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NC-503

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Trials Updated: Aug 24, 2010

NC-503 target and mechanism

ModalitySmall molecule

Also known as NC-503 (eprodisate disodium)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment350

FDA Designations

No designations recorded

NC-503 clinical trials

NC-503 · 2 trials · 8 indications

Phase 2 2
NCT00675857A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II DiabetesDiabetes Mellitus, Type 2
COMPLETED200 Analytics
NCT00035334Study of the Safety and Efficacy of NC-503 in Secondary (AA) AmyloidosisSecondary (AA) Amyloidosis
COMPLETED150 Analytics
PHASE2COMPLETED
A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE2COMPLETED
Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
Secondary (AA) AmyloidosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline to Week 26 in HbA1c levels
26 weeks

Secondary Endpoints

Change in HbA1c levels
26 weeks
The rate of achieving glycemic control
26 weeks
Change in fasting serum glucose levels
26 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
APLACEBO_COMPARATOR -
BACTIVE_COMPARATOR -

Interventions

NameTypeDescription
NC-503 (eprodisate disodium)DRUGcapsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
placeboOTHERDosage: 4 capsules BID for 26 weeks
NC-503 (Anti-amyloidotic (AA) Agent)DRUG -
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Eligibility Criteria

Age Range30 Years to 95 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Age and gender eligibility: 30 years and older * Diagnosis of Type 2 diabetes mellitus * Patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to t...

Countries:CanadaUnited StatesFinlandFranceIsraelItalyLithuaniaNetherlandsPolandRussiaSpainTurkey (Türkiye)United Kingdom
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Frequently asked questions about NC-503

What is NC-503?

NC-503 is an investigational small molecule developed by GSK plc for metabolic disease. It has been studied in Type 2 diabetes mellitus and metabolic syndrome. Development reached Phase 2, and the compound is also known as eprodisate disodium. It is not an approved therapy and remains a clinical-stage research asset.

What is NC-503 used for in Type 2 diabetes?

NC-503 was studied as a treatment for Type 2 diabetes mellitus and metabolic syndrome. The Phase 2a proof-of-concept trial enrolled adults aged 30 years and older with Type 2 diabetes. The program is investigational, so NC-503 is not an approved treatment for Type 2 diabetes or any other condition.

Who makes NC-503?

NC-503 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 2a proof-of-concept study of NC-503 in patients with Type 2 diabetes. The asset is also referred to as eprodisate disodium.

What phase is NC-503 in?

NC-503 reached Phase 2 clinical development. One Phase 2a proof-of-concept trial in Type 2 diabetes has been completed, and no trials are currently active. NC-503 is investigational and has not been approved by the FDA for any indication.

What clinical trials is NC-503 in?

NC-503 has been evaluated in one completed Phase 2a trial, NCT00675857, titled a Phase IIa proof-of-concept study of NC-503 in patients with Type II diabetes. The randomized, double-blind, placebo-controlled study enrolled 200 participants in Canada and included patients with Type 2 diabetes and metabolic syndrome.

Is NC-503 the same as eprodisate disodium?

Yes, NC-503 is also known as eprodisate disodium. Both names refer to the same investigational small molecule developed by GSK plc for metabolic indications, including Type 2 diabetes mellitus. Searches for either name point to the same Phase 2 clinical program.