Investigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT07535307
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NNC0487-0111 — DRUG
    NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen.
  • Placebo — DRUG
    Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen.

Study Details

The purpose of this clinical study is to find out how NNC0487-0111 affects, how the body uses insulin (a hormone that helps the body control blood sugar) and how well the pancreas works in people living with type 2 diabetes. There are 2 study treatments. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Nov 11, 2027
Completion
Dec 6, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC0487-0111 dose level 1
    Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly.
  • Experimental: NNC0487-0111 dose level 2
    Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly.
  • Experimental: NNC0487-0111 dose level 3
    Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly.
  • Placebo Comparator: Placebo
    Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly.

Primary Outcome Measure

Change in M-value in Hyperinsulinaemic euglycaemic clamp (HEC) [ Time Frame: Baseline to week 40 ]

Central Contacts

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