A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity

NCT ID: NCT06577766

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-03
• Study Completion Date: 2026-09-24

Brief Summary

The study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NNC0638-0355

Participants will be randomized to receive NNC0638-0355. The study will be conducted in 4 parts. Part A: Single ascending dose (SAD) Part B, C and D: Multiple ascending dose (MAD).

Group Type: EXPERIMENTAL

NNC0638-0355

Intervention Type: DRUG

NNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection.

Placebo

Participants will be randomized to receive Placebo. The study will be conducted in 4 parts. Part A: Single ascending dose (SAD). Part B,C and D: Multiple ascending dose (MAD).

Group Type: PLACEBO_COMPARATOR

Placebo (NNC0638-0355)

Intervention Type: DRUG

Placebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection.

Interventions

NNC0638-0355

NNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection.

Intervention Type: DRUG

Placebo (NNC0638-0355)

Placebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female.
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• BMI between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Considered to be generally healthy 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 or suspected hypersensitivity to study intervention(s) or related products.
• Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening.
• Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:

1. Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening

2. Parathyroid hormone (PTH) outside normal range at screening

3. Total calcium outside normal range at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

ICON

San Antonio, Texas, United States

Countries

United States

Other Identifiers

NN9638-7569

Identifier Type: -

Identifier Source: org_study_id

U1111-1296-8015

Identifier Type: OTHER

Identifier Source: secondary_id