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R3R01

Phase 2

Diabetic Kidney Disease | Small molecule | Nephrology |IQVIA Holdings, Inc.|Last Updated: Jun 29, 2026

Development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Mar 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

R3R01 · 1 trial · 1 indication

Phase 2 1
NCT06600412The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.Diabetic Kidney Disease
RECRUITING60 Analytics
PHASE2RECRUITING
The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.
Diabetic Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Urinary albumin-to-creatinine ratio (UACR)
12 weeks (84 days)

Urinary albumin-to-creatinine ratio (UACR) (Change from baseline to end of treatment at 12 weeks (84 days).

Secondary Endpoints

Measured or Estimated Glomerular Filtration Rate
12 weeks (84 days)
24 hours ambulatory blood pressure
12 weeks (84 days)
Plasma Pharmacokinetics
24 weeks (168 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
R3R01EXPERIMENTALR3R01 oral tablet (200 mg twice daily) for 12 weeks
PlaceboPLACEBO_COMPARATORPlacebo oral tablet twice daily for 12 weeks

Interventions

NameTypeDescription
R3R01DRUGR3R01 is an ATP-binding cassette transporter A1 (ABCA1) inducer, which increases the efflux of cholesterol from the intracellular space in the kidney. Please refer to arm/group description for further information.
PlaceboDRUGPlease refer to arm/group description for further information.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Adults (above 18 years of age) with controlled type 2 diabetes (hemoglobin A1c less than 10.5%). 2. Stable antihypertensive treatment 4 weeks before start of study drug and throughout study duration. 3. Titrated to the maximal dose or maximal tolerated dose of renin-angiotens...

Countries:Denmark
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