A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Placebo (NNC0487-0111); Drug: NNC0487-0111

Study type: Interventional

Funder types: Industry

Identifiers

NCT06820476

NN9487-7573

U1111-1289-3164 (Other Identifier)

Details and patient eligibility

About

The study is testing a new study medicine called NNC0487-0111 for weight control in Chinese people with Body mass index (BMI) greater than or equal to (>=) 24 kilogram per square meter (kg/m^2). The aim of this study is to find out how safe the study medicine is and how it behaves in your body. Participants will either get NNC0487-0111 or placebo. Which treatment participants will 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 60 days.

Enrollment: 29 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 24.0 and 34.9 kilogram per square meter (kg/m^2)(both inclusive), with a body weight greater than or equal to (>=) 65.0 kilogram (kg), at screening.
• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

• Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
• Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening
• 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 Nanograms per millilitre (ng/mL) (30 nanometer[nM]) at screening
• Parathyroid hormone (PTH) outside normal range at screening
• Total calcium outside normal range at screening
• Amylase greater than or equal to (>=) 2 times upper limit of normal at screening
• Lipase greater than or equal to (>=) 2 times upper limit of normal at screening
• Calcitonin greater than or equal to (>=) 50 picograms per milliliter (pg/mL) at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 4 patient groups, including a placebo group

NNC0487-0111 (dose 1)

Experimental group

Description:

Participants will be randomized to receive a single dose of NNC0487-0111.

Treatment:

Drug: NNC0487-0111

NNC0487-0111 (dose 2)

Experimental group

Description:

Participants will be randomized to receive a single dose of NNC0487-0111.

Treatment:

Drug: NNC0487-0111

NNC0487-0111 (dose 3)

Experimental group

Description:

Participants will be randomized to receive a single dose of NNC0487-0111.

Treatment:

Drug: NNC0487-0111

Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive matching Placebo to NNC0487-0111.

Treatment:

Drug: Placebo (NNC0487-0111)