Advertising disclosure: we may earn a commission when you buy through links on this site. How we make money

HomeTrials › NCT06719011

Obesity & weight · Phase 1 · Recruiting now

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

NCT06719011 · Sponsor: Novo Nordisk A/S

What this trial means for you

This study is recruiting now at 2 US sites. It's studying NNC0174-1213 A, Cagrilintide B, Placebo A (NNC0174 1213 A) for obesity, overweight.

Who can joinMen, 18 Years – 55 Years
Healthy volunteersNo — diagnosis required
What you'd takeNNC0174-1213 A, Cagrilintide B, Placebo A (NNC0174 1213 A)
Study length~16 months overall
Planned participants177
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

Texas

  • ICON Early Phase Services, LLC — San Antonio · Recruiting now

Utah

  • ICON Early Phase Services, LLC — Salt Lake City · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

Follow this trial

Get an email when our monthly digest covers enrollment changes and results for trials like this one.

Newsletter signup launches soon. (Site owner: set PUBLIC_BUTTONDOWN_USERNAME in .env to activate this form.)

Keep researching on StudyBackedHealth