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OpenTrials
Completed

NCT Number: NCT06064006

A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female
  • Aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • 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

  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening
  • Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
  • Vitamin D (25-hydroxycholecalciferol) below 12 ng/mL (30 nM) at screening
  • Parathyroid hormone (PTH) outside normal range at screening
  • Total calcium outside normal range at screening
  • Amylase equal to or greater than 2 times upper limit of normal at screening
  • Lipase equal to or greater than 2 times upper limit of normal at screening
  • Calcitonin equal to or greater than 50 ng/L at screening

Treatment and study plan

NNC0487-0111

Drug

NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.

Placebo (NNC0487-0111)

Drug

Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.

Primary outcomes

  1. PART A: Number of treatment emergent adverse events (TEAE)

    Time frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25

    Number of events

  2. PARTS B to E: Number of treatment emergent adverse events (TEAE)

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270

    Number of events

Secondary outcomes

  1. PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25

    h*nmol/L

  2. PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax

    Time frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25

    nmol/L

  3. PARTS B to E: AUC0-168h,SS; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 168 hours after last multiple dose

    Time frame: From pre-dose on V33D1 until end of treatment (V34) up to 9 days

    h*nmol/L

  4. PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax

    Time frame: From pre-dose on V33D1 until end of study visit (V37) up to 24 days

    nmol/L

  5. PART B to E: Relative change in body weight

    Time frame: From pre-dose on Day 1 until end of treatment (V34) up to Day 255

    Percentage (%)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Placebo-controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0487-0111 in Participants With Overweight or Obesity

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2023
Registry last updated
Nov 19, 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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