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Trial · Interventional

RecruitingPhase 3Registry data

AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight

Short name AMAZE 1

NCTNCT07339423 (opens ClinicalTrials.gov in a new tab)Other idNN9490-8021Other idU1111-1313-6262Other id2024-520440-42
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
1,150 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
9 countries

United States, Argentina, Australia, Belgium, Canada, Denmark, France, Germany, United Kingdom

Start
24 Feb 2026
Primary completion
26 Jun 2029 (estimated)
Completion
21 Aug 2029 (estimated)
First posted
14 Jan 2026
Last update posted
24 Sept 2026
Conditions
Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262027202820292030
  1. Ph 3

    AMAZE 1

    NCT07339423

    24 Feb 2026 to est. 21 Aug 2029

Registry summary

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

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Interventions

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

Arms2

  • Experimental

    NNC0487-0111

    Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

  • Placebo comparator

    Placebo

    Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative change in body weight

    Time frame · From baseline (week 0) to week 84

    Registry description

    Measured as percentage of body weight.

Secondary outcomes(20)

  1. Change in waist circumference

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as centimetre (cm).

  2. Change in systolic blood pressure (SBP)

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as millimetre of mercury (mmHg).

  3. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.

  4. Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6.

  5. Change in body weight

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as kilogram (kg).

  6. Change in body mass index (BMI)

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as kilograms per meter squared (kg/m\^2).

  7. Change in IWQOL-Lite-CT physical composite score

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical composite score ranges from 0-100.

  8. Change in IWQOL-Lite-CT psychosocial composite score

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The psychosocial composite score ranges from 0-100.

  9. Change in IWQOL-Lite-CT total score

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.

  10. Change in glycated haemoglobin (HbA1c)

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as percentage of HbA1c.

  11. Change in fasting plasma glucose (FPG)

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as millimole per liter (mmol/L).

  12. Ratio to baseline: change in fasting insulin

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as ratio.

  13. Change in diastolic blood pressure (DBP)

    Time frame · From baseline (week 0) to week 84

    Registry description

    Measured as mmHg.

  14. Ratio to baseline: change in total cholesterol

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as ratio.

  15. Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as ratio.

  16. Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as ratio.

  17. Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as ratio.

  18. Ratio to baseline: change in non-HDL cholesterol

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as ratio.

  19. Ratio to baseline: change in triglycerides

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as ratio.

  20. Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)

    Time frame · From baseline (week 0) to week 84 and week 136

    Registry description

    Measured as ratio.

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.

A trial that is still running, or that stopped early, may post results later.

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Key Inclusion Criteria: * Male or female (sex at birth). * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * History of at least one self-reported unsuccessful dietary effort to lose body weight. Key Exclusion Criteria: * HbA1c ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records. * Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.

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