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

NCT ID: NCT06820476

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-09

Study Completion Date

2025-05-14

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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NNC0487-0111 (dose 1)

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

Group Type EXPERIMENTAL

NNC0487-0111

Intervention Type DRUG

Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.

NNC0487-0111 (dose 2)

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

Group Type EXPERIMENTAL

NNC0487-0111

Intervention Type DRUG

Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.

NNC0487-0111 (dose 3)

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

Group Type EXPERIMENTAL

NNC0487-0111

Intervention Type DRUG

Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo (NNC0487-0111)

Intervention Type DRUG

Participants will be randomized to receive a placebo tablet orally matched to NNC0487-0111.

Interventions

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NNC0487-0111

Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.

Intervention Type DRUG

Placebo (NNC0487-0111)

Participants will be randomized to receive a placebo tablet orally matched to NNC0487-0111.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Jinan Central Hospital Affiliated to Shandong University

Ji'Nan, Shandong, China

Site Status

Jinan Central Hospital

Ji'Nan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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U1111-1289-3164

Identifier Type: OTHER

Identifier Source: secondary_id

NN9487-7573

Identifier Type: -

Identifier Source: org_study_id

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