A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT07087795
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • NNC0194-0499 — DRUG
    Participants will receive subcutaneous NNC0194-0499 once weekly.
  • Placebo — DRUG
    Participants will receive placebo matched to NNC0194-0499 subcutaneously.
  • Semaglutide — DRUG
    Participants will receive subcutaneous semaglutide once weekly.

Study Details

This study is testing the effect of a new study medicine NNC0194-0499 in type 1 diabetes. The purpose of the study is to compare the effect of NNC0194-0499 on the blood sugar levels of participants with type 1 diabetes when taken in combination with semaglutide or placebo. All participants will receive standard of care insulin treatment. The study will last for about 36 weeks.

Key Dates

Start date
Jul 1, 2025
Status verified
Mar 2026
Primary completion
Sep 12, 2026
Completion
Sep 25, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: NNC0194-0499/Placebo
    After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo.
  • Experimental: Part B: NNC0194-0499/Placebo + Semaglutide
    After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide.

Primary Outcome Measure

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

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