A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing
NCT ID: NCT06820476
Last Updated: 2025-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2025-02-09
2025-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NNC0487-0111 (dose 1)
Participants will be randomized to receive a single dose of NNC0487-0111.
NNC0487-0111
Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.
NNC0487-0111 (dose 2)
Participants will be randomized to receive a single dose of NNC0487-0111.
NNC0487-0111
Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.
NNC0487-0111 (dose 3)
Participants will be randomized to receive a single dose of NNC0487-0111.
NNC0487-0111
Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.
Placebo
Participants will be randomized to receive matching Placebo to NNC0487-0111.
Placebo (NNC0487-0111)
Participants will be randomized to receive a placebo tablet orally matched to NNC0487-0111.
Interventions
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NNC0487-0111
Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.
Placebo (NNC0487-0111)
Participants will be randomized to receive a placebo tablet orally matched to NNC0487-0111.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
MALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Jinan Central Hospital Affiliated to Shandong University
Ji'Nan, Shandong, China
Jinan Central Hospital
Ji'Nan, Shandong, China
Countries
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Other Identifiers
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U1111-1289-3164
Identifier Type: OTHER
Identifier Source: secondary_id
NN9487-7573
Identifier Type: -
Identifier Source: org_study_id
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