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A Research Study on How a Dose of NNC0662-0419 Works in Japanese, Chinese and Non-Asian Participants Living With Overweight or Obesity

NCT ID: NCT07101783

Last Updated: 2025-12-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-10-31

Brief Summary

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The study is testing the new medicine NNC0662-0419 in people living with overweight or obesity. The purpose of the study is to look into the amount of the new medicine NNC0662-0419 in participants blood after one dose. And also look into how safe and how well the study medicine is tolerated in people living with overweight or obesity. NNC0662-0419 is a new medicine which cannot be prescribed by doctors. NNC0662-0419 is currently being tested in humans and the dose participants will receive has been found safe and tolerable. Participants will get a single dose of NNC0662-0419 given by study staff as a single injection under participants skin. Like all medicines, the study medicine may have side effects. The study will last up to 2 months.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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NNC0662-0419 (Dose 1)

Participants will receive a single dose (SD) of NNC0662-0419 subcutaneously.

Group Type EXPERIMENTAL

NNC0662-0419

Intervention Type DRUG

Participants will receive NNC0662-0419 subcutaneously.

NNC0662-0419 (Dose 2)

Participants will receive a SD of NNC0662-0419 subcutaneously.

Group Type EXPERIMENTAL

NNC0662-0419

Intervention Type DRUG

Participants will receive NNC0662-0419 subcutaneously.

NNC0662-0419 (Dose 3)

Participants will receive a SD of NNC0662-0419 subcutaneously.

Group Type EXPERIMENTAL

NNC0662-0419

Intervention Type DRUG

Participants will receive NNC0662-0419 subcutaneously.

Interventions

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NNC0662-0419

Participants will receive NNC0662-0419 subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female (sex at birth) Japanese, Chinese or non-Asian participants (all self-reported).

* For Japanese participants: both parents of Japanese descent.
* For Chinese participants: both parents of Chinese descent.
* For non-Asian participants: both parents of non-Asian descent (non-Asian is defined as of countries outside of Asia).
* 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) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* 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

* Known a\* or suspected hypersensitivity to study intervention(s) or related products.
* Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
* 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 millisecond (msec), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 msec (females) or 430 msec (males), or any other clinically significant abnormal electrocardiogram (ECG) results as judged by the investigator, at screening.
* Glycated haemoglobin (HbA1c) greater than or equal to \>= 6.5percent (%) (48 millimoles per liter \[mmol/mol\]) at screening.
* Calcitonin \>= 50 nanogram per liter (ng/L) at screening. a\* - As declared by the participant or reported in the medical records.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Altasciences Clinical LA, Inc.

Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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U1111-1315-2937

Identifier Type: OTHER

Identifier Source: secondary_id

NN9662-8159

Identifier Type: -

Identifier Source: org_study_id