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

Completed · Phase 1

Conditions studied: Obesity, Overweight

In brief

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 facts

Study ID

NCT06478563

Run by

Novo Nordisk A/S

People needed

133

Starts

2024-06-27

Expected to finish

2025-07-01

Last updated by the study team

2025-08-11

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion, Lincoln — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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