NCT06719011 A Study on How NNC0174-1213 Works in People With Overweight or Obesity.
| NCT ID | NCT06719011 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novo Nordisk A/S |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 177 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2026-03-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 177 participants in total. It began in 2024-12-03 with a primary completion date of 2026-03-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Clinical Transparency (dept. 2834)
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT06719011 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 55 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06719011 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06719011 currently recruiting?
Yes, NCT06719011 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT06719011 trial being conducted?
This trial is being conducted at San Antonio, United States, Salt Lake City, United States.
Who is sponsoring the NCT06719011 clinical trial?
NCT06719011 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency (dept. 2834) at Novo Nordisk A/S. The trial plans to enroll 177 participants.
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