A Research Study Investigating the Effect of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and Participants With Type 1 Diabetes With Overweight or Obesity

Sponsor
Novo Nordisk A/S
Study ID
NCT07578584
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • NNC0497-0040 — DRUG
    NNC0497-0040 will be administered subcutaneously.
  • Placebo — DRUG
    Placebo will be administered subcutaneously.

Study Details

The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.

Key Dates

First listed
May 11, 2026
Start date
May 7, 2026
Status verified
May 2026
Primary completion
Feb 18, 2028
Completion
Feb 18, 2028

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SAD
    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
  • Experimental: MAD1
    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
  • Experimental: MAD2
    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
  • Experimental: MAD3
    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
  • Experimental: MAD4
    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

Primary Outcome Measure

Number of adverse events [ Time Frame: Day 1 up to Week 6 ]

Central Contacts

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