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

NCT07101783 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9662-8159U1111-1315-2937
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• AUC; The area under the NNC0662-0419 plasma concentration-time curve

  Measured in hours\*nanomoles per liter (h\*nmol/L).

  From pre-dose on Day 1 until completion of the end of study visit (Day 29)

Secondary Outcomes (2)

• Cmax; The maximum plasma concentration of NNC0662-0419

  From pre-dose on Day 1 until completion of the end of study visit (Day 29)

• Number of treatment-emergent adverse events (TEAEs)

  From time of dosing on Day 1 until completion of the end of study visit (Day 29)

Study Arms (3)

NNC0662-0419 (Dose 1)

EXPERIMENTAL

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

Drug: NNC0662-0419

NNC0662-0419 (Dose 2)

EXPERIMENTAL

Participants will receive a SD of NNC0662-0419 subcutaneously.

Drug: NNC0662-0419

NNC0662-0419 (Dose 3)

EXPERIMENTAL

Participants will receive a SD of NNC0662-0419 subcutaneously.

Drug: NNC0662-0419

Interventions

NNC0662-0419 DRUG

Participants will receive NNC0662-0419 subcutaneously.

NNC0662-0419 (Dose 1); NNC0662-0419 (Dose 2); NNC0662-0419 (Dose 3)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• nd 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)