Testing a new medicine for overweight and 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.
This study is testing a new medicine for overweight and obesity to see if it helps people lose weight and improve their health compared to other treatments or a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 177 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Male |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 2 sites (San Antonio, Texas and 1 other locations) |
| Trial ID | NCT06719011 on ClinicalTrials.gov |
What this trial studies
This study is evaluating the safety and effectiveness of a new medication, NNC0174-1213, in individuals with overweight or obesity. Participants will be randomly assigned to receive either the new medication, another study medication called cagrilintide, or a placebo. The study aims to understand how the medication works in the human body and how the body responds to it. The total duration of the study is approximately one year.
Who should consider this trial
Good fit: Ideal candidates are males aged 18-55 with a BMI between 27.0 and 34.9 kg/m² and a body weight of at least 80 kg.
Not a fit: Patients with known hypersensitivity to the study medications or those who have recently received similar treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals struggling with overweight and obesity.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific medication is novel and untested in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Antonio, Texas and 1 other locations
- ICON Early Phase Services, LLC — San Antonio, Texas, United States (Recruiting)
- ICON Early Phase Services, LLC — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.