A Study on How NNC0174-1213 Works in People With Overweight or Obesity.
A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male Participants With Overweight or Obesity.
Novo Nordisk A/S
177 participants
Dec 3, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria16
- 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
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Interventions
Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06719011