ASPIRE-1: endothelin-A antagonist SC0062 and dapagliflozin alone and combined in T1D with chronic kidney disease
What this study tests
A randomized, open-label phase 2 crossover study in Europe evaluating 4-week treatment periods of the selective endothelin-A receptor antagonist SC0062 (20 mg/day), dapagliflozin (5 mg/day), and their combination on albuminuria (UACR) in adults with T1D and chronic kidney disease.
Editorial review: .
Registry checked: 2026-10-19. Registry’s own update: 2025-10-07.
Most recent recorded citation date: 2026-10-13. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged 18–64 years with T1D for at least 6 months, BMI at least 21 kg/m², UACR 50 to under 3000 mg/g, eGFR 30 to under 90 mL/min/1.73 m², stable RAAS inhibition, and HbA1c 6.5%–10.5%; DKA within 6 months and severe hypoglycemia within 3 months are excluded. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. Registry checked 19 October 2026 (EU CTIS 2026-525684-40-01 authorised in Finland 9 October 2026 and Denmark 12 October 2026, published 13 October 2026; ClinicalTrials.gov NCT06072326 last updated 7 October 2025): not yet recruiting on ClinicalTrials.gov; estimated n=36; estimated primary completion December 2027.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Change from baseline in Urine Albumin-Creatinine Ratio (UACR) at 4 weeks (SC0062 alone vs combination dapagliflozin + SC0062)
The full picture
What the study asks
ASPIRE-1 is a randomized, open-label phase 2 crossover study led by University Medical Center Groningen (in collaboration with Breakthrough T1D and Biocity Biopharmaceutics) evaluating whether combining the selective endothelin-A receptor antagonist SC0062 (10 mg twice daily) with low-dose dapagliflozin (5 mg once daily) lowers albuminuria (UACR) more than monotherapy over 4-week treatment periods in adults with type 1 diabetes and chronic kidney disease.12
Who it involves
Adults aged 18–64 years with type 1 diabetes for at least 6 months, body mass index at least 21 kg/m², urine albumin-creatinine ratio (UACR) between 50 and under 3,000 mg/g, eGFR between 30 and under 90 mL/min/1.73 m², HbA1c 6.5%–10.5%, and stable renin-angiotensin-aldosterone system (RAAS) inhibition. Individuals with diabetic ketoacidosis within 6 months or severe hypoglycemia within 3 months are excluded.12
Design and timing
The trial plans 36 participants across seven clinical sites in Denmark, Finland, and the Netherlands. On EU CTIS (2026-525684-40-01), the protocol was authorised in October 2026 (2026-10-09 in Finland, 2026-10-12 in Denmark, published 2026-10-13), while ClinicalTrials.gov (NCT06072326) still lists NOT_YET_RECRUITING (registryUpdated: 2025-10-07). Estimated primary completion is December 2027 and study completion is December 2028.12
Evidence and limits
No results are posted. A 4-week crossover study measuring surrogate albuminuria changes cannot establish long-term kidney outcome protection or rule out diabetic ketoacidosis risk from SGLT2 inhibition in type 1 diabetes.12
Sources
- [1]Albuminuria Lowering With an SGLT2 Inhibitor and an Endothelin Receptor Antagonist in Type 1 Diabetes (ASPIRE-1, NCT06072326) · Trial registry · 2025-10-07 — ClinicalTrials.gov record checked 19 October 2026: NOT_YET_RECRUITING; estimated n=36; last update posted 7 October 2025.
ClinicalTrials.gov. NCT06072326. Record checked 19 October 2026; last update posted 2025-10-07.
- [2]ASPIRE-1 EU Clinical Trials Information System Record (2026-525684-40-01) · Trial registry · 2026-10-13 — Authorised in Finland (9 October 2026) and Denmark (12 October 2026) and published 13 October 2026 on EU CTIS across 7 sites in Denmark, Finland, and the Netherlands; checked 19 October 2026.
EU Clinical Trials Information System (CTIS). EUCT 2026-525684-40-01 (ASPIRE-1). Published 13 October 2026; checked 19 October 2026.