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OpenTrials
Active, not recruiting

NCT Number: NCT06577766

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON - location Groningen, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

NNC0638-0355

Drug

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

Placebo (NNC0638-0355)

Drug

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

Primary outcomes

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

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

    Measured as Number of events

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

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

    Measured as Number of events

Secondary outcomes

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

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

    Measured in hours*nano mole per litre (h*nmol/L)

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

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

    Measured in nano mole per litre (nmol/L)

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

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

    Measured in hour*nano mole per litre (h*nmol/L)

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

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

    Measured in nano mole per litre (nmol/L)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Placebo Controlled, Double Blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Doses of NNC0638-0355 in Participants With Overweight or Obesity

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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