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NCT Number: NCT06478563

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

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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Lincoln

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Age 18-64 years (both inclusive)
  • Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m^2) (both inclusive)
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
  • Vitamin D (25-hydroxycholecalciferol) less than (<) 12 ng/mL (30 Nanometer (nM)) at screening
  • Parathyroid hormone (PTH) outside normal range at screening
  • Total calcium outside normal range at screening
  • Calcitonin greater than or equal to (≥) 50 pg/mL at screening
  • Amylase greater than or equal to (≥) 2 times upper limit of normal
  • Lipase greater than or equal to (≥) 2 times upper limit of normal
  • Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening

Treatment and study plan

NNC0487-0111 (formulation D)

Drug

Participants will receive NNC0487-0111 (formulation D) tablet once daily.

NNC0487-0111 (formulation C)

Drug

Participants will receive NNC0487-0111 (formulation C) tablet once daily.

Primary outcomes

  1. 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

    Measured as hours*nanomoles per liter (h*nmol/L)

Secondary outcomes

  1. Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state

    Time frame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126

    Measured as nanomoles per liter (nmol/L)

  2. Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state

    Time frame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126

    Measured as hours

  3. Phase B: The area under the NNC0487-0111 plasma concentration-time curve

    Time frame: From pre-dose to after dosing on day 132

    Measured as h*nmol/L

  4. Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose

    Time frame: From pre-dose to after dosing on day 132

    Measured as nmol/L

  5. Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose

    Time frame: From pre-dose to after dosing on day 132

    Measured as hours

  6. Phase B:The terminal half-life of NNC0487-0111 after the last dose

    Time frame: From pre-dose on day 132 until completion of the end of study visit (day 153)

    Measured as hours

  7. Number of treatment emergent adverse events (TEAE)

    Time frame: From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153)

    Measured as number of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigating the Exposure of NNC0487-0111 in Different Oral Formulations and the Effect of Food Intake on Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2024
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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