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SCO-792 Phase 2a in Subjects with Type 2 Diabetes and Albuminuria.

A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison, Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of SCO-792 in Subjects with Type 2 Diabetes and Albuminuria.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080225017
Enrollment
75
Registered
2020-01-16
Start date
2020-06-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes and Albuminuria

Interventions

Sponsors

SCOHIA PHARMA, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -The subject signs and dates a written, informed consent form prior to the initiation of any study procedures -The subject is capable of understanding and complying with protocol requirements -The subject is either male or female and aged 18 to 75 years (inclusive) at signing of informed consent -The subject has been treated with stable doses of the same RAS inhibitors for at least 3 months prior to Visit 1 -The subject has been treated with stable doses of AHA monotherapy or combination therapy for at least 3 months prior to Visit 1 -The subject has UACR >=200 mg/gCr to <5000 mg/gCr -The subject has a HbA1c =< 10.5%

Exclusion criteria

Exclusion criteria: -The subject has a history of type 1 diabetes mellitus -The subject has a confirmed diagnosis of a renal disease other than type 2 DKD (eg, lupus nephritis, primary focal segmental glomerulosclerosis, acute or chronic glomerular nephritis, bilateral or unilateral renal artery stenosis or polycystic kidney disease). Concomitant hypertensive nephrosclerosis is not prohibited

Design outcomes

Primary

MeasureTime frame
safety exploratory -Incidence and severity of adverse events (AE) -Incidence of serious adverse events -Clinically significant changes from baseline in -Clinical laboratory tests -12-lead electrocardiograms -vital signs -physical examinations -Incidence and severity of hypoglycemia and hyperglycemia efficacy exploratory Change in log-transformed UACR from baseline at the ompletion of the treatment period (Week 12).

Secondary

MeasureTime frame
efficacy exploratory Change in eGFR value from baseline at the completion of the treatment period (Week 12). efficacy exploratory Responder rate (UACR decreased by>= 30%) from baseline at the completion of the treatment period (Week 12).

Countries

Oceania

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026