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

NCT06797401 | Recruiting Phase 2 DMC

• 2 other identifiers: RC02T0012023-510369-92
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Dyslipidemias

Keywords

Mixed dyslipidemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Frequency, intensity and seriousness of the AEs during the trial

  Each visit from baseline to week 48 (end of trial)

• Change from baseline in triglyceride (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

  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

  week 4, 8, 12, 16, 20, 24, 32, 40 and 48

Study Arms (3)

Low dose group

EXPERIMENTAL

Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84.

Drug: RBD5044; Drug: Placebo

Medium dose group

EXPERIMENTAL

Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84.

Drug: RBD5044; Drug: Placebo

High dose group

EXPERIMENTAL

Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84.

Drug: RBD5044; Drug: Placebo

Interventions

RBD5044 DRUG

RBD5044, active drug.

High dose group; Low dose group; Medium dose group

Placebo DRUG

Placebo that is identical in appearance and volume to the doses of active IMP.

High dose group; Low dose group; Medium dose group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ribocure Pharmaceuticals AB: lead

Study Sites (4)

Lunds Universitetssjukhus

Lund, Sweden

RECRUITING

Ribocure Clinic/Ribocure Pharmaceuticals AB

Mölndal, Sweden

RECRUITING

AkardoMedSite

Stockholm, Sweden

RECRUITING

Akademiska Sjukhuset Uppsala

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebeckha Magnusson

CONTACT

0046317207800; rebeckha.magnusson@ribocure.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (participant, care provider, investigator, outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: January 28, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)