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NCT Number: NCT07121153

A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants When Injected Under the Skin.

The study is testing a new medicine (NNC0487-0111) for weight control in Chinese people with BMI between 24 kilogram per meter square (kg/m2) and 34.9 kg/m2. The aim of the study is to see how safe the study medicine is and how it behaves in human body. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) and which treatment they get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors but has previously been tested in humans. This study will last for up to 53 days.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Jinan Central Hospital

Jinan, Shandong, 250000, China

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 between 24.0 and 34.9 kg/m2 (both inclusive) at screening. Overweight and obesity should be due to excess adipose tissue, as judged by the investigator, with a body weight (more than or equal to) ≥ 65.0 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 condition, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • HbA1c ≥ 6.5 percent (%) [48 milimol per mole (mmol/mol)] at screening.
  • Any laboratory safety parameters at screening outside the below laboratory ranges:
  • Vitamin D (25-hydroxycholecalciferol) less than (<) 12 nanogram per mililiter (ng/mL) [30 nanometer (nM)] at screening
  • Parathyroid hormone (PTH) outside normal range at screening
  • Total calcium outside normal range at screening
  • Amylase ≥ 2 times upper limit of normal at screening
  • Lipase ≥ 2 times upper limit of normal at screening
  • Calcitonin ≥ 50 picogram per mililiter (pg/mL) at screening

Treatment and study plan

NNC0487-0111 A

Drug

Participants will receive single dose (level 1, level 2, level 3) injection of NNC0487-0111 A subcutaneoulsy.

Placebo A

Drug

Participants will receive single dose (level 1, level 2, level 3) injection of placebo A subcutaneoulsy.

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From NNC0487-0111 administration (Day 1) to completion of the end of study visit (Day 23)

    Number of events

Secondary outcomes

  1. AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 23)

    h*nmol/L

  2. Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 23)

    nmol/L

  3. tmax,SD; the time of maximum plasma concentration of NNC0487-0111 after a single dose

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 23)

    h

  4. t1/2,SD; the terminal half-life of NNC0487-0111 after a single dose

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 23)

    h

  5. Relative change in body weight

    Time frame: From baseline Day 1 until completion of the end of study visit (Day 23)

  6. Change in fasting plasma glucose

    Time frame: From baseline Day 1 until completion of the end of study visit (Day 23)

    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 Single Doses of Subcutaneous NNC0487-0111 in Chinese Participants With Overweight or Obesity.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Feb 17, 2026

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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