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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT06064006 (opens ClinicalTrials.gov in a new tab)Other idNN9490-7613Other idU1111-1289-3282
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
125 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
15 Sept 2023
Primary completion
27 Nov 2024
Completion
27 Nov 2024
First posted
3 Oct 2023
Last update posted
19 Nov 2025
Conditions
Obesity · Overweight

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 2

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

    NCT06064006

    15 Sept 2023 to 27 Nov 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • NNC0487-0111Drug
  • Placebo (NNC0487-0111)Drug

Arms2

  • Experimental

    NNC0487-0111

    Participants will be randomized to receive NNC0487-0111. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD)

  • Placebo comparator

    Placebo

    Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B,C,D and E: Multiple ascending dose (MAD).

Primary outcomes2

Outcomes the sponsor listed as primary.

  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

    Registry description

    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

    Registry description

    Number of events

Secondary outcomes(5)

  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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Percentage (%)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

4 results

Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study.

Dahl et al. 2025Lancet (London, England)cited by 59

PMID 40550231DOI 10.1016/s0140-6736(25)01185-7PUB-40550231

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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