Clinical trial NCT06820476: A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing
Official title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Oral Doses of NNC0487-0111 in Chinese Participants With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From first NNC0487-0111 administration (Day 1) to completion of the end-of-study visit (Day 31)
Secondary outcomes:
measure: AUC0-24h,MD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 24 hours after last multiple dose
timeFrame: From pre-dose on Day 10 until Day 11
measure: Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose
timeFrame: From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)
measure: tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose
timeFrame: From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)
measure: Change in bodyweight
timeFrame: From baseline Day 1 to Day 11
measure: Change in fasting plasma glucose
timeFrame: From baseline Day 1 to Day 11
Other outcomes:
Locations:
city: Ji'Nan
country: China
facility: Jinan Central Hospital
state: Shandong
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: