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

NCT06577766 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN9638-7569U1111-1296-8015
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Part A: Number of treatment emergent adverse events (TEAE)

  Measured as Number of events

  From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)

• Part B,C,D and E : Number of treatment emergent adverse events (TEAE)

  Measured as Number of events

  From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)

Secondary Outcomes (4)

• Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve

  From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)

• Part A: Cmax; maximum observed NNC0638-0355 plasma concentration

  From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)

• Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve

  From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)

• Part B,C,D and E: Cmax; maximum observed NNC0638-0355 plasma concentration

  From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)

Study Arms (2)

NNC0638-0355

EXPERIMENTAL

Participants will be randomized to receive NNC0638-0355. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD).

Drug: NNC0638-0355

Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B, C,D and E: Multiple ascending dose (MAD).

Drug: Placebo (NNC0638-0355)

Interventions

NNC0638-0355 DRUG

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

NNC0638-0355

Placebo (NNC0638-0355) DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening
• Parathyroid hormone (PTH) outside normal range at screening
• Total calcium outside normal range at screening

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

ICON

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 29, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)