NCT06797401 Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia
| NCT ID | NCT06797401 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ribocure Pharmaceuticals AB |
| Condition | Dyslipidemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-01-28 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-01-28 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Sara Svedlund, MD, PhD
PRINCIPAL INVESTIGATOR
Ribocure Clinic/Ribocure Pharmaceuticals AB
Frequently Asked Questions
Who can join the NCT06797401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Dyslipidemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06797401 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06797401 currently recruiting?
Yes, NCT06797401 is actively recruiting participants. Contact the research team at rebeckha.magnusson@ribocure.com for enrollment information.
Where is the NCT06797401 trial being conducted?
This trial is being conducted at Lund, Sweden, Mölndal, Sweden, Stockholm, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT06797401 clinical trial?
NCT06797401 is sponsored by Ribocure Pharmaceuticals AB. The principal investigator is Sara Svedlund, MD, PhD at Ribocure Clinic/Ribocure Pharmaceuticals AB. The trial plans to enroll 120 participants.