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Trial · Interventional

CompletedPhase 1Registry data

A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity

NCTNCT05369390 (opens ClinicalTrials.gov in a new tab)Other idNN9487-4830Other idU1111-1270-0852
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
11 May 2022
Primary completion
9 Jan 2024
Completion
9 Jan 2024
First posted
11 May 2022
Last update posted
15 Jun 2025
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 1

    A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity

    NCT05369390

    11 May 2022 to 9 Jan 2024

Registry summary

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

NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel full. This study tests if the study medicine is safe and to find out how the medicine works in humans. This study also look at how the study medicine affects body weight and how to improve the treatment of people with overweight, obesity or related diseases. This study will have 4 parts: Part A, B, C and D. Part A: This is planned to consist of five groups, one additional group may be added. Each group will include 8 participants, with 6 participants being randomised to receive a single dose of NNC0487-0111 A and 2 participants randomised to receive placebo. The dosing within each group will be sequential, i.e., 2 sentinel participants (1 on active and 1 on placebo). Part B: This is planned to consist of three groups, one additional group may be added. Each group will include 12 participants, with 9 participants being randomised to receive NNC0487-0111 A and 3 participants randomised to receive placebo once daily for 10 days. The dosing within each group will be sequential. For the first group, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of 7 days (168 hours), before dosing of the remaining participants in the group will be initiated. For the remaining groups, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the group will be initiated. Part C and D are matching regarding planned visits and procedures, but the study interventions in Part D (NNC0487-0111 B) differ from Part A, B and C (NNC0487-0111 A). Each part is planned to consist of one group, although one additional group may be added. Each group will include 20 participants, with 16 participants being randomised to receive active treatment and 4 participants randomised to receive placebo once-daily for 12 weeks. The dosing will be sequential, i.e., 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the cohort will be initiated. The remaining participants will be dosed in smaller groups of 8 participants separated by a safety observation period of at least 36 hours. A safety evaluation will be made between dosing of participants within a group and before moving on to a higher dose.

Interventions

  • NNC0487-0111 ADrug
  • NNC0487-0111 BDrug
  • Placebo B (NNC0487-0111 B)Other
  • Placebo A (NNC0487-0111 A)Other

Arms4

  • Experimental

    Part A: Single ascending dose (SAD)

    Participants will receive a single dose of any of the six different dose levels (1, 3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts.

  • Experimental

    Part B: Multiple ascending dose (MAD)

    Participants will receive NNC0487-0111 once daily for 10 days at any of the five different dose levels (3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts.

  • Experimental

    Part C

    Participants will receive NNC0487-0111 A or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12.

  • Experimental

    Part D

    Participants will receive NNC0487-0111 B or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of treatment emergent adverse events (TEAE)

    Time frame · Part A: From pre-dose on Day 1 to 22 days; Part B: From pre-dose on Day 1 to 31 days; Part C and D: From pre-dose on Day 1 to 105 days

    Registry description

    Number of events

Secondary outcomes(6)

  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 (Day 22)

    Registry description

    Hours\*Nanomoles per liter (h\*nmol/L)

  2. Part A: Cmax,SD; the maximum plasma concentration of NNC0487- 0111 after a single dose

    Time frame · From pre-dose on Day 1 until completion of the end of study visit (Day 22)

    Registry description

    Nanomoles per liter (nmol/L)

  3. Part B: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose

    Time frame · From pre-dose on Day 10 until Day 11 (24 hours post-dose)

    Registry description

    h\*nmol/L

  4. Part B: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose

    Time frame · From pre-dose on Day 10 until Day 22

    Registry description

    nmol/L

  5. Part C and D: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose

    Time frame · From pre-dose on Day 84 until Day 85 (24 hours post-dose)

    Registry description

    h\*nmol/L

  6. Part C and D: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose

    Time frame · From pre-dose on Day 84 until completion of the end of study visit (Day 105)

    Registry description

    nmol/L

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

2 results

Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial.

Gasiorek et al. 2025Lancet (London, England)cited by 33

PMID 40550229DOI 10.1016/s0140-6736(25)01176-6PUB-40550229

Full text at the publisher2 results
Publisher pageSee results (2)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Part A and B: * Male or female aged 18-55 years (both inclusive) at time of signing informed consent * Body mass index (BMI) of 25.0 to 34.9 kilogram per square meter (kg/m\^2) (both inclusive) 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. Part C and D: * Male or female aged 18-55 years (both inclusive) at time of signing informed consent * Body mass index (BMI) of 27.0 to 39.9 kg/m\^2 (both inclusive) 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: Part A and B: * Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * HbA1c greater than or equal to 6.5 % (48 millimoles per mole (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) less than 20 Nanograms per milliliter (ng/mL) (50 nano molar (NM)) at screening * Parathyroid hormone (PTH) outside normal range at screening * Total calcium outside normal range at screening * Amylase greater than or equal to 2 times upper limit of normal at screening * Lipase greater than or equal to 2 times upper limit of normal at screening Part C and D: * Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * HbA1c greater than or equal to 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) less than 20 ng/mL (50 nM) at screening * Parathyroid hormone (PTH) outside normal range at screening * Total calcium outside normal range at screening * Amylase greater than or equal to 2 times upper limit of normal at screening * Lipase greater than or equal to 2 times upper limit of normal at screening

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