Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia

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.

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: Placebo; Drug: RBD5044

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rebeckha Magnusson; Phone Number: 0046317207800; Email: rebeckha.magnusson@ribocure.com

Study Locations

• Sweden
  • Lund, Sweden
    • Recruiting
    • Lunds Universitetssjukhus
    • Contact: David Erlinge, MD, PhD
  • Mölndal, Sweden
    • Recruiting
    • Ribocure Clinic/Ribocure Pharmaceuticals AB
    • Contact: Sara Svedlund, MD, PhD
  • Stockholm, Sweden
    • Recruiting
    • AkardoMedSite
    • Contact: Åke Olsson, MD, PhD
  • Uppsala, Sweden
    • Recruiting
    • Akademiska Sjukhuset Uppsala
    • Contact: Emil Hagström, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose group; Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84.	Drug: Placebo; Placebo that is identical in appearance and volume to the doses of active IMP.; Drug: RBD5044; RBD5044, active drug.
Experimental: Medium dose group; Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84.	Drug: Placebo; Placebo that is identical in appearance and volume to the doses of active IMP.; Drug: RBD5044; RBD5044, active drug.
Experimental: High dose group; Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84.	Drug: Placebo; Placebo that is identical in appearance and volume to the doses of active IMP.; Drug: RBD5044; RBD5044, active drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in triglyceride (TG) levels at week 16	Percent change from baseline in TG levels at week 16.	From baseline until end week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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	week 4, 8, 12, 20, 24, 32, 40 and 48
Plasma concentrations of RBD5044		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	week 4, 8, 12, 16, 20, 24, 32, 40 and 48

Collaborators and Investigators

• Sponsor: Ribocure Pharmaceuticals AB
• Investigators: Principal Investigator: Sara Svedlund, MD, PhD, Ribocure Clinic/Ribocure Pharmaceuticals AB; Principal Investigator: David Erlinge, MD, PhD, Lunds Universitetssjukhus; Principal Investigator: Emil Hagström, MD, PhD, Akademiska Sjukhuset Uppsala; Principal Investigator: Åke Olsson, MD, PhD, AkardoMedSite

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Mixed dyslipidemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Dyslipidemias; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: RC02T001; 2023-510369-92 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No