RECRUITING

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

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Conditions

ObesityOverweight

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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.

Quick Facts

Study Start:2024-12-03
Study Completion:2026-03-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06719011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male.
  2. * Age 18-55 years (both inclusive) at the time of signing the informed consent.
  3. * 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.
  4. * Body weight more than or equal to (\>=) 80.0 kilograms (kg) at screening.
  5. * 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.
  1. * Known or suspected hypersensitivity to study intervention(s) or related products.
  2. * 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.
  3. * Participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months.
  4. * Impaired liver function defined as any of the below:
  5. * Aspartate aminotransferase (AST) more than or equal to (\>=) 2 times upper limit of normal at screening
  6. * Alanine aminotransferase (ALT) more than or equal to (\>=) 2 times upper limit of normal at screening
  7. * Bilirubin more than (\>) 1.5 times upper limit of normal at screening (except if known or proven Gilbert's syndrome)
  8. * 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.
  9. * Glycated haemoglobin (HbA1c) more than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole (mmol/mol) at screening.
  10. * 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 .
  11. * Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
  12. * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
  13. * Vitamin D (25-hydroxycholecalciferol) less than (\<) 12 nanogram per milliliter (ng/mL) (30 nanometer (nM) at screening
  14. * Parathyroid hormone (PTH) outside normal range at screening
  15. * Total calcium outside normal range at screening
  16. * Calcitonin more than or equal to (\>=) 50 nanogram per liter (ng/L) at screening

Contacts and Locations

Study Contact

Novo Nordisk
CONTACT
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Principal Investigator

Clinical Transparency (dept. 2834)
STUDY_DIRECTOR
Novo Nordisk A/S

Study Locations (Sites)

ICON Early Phase Services, LLC
San Antonio, Texas, 78209
United States
ICON Early Phase Services, LLC
Salt Lake City, Utah, 84124
United States

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

  • Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-03
Study Completion Date2026-03-26

Study Record Updates

Study Start Date2024-12-03
Study Completion Date2026-03-26

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Overweight