Actively Recruiting

Phase 1
Age: 18Years - 55Years
MALE
NCT06719011

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

Led by Novo Nordisk A/S · Updated on 2025-05-25

177

Participants Needed

2

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male
  • Age 18 to 55 years inclusive at the time of signing informed consent
  • Body mass index (BMI) between 27.0 and 34.9 kg/m² inclusive at screening
  • Body weight of at least 80.0 kilograms at screening
  • Eligible based on medical history, physical exam, vital signs, ECG, and lab tests as judged by the investigator
Not Eligible

You will not qualify if you...

  • Known or suspected allergy to study medicines or related products
  • Use of investigational medicines within 2 months or 5 half-lives before screening
  • Previous use of amylin or calcitonin receptor agonist medicines within 6 months
  • Impaired liver function: AST or ALT ≥ 2 times upper limit of normal, or bilirubin > 1.5 times upper limit (unless Gilbert's syndrome)
  • Kidney function with eGFR less than 75 mL/min/1.73 m² at screening
  • HbA1c of 6.5% or higher at screening
  • Significant body weight change (≥ 5%) or dieting attempts within 90 days before screening
  • Any condition or inability that may affect safety or study compliance
  • Abnormal lab values at screening for vitamin D (< 12 ng/mL), parathyroid hormone outside normal range, total calcium outside normal range, or calcitonin ≥ 50 ng/L

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

ICON Early Phase Services, LLC

San Antonio, Texas, United States, 78209

Actively Recruiting

2

ICON Early Phase Services, LLC

Salt Lake City, Utah, United States, 84124

Actively Recruiting

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Research Team

N

Novo Nordisk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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