ASPIRE-1: dApagliflozin SC0062 and Prevention of renal Injury; a Randomized Evaluation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Medical Center Groningen

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2026-02-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Juvenile Diabetes Research Foundation · Biocity Biopharmaceutics Co., Ltd.

External identifiers

EU CT number

2023-504404-28-00

ClinicalTrials.gov

NCT06072326

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To examine the effects of dapagliflozin and SC0062 compared to SC0062 alone on albuminuria in adults with T1D and chronic kidney disease with elevated urinary albumin excretion.

Secondary objectives 1

1. To examine the change from baseline in markers of fluid retention (body weight, hemoglobin, N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP)), Extracellular Volume (ECV), blood pressure, and estimated glomerular filtration rate (eGFR)when treated with SC0062 or dapagliflozin alone versus combination of dapagliflozin and SC0062. Safety: To assess the incidence, severity and seriousness of adverse events during treatment with SC0062 and/or dapagliflozin.

Conditions and MedDRA coding

Chronic Kidney Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Willing and able to sign informed consent
2. Male or female individuals diagnosed with type 1 diabetes at least 6 months prior to informed consent
3. Women of Childbearing Potential (WOCBP) must have a negative pregnancy test at screening and must not be lactating.
4. Male individuals must use highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 weeks after the last dose of study medication, or be able to provide proof of vasectomy.
5. Female individuals must use highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 weeks after the last dose of study medication, provide proof of hysterectomy or sterilization, or be deemed menopausal based on a FSH-test.
6. Age ≥18 and <65years, at the time of signing consent.
7. Body Mass Index ≥ 21 kg/m2
8. Urinary albumin:creatinine ratio ≥ 50 mg/g and <3000 mg/g
9. eGFR ≥ 30 and <90 ml/min/1.73m2
10. Stable RAAS inhibition medication for at least 4 weeks prior to screening
11. HbA1c ≥6.5 and ≤10.5%
12. Based on the Investigator’s judgment participant must have a good understanding of his/her disease and how to manage it, and be willing and capable of performing the following study assessments (assessed before randomization): patient-led management and adjustment of insulin therapy; reliable approach to insulin dose adjustment for meals, such as carbohydrate counting; reliable and regular home-based blood glucose monitoring; established “sick day” management regimen

Exclusion criteria 13

1. Diagnosis of type 2 diabetes, or other types of diabetes (e.g. LADA)
2. Hemoglobin < 90 g/L
3. Diagnosis of severe edema (per investigator judgment) within 3 months of screening
4. Diagnosis of heart failure (NYHC stage III or IV)
5. Treatment with an anti-hyperglycaemic agent (e.g., metformin, alpha-glucosidase inhibitors, pramlintide, glucagon-like peptide receptor agonist, etc.) within 3 months
6. Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months
7. Hypoglycaemia unawareness based on Investigator judgement or frequent episodes of unexplained hypoglycaemia (2 or more unexplained episodes within 3 months)
8. Occurrence of diabetic ketoacidosis within 6 months prior to study enrolment
9. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 6 months
10. Any other clinical condition that, based on Investigator’s judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g., immunocompromised patients, patients who might be at higher risk of developing urinary, genital or mycotic infections, patients with chronic viral infections, etc.)
11. Treatment with an SGLT2i within 30 days of Visit 1
12. NT-proBNP > 600 pg/mL
13. Strong CYP3A4 inducers or strong CYP3A4 inhibitors

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062.

Secondary endpoints 1

1. Change from baseline in markers of fluid retention (body weight, hemoglobin, N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP)), Extracellular Volume (ECV), blood pressure, and estimated glomerular filtration rate (eGFR)when treated with SC0062 or dapagliflozin alone versus combination of dapagliflozin and SC0062. Safety: To assess the incidence, severity and seriousness of adverse events during treatment with SC0062 and/or dapagliflozin.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Medical Center Groningen

Sponsor organisation

University Medical Center Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

University Medical Center Groningen

Contact name

Hiddo Lambers-Heerspink

Public contact point

Organisation

University Medical Center Groningen

Contact name

Hiddo Lambers-Heerspink

Locations

3 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications