NNC0194-0499 (zalfermin) ± semaglutide in adults with T1D
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.
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
Results so far
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.
The full picture
NNC0194-0499 is zalfermin, a lipidated FGF21 analogue. This trial is Type 1 only: adults on insulin, time in range 3.9–10.0 mmol/L (70–180 mg/dL) as the primary. It is not an approval study, not a Type 2 study, and not scored from the failed NASH fibrosis trial. No ranked item is added until there is a posted Type 1 result or a registered Type 1 late-stage programme.