC-III levels at week 4, 8, 12, 16, 20, 24, 32, 40 and 48., Plasma concentrations of RBD5044 will be summarized with descriptive statistics by sampling collection time point., Percent change from baseline in lipid parameters TC, LDL-C, HDL-C, non-HDL-C, TRL-C, ApoB, ApoA1, Lp (a) at week 4, 8, 12, 16, 20, 24, 32, 40 and 48. | — |
Countries
Sweden
Outcome results
None listed