Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia
NCT06797401 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-03-12
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
Interventions
- DRUG
-
RBD5044
RBD5044, active drug.
- DRUG
-
Placebo that is identical in appearance and volume to the doses of active IMP.
Sponsors & Collaborators
-
Ribocure Pharmaceuticals AB
lead INDUSTRY
Principal Investigators
-
Sara Svedlund, MD, PhD · Ribocure Clinic/Ribocure Pharmaceuticals AB
-
David Erlinge, MD, PhD · Lunds Universitetssjukhus
-
Emil Hagström, MD, PhD · Akademiska Sjukhuset Uppsala
-
Åke Olsson, MD, PhD · AkardoMedSite
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-28
- Primary Completion
- 2026-05-31
- Completion
- 2026-09-30
Countries
- Sweden
Study Locations
More Related Trials
-
A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia
NCT00231621 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight
NCT07232719 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
NCT05882045 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight
NCT05209984 ·Status: WITHDRAWN ·Phase: PHASE3
-
Study to Assess the Safety and Tolerability of Single Doses of REGN1500
NCT01749878 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)
NCT06548100 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
NCT05713799 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity
NCT03015207 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects
NCT01866748 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
NCT05931367 ·Status: COMPLETED ·Phase: PHASE3
-
Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
NCT06471543 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
NCT06579092 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
NCT06047548 ·Status: COMPLETED ·Phase: PHASE3
-
Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity
NCT03013543 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
NCT05970640 ·Status: COMPLETED ·Phase: PHASE1
-
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin
NCT06064006 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension
NCT02639286 ·Status: COMPLETED ·Phase: PHASE2
-
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight
NCT02958085 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.
NCT02717858 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia
NCT06555640 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
NCT05929079 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
NCT06373146 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists
NCT06640972 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities
NCT06277934 ·Status: COMPLETED ·Phase: PHASE2
-
Study of MAR001 in Adults With Metabolic Dysfunction
NCT05896254 ·Status: COMPLETED ·Phase: PHASE1/PHASE2