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SC0062 low dose

Phase 2

Diabetic Kidney Disease | Small molecule | Nephrology |Co-Diagnostics, Inc.|Last Updated: Jan 7, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment255
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05687890A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney DiseasePHASE2 ACTIVE NOT_RECRUITING 255May 23, 2023Apr 1, 2025Jan 7, 20251 China
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Study Endpoints
Primary Endpoints
Change in urine albumin creatinine ratio (UACR)
Week 12

Change from baseline at Week 12 in urine albumin creatinine ratio (UACR) in Cohort 1

Changes in urine protein creatinine ratio (UPCR)
Week 12

Change from baseline at Week 12 in urine protein creatinine ratio (UPCR) in Cohort 2

Secondary Endpoints
Change in urine albumin creatinine ratio (UACR) by visit
Week 2, week 4, week 8, week 12, week 16, week 20, week 24
Change in urine protein creatinine ratio (UPCR) by visit
Week 2, week 4, week 8, week 12, week 16, week 20, week 24
Changes in glomerular filtration rate (eGFR)
Week 2, week 4, week 8, week 12, week 16, week 20, week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SC0062 low dose groupEXPERIMENTALSubjects will take two capsules daily for 24 weeks during the treatment period
SC0062 medium dose groupEXPERIMENTALSubjects will take two capsules daily for 24 weeks during the treatment period
SC0062 high dose groupEXPERIMENTALSubjects will take two capsules daily for 24 weeks during the treatment period
Placebo of SC0062 groupPLACEBO_COMPARATORSubjects will take two capsules daily for 24 weeks during the treatment period
Interventions
NameTypeDescription
Placebo of SC0062DRUGSubjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period
SC0062 low doseDRUGSubjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period
SC0062 medium doseDRUGSubjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period
SC0062 high doseDRUGSubjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Sign the informed consent voluntarily, and fully understand and comply with the relevant procedures of the test; 2. Age of ≥ 18 years old, gender is not limited; 3. Patients with chronic kidney disease (CKD) stage G1\~G3 with albuminuria, requirements: 1. eGFR ≥ 30 mL/min...

Countries:China
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