A Study to Investigate Efficacy and Safety of NNC0194-0499 Versus Placebo, Both Administered Alone or in Combination With Semaglutide in People With Type 1 Diabetes

Registration

Registration

NCT07087795

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

QUADRUPLE

Status

ACTIVE_NOT_RECRUITING

Enrollment

96

Start

2025-07-01

Primary completion

2026-09-12

Lead sponsor

Novo Nordisk A/S

Conditions

Diabetes Mellitus, Type 1

Interventions

DRUG:NNC0194-0499; DRUG:Placebo; DRUG:Semaglutide

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER:U1111-1315-5122; OTHER:2024-519533-38

Registered primary outcomes

• Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL) [From baseline (day -14 - -1) to day 36-49 / day 106-119]
• Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL) [From baseline (day -14 - -1) to day 92-105 / day 162-175]