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Phase 2RecruitingNCT06435156

SOPHIST: sotagliflozin for heart-failure symptoms in T1D

What this study tests

Recruiting UK Phase 2 of 16 weeks of sotagliflozin 200 mg daily versus placebo in adults with Type 1 diabetes and heart failure or high risk of heart failure. The primary endpoint is a heart-failure quality-of-life score, not HbA1c. No results.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-04-06.

Most recent recorded citation date: 2026-04-06. 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

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Adults 18–84 with T1D, either insulin at least 0.5 U/kg or BMI at least 25 kg/m², using or willing to use CGM, and heart failure or high HF risk (raised NT-proBNP, prior HF hospitalisation on loop diuretics, or LVEF below 50%). 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. Recruiting; estimated n=320; actual start 28 January 2025; estimated primary and study completion 31 October 2027. Last registry update 6 April 2026. Type 2 heart-failure sotagliflozin data do not score this Type 1 trial.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: United Kingdom. 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 in Kansas City Cardiomyopathy Questionnaire clinical summary score at 16 weeks

The full picture

SOPHIST is a Type 1-only heart-failure symptoms trial of sotagliflozin, funded with Lexicon and JDRF (Breakthrough T1D) involvement. It does not test a Type 1 glucose licence. The question is whether 16 weeks of 200 mg daily improves how people with T1D and heart failure feel, on the Kansas City Cardiomyopathy Questionnaire.

Participants must already use CGM or start one. Ketoacidosis remains the reason this class lost its European Type 1 indication: ketones can rise while glucose still reads in a typical target such as 70–180 mg/dL (3.9–10.0 mmol/L). No results are posted.

Sources

  1. [1]