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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: NNC0662-0419

Study type: Interventional

Funder types: Industry

Identifiers

NCT07101783

U1111-1315-2937 (Other Identifier)

NN9662-8159

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups

NNC0662-0419 (Dose 1)

Experimental group

Description:

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

Treatment:

Drug: NNC0662-0419

NNC0662-0419 (Dose 2)

Experimental group

Description:

Participants will receive a SD of NNC0662-0419 subcutaneously.

Treatment:

Drug: NNC0662-0419

NNC0662-0419 (Dose 3)

Experimental group

Description:

Participants will receive a SD of NNC0662-0419 subcutaneously.

Treatment:

Drug: NNC0662-0419