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NCT Number: NCT06719011

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, LLC, San Antonio, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC0174-1213 A

Drug

Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection.

Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

Cagrilintide B

Drug

Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection.

Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

Placebo A (NNC0174 1213 A)

Drug

Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection.

Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

Primary outcomes

  1. Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213

    Time frame: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)

    Number of events

  2. Part B: Number of treatment emergent adverse events (TEAE)

    Time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)

    Number of events

Secondary outcomes

  1. Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve

    Time frame: From pre-dose on Day 1 to completion of the end of study visit (Day 46)

    measured in hour*nanomoles per liter (h*nmol/L).

  2. Part A: Cmax; maximum observed NNC0174 1213 plasma concentration

    Time frame: From pre-dose on Day 1 to completion of the end of study visit (Day 46)

    measured in nanomoles per liter (nmol/L).

  3. Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve

    Time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)

    measured in h*nmol/L.

  4. Part B: Cmax; maximum observed NNC0174 1213 plasma concentration

    Time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)

    measured in nmol/L.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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