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Completed

NCT Number: NCT06820476

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Jinan Central Hospital, Ji'Nan, Shandong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC0487-0111

Drug

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

Placebo (NNC0487-0111)

Drug

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

Primary outcomes

  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)

    Number of events

Secondary outcomes

  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

    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)

    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)

    measured in hour (h)

  4. Change in bodyweight

    Time frame: From baseline Day 1 to Day 11

    measured in percentage (%)

  5. Change in fasting plasma glucose

    Time frame: From baseline Day 1 to Day 11

    measured in millimoles per liter (mmol/L)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Oral Doses of NNC0487-0111 in Chinese Participants With Overweight or Obesity

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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