NCT06719011 · Novo Nordisk A/S
A Study on How NNC0174-1213 Works in People With Overweight or Obesity.
What this study is about
This 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 human body, and what human body does to the study medicine.
View original scientific description
This 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 human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Body weight more than or equal to (\>=) 80.0 kilograms (kg) at screening.
- Considered eligible 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.
- Exposure to an investigational medicinal product within 2 months or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- Participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months.
- Impaired liver function defined as any of the below:
- Aspartate aminotransferase (AST) more than or equal to (\>=) 2 times upper limit of normal at screening
- Alanine aminotransferase (ALT) more than or equal to (\>=) 2 times upper limit of normal at screening
- Bilirubin more than (\>) 1.5 times upper limit of normal at screening (except if known or proven Gilbert's syndrome)
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 75 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) at screening.
- Glycated haemoglobin (HbA1c) more than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole (mmol/mol) at screening.
- Any clinically significant body weight change more than or equal to (\>=) 5 percent (%) self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening .
- Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
- 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 nanogram per milliliter (ng/mL) (30 nanometer (nM) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
- Calcitonin more than or equal to (\>=) 50 nanogram per liter (ng/L) at screening
Where
- San Antonio, Texas
- Salt Lake City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 25, 2025 · Source of record for eligibility and locations