DyslipidemiasPhase 2NCT06797401
Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia
A Phase 2 study testing RBD5044 in people with Dyslipidemias, run by Ribocure Pharmaceuticals AB at 4 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- RBD5044
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesSweden
- Study dates
- 28 Jan 2025to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Lunds Universitetssjukhus
Lund
David Erlinge, MD, PhD
- Recruiting
Ribocure Clinic/Ribocure Pharmaceuticals AB
Mölndal
Sara Svedlund, MD, PhD
- Recruiting
AkardoMedSite
Stockholm
Åke Olsson, MD, PhD
- Recruiting
Akademiska Sjukhuset Uppsala
Uppsala
Emil Hagström, MD, PhD
About this study
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
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.
- Conditions
- Dyslipidemias
- Being tested
- RBD5044, Placebo
- Keywords
- Mixed dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD5044Drug
RBD5044, active drug.
PlaceboDrug
Placebo that is identical in appearance and volume to the doses of active IMP.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84. Receives: Drug: RBD5044; Drug: Placebo |
| Medium dose group | Experimental | Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84. Receives: Drug: RBD5044; Drug: Placebo |
| High dose group | Experimental | Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84. Receives: Drug: RBD5044; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in triglyceride (TG) levels at week 16
Percent change from baseline in TG levels at week 16.
Measured: From baseline until end week 16
Secondary outcomes (5)
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).
Measured: 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
Measured: 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
Measured: week 4, 8, 12, 20, 24, 32, 40 and 48
Plasma concentrations of RBD5044
Measured: 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
Measured: week 4, 8, 12, 16, 20, 24, 32, 40 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start28 Jan 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ribocure Pharmaceuticals AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Svedlund, MD, PhD, Principal investigator, Ribocure Clinic/Ribocure Pharmaceuticals ABDavid Erlinge, MD, PhD, Principal investigator, Lunds UniversitetssjukhusEmil Hagström, MD, PhD, Principal investigator, Akademiska Sjukhuset UppsalaÅke Olsson, MD, PhD, Principal investigator, AkardoMedSite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797401
- Sponsor's protocol ID
- RC02T001
- Other IDs
- 2023-510369-92, 2023
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06797401
- Acronym / sponsor ID
- RC02T001
- Conditions
- Dyslipidemias
- Keywords
- Mixed dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ribocure Pharmaceuticals ABIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: RBD5044, Drug: PlaceboParticipants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84. |
| Medium dose group | Experimental | Drug: RBD5044, Drug: PlaceboParticipants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84. |
| High dose group | Experimental | Drug: RBD5044, Drug: PlaceboParticipants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBD5044RBD5044, active drug. | Drug | High dose group, Low dose group, Medium dose group |
| PlaceboPlacebo that is identical in appearance and volume to the doses of active IMP. | Drug | High dose group, Low dose group, Medium dose group |
Primary outcome
Change from baseline in triglyceride (TG) levels at week 16
Time frame: From baseline until end week 16
Percent change from baseline in TG levels at week 16.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBD5044 in people with Dyslipidemias, run by Ribocure Pharmaceuticals AB at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebeckha Magnusson (0046317207800, rebeckha.magnusson@ribocure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in triglyceride (TG) levels at week 16 (time frame: From baseline until end week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.