NCT06577766Active, not recruitingPhase 1
A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 28 Aug 2024
- Start date
- 3 Sept 2024
- Primary completion date
- 11 Oct 2027
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT06577766
- EU CT number
- 2026-526797-16-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 63
- From 3 Sept 2024 to the primary completion date, 11 Oct 2027
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pharmaceutical Research Associates Group B.V. Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| ICON Early Phase Services, LLC Coordinator of this site? Confirm its status | Lenexa | United States | Unknown status |
| ICON-Salt Lake City Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| ICON Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.