A Study on How NNC0174-1213 Works in People With Overweight or Obesity.

Launched by NOVO NORDISK A/S · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called NNC0174-1213 to help people who are overweight or obese. The main goal is to find out if this medication is safe and how it works in the human body. Participants will be randomly assigned to receive either the new medication, another study medicine called "cagrilintide," or a placebo, which is a harmless dummy treatment that doesn’t contain any active ingredients. The study will last for about a year, and during this time, researchers will monitor how participants respond to the treatments.

To be eligible for this study, participants must be males aged 18 to 55 years with a body mass index (BMI) between 27 and 34.9, which means they are considered overweight. They also need to weigh at least 80 kilograms. However, there are some health conditions that might exclude someone from participating, such as liver or kidney problems, or if they have taken similar medications recently. Those who join the study can expect regular check-ups to ensure their safety and to see how well the medication works. This is an important step in developing potential new treatments for obesity.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male.
• • 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