NNC0194-0499 (zalfermin) ± semaglutide in adults with T1D
What this study tests
Novo Nordisk Phase 1 crossover in adults with established T1D, testing weekly NNC0194-0499 (zalfermin, an FGF21 analogue) versus placebo, alone or on top of weekly semaglutide, with insulin continuing. Active, not recruiting. No results posted. Novo discontinued zalfermin plus semaglutide in NASH; that is not a Type 1 result and does not by itself close this T1D study.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-08-13.
Most recent recorded citation date: 2026-08-13. 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 18–64 with T1D for at least one year, on multiple daily injections with a stable insulin dose for more than 90 days, CGM for more than 180 consecutive days, HbA1c 7.2–9.0%. BMI 22–35 kg/m² in Part A and 27–35 in Part B. GLP-1 receptor agonists within 90 days, recurrent severe hypoglycaemia, and recent DKA 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. Active, not recruiting; estimated n=96; actual start 1 July 2025; estimated primary completion 12 September 2026. Last registry update 13 August 2026. Single listed site: Neuss, Germany. The registry parenthetical “70–80 mg/dL” next to 3.9–10.0 mmol/L is a unit-conversion error; 10.0 mmol/L is 180 mg/dL, the usual T1D time-in-range band. Novo discontinued zalfermin plus semaglutide in NASH after a Phase 2 miss; this T1D protocol remains ACTIVE_NOT_RECRUITING. Type 2 / NASH evidence does not score this record.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 in time in range 3.9–10.0 mmol/L (70–180 mg/dL) in Part A and separately in Part B
The full picture
NNC0194-0499 is zalfermin, identified as an FGF21 analogue in the EMA notice. This trial is Type 1 only: adults on insulin, with change in time in range 3.9–10.0 mmol/L (70–180 mg/dL) as the registry-listed primary in each part. It is a Phase 1 study, not a Type 2 study, and the EMA notice records the zalfermin plus semaglutide NASH programme as discontinued after missing its fibrosis primary endpoint — a NASH decision, not a T1D result. No ranked item is added until there is a posted Type 1 result or a registered Type 1 late-stage programme.
Sources
- [1]NCT07087795: NNC0194-0499 versus placebo, alone or with semaglutide, in people with Type 1 Diabetes · Trial registry · 2026-08-13
- [2]Notification of discontinuation of paediatric development — zalfermin (NNC0194-0499) / semaglutide (NASH programme) · Regulatory decision · 2026-01-15 — EMA PIP discontinuation notice states the zalfermin plus semaglutide programme in NASH did not meet its fibrosis primary endpoint and was discontinued. That is a NASH decision, not a posted T1D result.