The goal of this clinical trial is to learn if drug RBD5044 works to treat mixed dyslipidemia in adults. It will also learn about the safety of drug RBD5044. The main questions it aims to answer are: Does drug RBD5044 reduce the triglyceride levels? What medical problems may participants experience when taking drug RBD5044? Researchers will compare drug RBD5044 to a placebo to see if drug RBD5044 works to treat mixed dyslipidemia. Participants will: Receive RBD5044 or placebo twice during the trial (Day 1 and Day 84). Visit the clinic 11 times during 12 months (visit every 4-8 weeks) for checkups and tests.
This is a multicentre, randomised, double-blinded, placebo-controlled, parallel-group phase 2 clinical trial to evaluate the efficacy and safety of RBD5044 subcutaneous injections in participants with mixed dyslipidemia. There will be 3 different dose level groups of RBD5044 or placebo: low dose (n=40), medium dose (n=40) or high dose (n=40). Within each of the 3 dose cohorts, participants will be randomly assigned in a 3:1 ratio to either active (RBD5044) treatment or to placebo treatment. All trial groups will be dosed in parallel. All participants will be dosed at their trial site and undergo blood sampling and examinations at pre-defined timepoints. Participants will be followed-up for 48 weeks from the first day of IMP/placebo administration. Primary endpoint evaluation will take place in week 16. End of trial is in week 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Lunds Universitetssjukhus
Lund, Sweden
RECRUITINGRibocure Clinic/Ribocure Pharmaceuticals AB
Mölndal, Sweden
RECRUITINGAkardoMedSite
Stockholm, Sweden
RECRUITINGAkademiska Sjukhuset Uppsala
Uppsala, Sweden
RECRUITINGChange from baseline in triglyceride (TG) levels at week 16
Percent change from baseline in TG levels at week 16.
Time frame: From baseline until end week 16
Frequency, intensity and seriousness of the AEs during the trial
Number and percentage of participants with AEs. All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).
Time frame: Each visit from baseline to week 48 (end of trial)
Change from baseline in triglyceride (TG) levels at different time points
Percent change from baseline in TG levels at different time points
Time frame: week 4, 8, 12, 20, 24, 32, 40 and 48
Change from baseline in ApoC-III levels at different time points
Percent change from baseline in ApoC-III levels at different time points
Time frame: week 4, 8, 12, 20, 24, 32, 40 and 48
Plasma concentrations of RBD5044
Time frame: In conjunction of administration of the IMP
Change from baseline in lipid parameters levels at different time points
Percent change from baseline in TC, LDL-C, HDL-C, non-HDL-C, TRL-C, ApoB, ApoA1, Lp (a) levels at different time points
Time frame: week 4, 8, 12, 16, 20, 24, 32, 40 and 48
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