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A Study on NNC0174-1213 for Overweight or Obesity

This study is investigating NNC0174-1213, a potential new medicine for people who are overweight or have obesity. Researchers want to understand if NNC0174-1213 is safe, how it works in the body, and what the body does to the medicine. You would receive either NNC0174-1213, another study medicine called Cagrilintide, or a placebo (an inactive substance). Which treatment you receive is decided by chance. The main goal is to track any side effects (adverse events) that occur. This study is looking for men aged 18-55 years with a BMI between 27.0 and 34.9 and a body weight of at least 80 kg. The study's status is currently unclear, and it aims to enroll 177 participants.

Study design
This is an interventional study where participants are randomly assigned to receive one of the study treatments. It will involve different doses of the medicines.
What's involved
Participants will receive injections under the skin. The study will last for about a year in total.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects from the first administration (Day 1) until the end of study visit (Day 46 for Part A, Day 67 for Part B).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06719011

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

Completed
PHASE1Ages 18–55InterventionalTreatment
Novo Nordisk A/S
~178 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:NNC0174-1213 ACagrilintide BPlacebo A (NNC0174 1213 A)

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213
Measured over From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)
+1 more outcome measured

Conditions

Obesity
Overweight

Explore related trials

ObesityOverweight

Where it's being run

2 sites across 2 states
Texas1
Utah1

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)

    Number of events

  • Part B: Number of treatment emergent adverse events (TEAE)From first administration (Day 1) to completion of the end of study visit (Day 67)

    Number of events