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

Novo Nordisk A/S133 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

133

Conditions

Obesity Overweight

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state

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

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

Secondary Outcomes

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

Measured as nanomoles per liter (nmol/L)

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

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

Measured as hours

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

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

Measured as h\*nmol/L

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

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

Measured as nmol/L

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

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

Measured as hours

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

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

Measured as hours

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

Number of treatment emergent adverse events (TEAE)

Measured as number of events

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes