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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT06820476 (opens ClinicalTrials.gov in a new tab)Other idNN9487-7573Other idU1111-1289-3164
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Overview

Status
Completed
Phase
Phase 1
Enrollment
29 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
9 Feb 2025
Primary completion
14 May 2025
Completion
14 May 2025
First posted
11 Feb 2025
Last update posted
25 Aug 2026
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026
  1. Ph 1

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

    NCT06820476

    9 Feb 2025 to 14 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NNC0487-0111Drug
  • Placebo (NNC0487-0111)Drug

Arms4

  • Experimental

    NNC0487-0111 (dose 1)

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

  • Experimental

    NNC0487-0111 (dose 2)

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

  • Experimental

    NNC0487-0111 (dose 3)

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

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame · From first NNC0487-0111 administration (Day 1) to completion of the end-of-study visit (Day 31)

    Registry description

    Number of events

Secondary outcomes(5)

  1. AUC0-24h,MD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 24 hours after last multiple dose

    Time frame · From pre-dose on Day 10 until Day 11

    Registry description

    measured in hour\*nanomoles per liter (h\*nmol/L)

  2. Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose

    Time frame · From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)

    Registry description

    measured in nanomoles per liter(nmol/L)

  3. tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose

    Time frame · From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)

    Registry description

    measured in hour (h)

  4. Change in bodyweight

    Time frame · From baseline Day 1 to Day 11

    Registry description

    measured in percentage (%)

  5. Change in fasting plasma glucose

    Time frame · From baseline Day 1 to Day 11

    Registry description

    measured in millimoles per liter (mmol/L)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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