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

NCT06820476 | Completed Phase 1

• 2 other identifiers: NN9487-7573U1111-1289-3164
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  From pre-dose on Day 10 until Day 11

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

  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

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

• Change in bodyweight

  From baseline Day 1 to Day 11

• Change in fasting plasma glucose

  From baseline Day 1 to Day 11

Study Arms (4)

NNC0487-0111 (dose 1)

EXPERIMENTAL

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

Drug: NNC0487-0111

NNC0487-0111 (dose 2)

EXPERIMENTAL

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

Drug: NNC0487-0111

NNC0487-0111 (dose 3)

EXPERIMENTAL

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

Drug: NNC0487-0111

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (NNC0487-0111)

Interventions

NNC0487-0111 DRUG

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

NNC0487-0111 (dose 1); NNC0487-0111 (dose 2); NNC0487-0111 (dose 3)

Placebo (NNC0487-0111) DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Jinan Central Hospital Affiliated to Shandong University

Ji'Nan, Shandong, 250000, China

Location

Jinan Central Hospital

Ji'Nan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: February 9, 2025
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)