A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body of Participants Living With Overweight or Obesity

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Novo Nordisk A/S
Study ID
NCT06478563
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).

Key Dates

Start date
Jun 27, 2024
Status verified
Aug 2025
Primary completion
Jun 5, 2025
Completion
Jul 1, 2025

Study Design

Enrollment
133 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase A: NNC0487-0111 (formulation D)
    Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks).
  • Active Comparator: Phase A: NNC0487-0111 (formulation C)
    Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks).
  • Experimental: Phase B: NNC0487-0111 (formulation D)
    Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D).
  • Active Comparator: Phase B: NNC0487-0111 (formulation C)
    Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C).

Primary Outcome Measure

Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state [ Time Frame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126 ]

Locations (1)

FacilityCityStateZIP
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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