A First-in-human Research Study on How NNC0662-0419 Works in People Living With Overweight or Obesity

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Novo Nordisk A/S
Study ID
NCT06737536
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • NNC0662-0419 — DRUG
    Participants will receive NNC0662-0419 subcutaneous (s.c.) once weekly.
  • Placebo (NNC0662-0419) — OTHER
    Participants will receive placebo matched to NNC0662-0419 s.c. once weekly.

Study Details

This study is testing a new study medicine which may be used to treat people living with overweight or obesity. The purpose of the study is to see if the new study medicine is safe, how it works in human body and what human body does to the study medicine. Participants will either get the study medicine NNC0662-0419 or placebo (a "dummy" medicine without any active ingredients) given by study staff as an injection under participants skin. Which treatment participants will get is decided by chance. NNC0662-0419 is a new medicine, which cannot be prescribed by doctors. This is the first time the medicine is being given to humans. The study will last for about 9 months.

Key Dates

Start date
Dec 18, 2024
Status verified
Sep 2025
Primary completion
Jul 26, 2025
Completion
Jul 26, 2025

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Single ascending dose (SAD)
    Participants will receive a single dose of any of the five different dose levels of NNC0662-0419 or matching placebo in a sequential manner with the dose increasing between cohorts.
  • Experimental: Part B: Multiple ascending dose (MAD)
    Participants will receive NNC0662-0419 once-weekly for 4 weeks at any of the four different dose levels or matching placebo in a sequential manner with the dose increasing between cohorts.

Primary Outcome Measure

Part A: Number of treatment emergent adverse events (TEAE) [ Time Frame: From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, LincolnLincolnNebraska68502-

Find similar trials in Lincoln, NE

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Celerion, Lincoln· Lincoln, NE

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