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Clinical Trials in the Netherlands / NCT06577766
Active, not recruiting Phase 1

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

NCT06577766 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 1
Started
2024-09-03
Last updated
2026-09-30

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

NNC0638-0355Placebo (NNC0638-0355)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Key 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. Key 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

Primary outcome measure(s)

  • Part A: Number of treatment emergent adverse events (TEAE) — From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)
    Measured as Number of events
  • Part B,C,D and E : Number of treatment emergent adverse events (TEAE) — From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)
    Measured as Number of events

Trial sites (4)

FacilityCityRegionStatus
ICON Early Phase Services, LLC Lenexa Kansas
ICON San Antonio Texas
ICON-Salt Lake City Salt Lake City Utah
ICON - location Groningen Groningen Netherlands

More Novo Nordisk A/S trials in the Netherlands

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A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy People Recruiting
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight Recruiting
Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) Active, not recruiting

Other trials for the same condition

PET-study on the Role of the Reward System in Weight Loss After Bariatric Surgery Active, not recruiting
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight Recruiting
Butyrate-enriched Triglyceride and Diabetes Prevention Recruiting
A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants Active, not recruiting
Plant-based Protein-rich Weight Loss Intervention in 55+ Adults With Obesity Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06577766 on ClinicalTrials.gov ↗ ← All trials in the Netherlands