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RecruitingNCT06797401Updated Sep 10, 2026

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

A Phase 2 interventional study of RBD5044 and Placebo in Dyslipidemias, sponsored by Ribocure Pharmaceuticals AB. Recruiting at 4 sites in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Ribocure Pharmaceuticals AB · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dyslipidemias

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Keywords

  • Mixed dyslipidemia
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Low dose group

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

    Drug: RBD5044 · Drug: Placebo

  • Experimental
    Medium dose group

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

    Drug: RBD5044 · Drug: Placebo

  • Experimental
    High dose group

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

    Drug: RBD5044 · Drug: Placebo

Interventions

  • DrugRBD5044

    RBD5044, active drug.

  • DrugPlacebo

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

05

What researchers measure

Primary outcomes

  1. Change 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Plasma concentrations of RBD5044

    Time frame: In conjunction of administration of the IMP

  5. 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

06

Study locations

4 of 4 sites recruiting
  • Lunds Universitetssjukhus
    Lund, Sweden
    • David Erlinge, MD, PhD · Contact
    Recruiting
  • Ribocure Clinic/Ribocure Pharmaceuticals AB
    Mölndal, Sweden
    • Sara Svedlund, MD, PhD · Contact
    Recruiting
  • AkardoMedSite
    Stockholm, Sweden
    • Åke Olsson, MD, PhD · Contact
    Recruiting
  • Akademiska Sjukhuset Uppsala
    Uppsala, Sweden
    • Emil Hagström, MD, PhD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06797401
Lead sponsor
Ribocure Pharmaceuticals AB
Responsible party
Sponsor
First posted
Jan 28, 2025
Start date
Jan 28, 2025
Primary completion
May 31, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Rebeckha Magnusson
Contact
rebeckha.magnusson@ribocure.com
0046317207800
Sara Svedlund, MD, PhD
principal investigator · Ribocure Clinic/Ribocure Pharmaceuticals AB
David Erlinge, MD, PhD
principal investigator · Lunds Universitetssjukhus
Emil Hagström, MD, PhD
principal investigator · Akademiska Sjukhuset Uppsala
Åke Olsson, MD, PhD
principal investigator · AkardoMedSite

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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