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

Status and phase

Completed

Phase 1

Conditions

Overweight

Obesity

Treatments

Drug: NNC0487-0111 (formulation C)

Drug: NNC0487-0111 (formulation D)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06478563

U1111-1300-3720 (Other Identifier)

NN9487-7980

Details and patient eligibility

About

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).

Enrollment

133 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

133 participants in 4 patient groups

Phase A: NNC0487-0111 (formulation D)

Experimental group

Description:

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).

Treatment:

Drug: NNC0487-0111 (formulation D)

Phase A: NNC0487-0111 (formulation C)

Active Comparator group

Description:

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).

Treatment:

Drug: NNC0487-0111 (formulation C)

Phase B: NNC0487-0111 (formulation D)

Experimental group

Description:

Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D).

Treatment:

Drug: NNC0487-0111 (formulation D)

Phase B: NNC0487-0111 (formulation C)

Active Comparator group

Description:

Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C).