Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RBD5044, Placebo.
- Who it may be relevant to
- Registry conditions: Dyslipidemias. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia
Overview
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.
Detailed description
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.
Interventions
- Drug RBD5044
RBD5044, active drug. - Drug Placebo
Placebo that is identical in appearance and volume to the doses of active IMP.
Primary outcome measures
- Change from baseline in triglyceride (TG) levels at week 16 [Time frame: From baseline until end week 16]
Secondary outcome measures (5)
- Frequency, intensity and seriousness of the AEs during the trial [Time frame: Each visit from baseline to week 48 (end of trial)]
- Change from baseline in triglyceride (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 [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 [Time frame: week 4, 8, 12, 16, 20, 24, 32, 40 and 48]
Eligibility criteria
Inclusion criteria
- Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
- Male or female participants, aged 18 to 80 years inclusive.
- Fasting TG level of ≥ 150 mg/dL (≥ 1.69 mmol/L) and <499 mg/dL (5.61 mmol/L).
- Fasting levels at screening of non-HDL-C ≥ 100 mg/dL (2.59 mmol/L), or low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL (1.8 mmol/L) after at least 4 weeks of stable diet and stable optimal statin therapy (+ or - ezetimibe) if indicated.
- Body mass index between 18 and 40 kg/m2.
Exclusion criteria
- Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical trial and/or put the participant at significant risk (according to the investigator's judgment) if he/she participates in the clinical trial.
- Uncontrolled hypertension (blood pressure >160/100 mmHg at screening). (If untreated, participant may be re-screened once hypertension is treated and controlled).
- Active or history of serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression, which require current pharmacological intervention. Participants with a history of severe depression who are no longer on medication.
- Any of the following laboratory values at screening:
Hepatic: ALT or AST >2× ULN at screening, eGFR <30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease \[MDRD\] equation) at Screening, HbA1c >9.0% (or >75 mmol/mol International Federation of Clinical Chemistry \[IFCC\] units) at screening.
- Patients with a diagnosis of HBV, HCV or HIV at screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Sweden · 4 centers
- Lunds Universitetssjukhus — Lund
- Ribocure Clinic/Ribocure Pharmaceuticals AB — Mölndal
- AkardoMedSite — Stockholm
- Akademiska Sjukhuset Uppsala — Uppsala
Identifiers
NCT: NCT06797401 · RC02T001 · 2023-510369-92