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 (part of Suzhou Ribo Life Science Co., Ltd.) · Phase 2, Interventional, and Treatment
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Among 33 studies in Dyslipidemias with a site in Sweden — 5 open to participants now, 9 under way, 2 of them phase 3. Dyslipidemias · Sweden.
Among the 33 studies in Dyslipidemias with a site in Sweden, this one is the 21st largest by planned enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2025, is one of 6 in phase 2, and was the 31st registered.
1,249 studies on the registry are indexed under Dyslipidemias; 177 are open to participants now.
Browse Dyslipidemias studies →5 of the 33 studies in Dyslipidemias with a site in Sweden are open now. Recruiting first, the newest first:
Johan Sundström · Sites in Sweden
Ages 50–75 · Healthy volunteers
University Hospital, Linkoeping · Sites in Sweden
Ages 18–50 · Healthy volunteers
Newcastle University · Sites in Sweden, Belgium, Finland and 9 more countries
Ages 18–100
Karolinska University Hospital · Sites in Sweden
Ages 18–65
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 112 Dyslipidemias studies recruiting now, 55 (49%) set no upper age limit and 36 (32%) stop at 75 or younger; 11 take children under 18; 29 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 100 across 986 interventional studies indexed under Dyslipidemias.
Median enrollment 419 across the 28 interventional studies, 1,950 across the 5 observational. Of the 24 that completed or were terminated, 10 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 33 have an industry lead sponsor. The 10 most frequent:
This study is registered under Ribocure Pharmaceuticals AB, one of the names counted as Suzhou Ribo Life Science Co., Ltd.. Under that name alone:
Ribocure Pharmaceuticals AB is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Suzhou Ribo Life Science Co., Ltd. has 1 study filed under Dyslipidemias — fewer than ten, so there is no comparison to draw.
2 of the studies in Dyslipidemias with a site in Sweden that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05030428Phase 3Novartis PharmaceuticalsStudy of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease | 2027-05-10 |
| NCT06797401Ribocure Pharmaceuticals ABPhase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia | 2027-05-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 33 studies in Dyslipidemias with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Hepatic: or AST >2× at screening, \<30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease [MDRD] equation) at Screening, >9.0% (or >75 mmol/mol International Federation of Clinical Chemistry [IFCC] units) at screening.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84.
Drug: RBD5044 · Drug: Placebo
Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84.
Drug: RBD5044 · Drug: Placebo
Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84.
Drug: RBD5044 · Drug: Placebo
RBD5044, active drug.
Placebo that is identical in appearance and volume to the doses of active IMP.
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
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)
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
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
Plasma concentrations of RBD5044
Time frame: 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
Time frame: week 4, 8, 12, 16, 20, 24, 32, 40 and 48
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for May 2027, 28 months after the start.
Of 35 industry-sponsored phase 2 interventional studies under Dyslipidemias, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's planned 28 months is above that.
Counting every sponsor, half of 43 studies reached it within 13 months; a quarter within 7 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: RBD5044