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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: NNC0487-0111; Drug: Placebo (NNC0487-0111)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Ji'Nan, Shandong, China, 250000
      • Jinan Central Hospital
    • Ji'Nan, Shandong, China, 250000
      • Jinan Central Hospital Affiliated to Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0487-0111 (dose 1); Participants will be randomized to receive a single dose of NNC0487-0111.	Drug: NNC0487-0111; Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.
Experimental: NNC0487-0111 (dose 2); Participants will be randomized to receive a single dose of NNC0487-0111.	Drug: NNC0487-0111; Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.
Experimental: NNC0487-0111 (dose 3); Participants will be randomized to receive a single dose of NNC0487-0111.	Drug: NNC0487-0111; Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.
Placebo Comparator: Placebo; Participants will be randomized to receive matching Placebo to NNC0487-0111.	Drug: Placebo (NNC0487-0111); Participants will be randomized to receive a placebo tablet orally matched to NNC0487-0111.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAEs)	Number of events	From first NNC0487-0111 administration (Day 1) to completion of the end-of-study visit (Day 31)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-24h,MD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 24 hours after last multiple dose	measured in hour*nanomoles per liter (h*nmol/L)	From pre-dose on Day 10 until Day 11
Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose	measured in nanomoles per liter(nmol/L)	From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)
tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose	measured in hour (h)	From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)
Change in bodyweight	measured in percentage (%)	From baseline Day 1 to Day 11
Change in fasting plasma glucose	measured in millimoles per liter (mmol/L)	From baseline Day 1 to Day 11

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2025
• Primary Completion (Actual): May 14, 2025
• Study Completion (Actual): May 14, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: NN9487-7573; U1111-1289-3164 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No