Current partner codePEPTIDESDE
NCT06820476·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

29

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

NNC0487-0111

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

DRUG

Placebo (NNC0487-0111)

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

Timeline

From registration to results.

  1. First posted

    Feb 11, 2025

  2. Study start

    Feb 9, 2025

  3. Primary completion

    May 14, 2025

  4. Study completion

    May 14, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Aug 20, 2025

Outcomes

What the study measures.

Primary outcomes

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

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)

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)

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)

Change in bodyweight

Time frame · From baseline Day 1 to Day 11

measured in percentage (%)

Change in fasting plasma glucose

Time frame · From baseline Day 1 to Day 11

measured in millimoles per liter (mmol/L)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
MALE
Healthy volunteers
No

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 locations

2 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Jinan Central Hospital Affiliated to Shandong University

Ji'Nan, Shandong, China

Jinan Central Hospital

Ji'Nan, Shandong, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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