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NCT Number: NCT07503210

AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Conexa, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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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 or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.

Exclusion criteria

  • Glycated haemoglobin (HbA1c) greater than or equal to ≥ 6.5% [48 millimoles 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.

Treatment and study plan

NNC0487-0111

Drug

NNC0487-0111 will be administered subcutaneously.

Placebo (matched to NNC0487-0111)

Drug

Placebo will be administered subcutaneously.

Primary outcomes

  1. Relative change in body weight

    Time frame: From week 40 to week 92

    Measured as percentage (%) of body weight.

Secondary outcomes

  1. Relative change in body weight

    Time frame: From week 0 to week 92

    Measured as % of body weight.

  2. Change in waist circumference

    Time frame: From week 40 to week 92

    Measured as centimetre (cm).

  3. Change in systolic blood pressure (SBP)

    Time frame: From week 40 to week 92

    Measured as millimeter of mercury (mmHg).

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

    Time frame: From week 40 to week 92

    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.

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

    Time frame: From week 40 to week 92

    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.

  6. Change in body weight

    Time frame: From week 40 to week 92

    Measured as kilogram (kg).

  7. Change in body mass index (BMI)

    Time frame: From week 40 to week 92

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

  8. Change in body weight

    Time frame: From week 0 to week 92

    Measured as kg.

  9. Change in BMI

    Time frame: From week 0 to week 92

    Measured as kg/m^2.

  10. Change in glycated haemoglobin (HbA1c)

    Time frame: From week 40 to week 92

    Measured as % of HbA1c.

  11. Change in fasting plasma glucose (FPG)

    Time frame: From week 40 to week 92

    Measured as millimoles per liter (mmol/L).

  12. Change in fasting insulin

    Time frame: From week 40 to week 92

    Measured as ratio to baseline.

  13. Change in diastolic blood pressure (DBP)

    Time frame: From week 40 to week 92

    Measured as mmHg.

  14. Change in total cholesterol

    Time frame: From week 40 to week 92

    Measured as ratio to baseline.

  15. Change in High-density lipoprotein (HDL) cholesterol

    Time frame: From week 40 to week 92

    Measured as ratio to baseline.

  16. Change in Low-density lipoprotein (LDL) cholesterol

    Time frame: From week 40 to week 92

    Measured as ratio to baseline.

  17. Change in Very low-density lipoprotein (VLDL) cholesterol

    Time frame: From week 40 to week 92

    Measured as ratio to baseline.

  18. Change in non-HDL cholesterol

    Time frame: From week 40 to week 92

    Measured as ratio to baseline.

  19. Change in triglycerides

    Time frame: From week 40 to week 92

    Measured as ratio to baseline.

  20. Change in high-sensitivity C-reactive protein (hsCRP)

    Time frame: From week 40 to week 92

    Measured as ratio to baseline.

  21. Change in HbA1c

    Time frame: From week 0 to week 92

    Measured as % of HbA1c.

  22. Change in FPG

    Time frame: From week 0 to week 92

    Measured as mmol/L.

  23. Change in fasting insulin

    Time frame: From week 0 to week 92

    Measured as ratio to baseline.

  24. Change in DBP

    Time frame: From week 0 to week 92

    Measured as mmHg.

  25. Change in total cholesterol

    Time frame: From week 0 to week 92

    Measured as ratio to baseline.

  26. Change in HDL cholesterol

    Time frame: From week 0 to week 92

    Measured as ratio to baseline.

  27. Change in LDL cholesterol

    Time frame: From week 0 to week 92

    Measured as ratio to baseline.

  28. Change in VLDL cholesterol

    Time frame: From week 0 to week 92

    Measured as ratio to baseline.

  29. Change in non-HDL cholesterol

    Time frame: From week 0 to week 92

    Measured as ratio to baseline.

  30. Change in triglycerides

    Time frame: From week 0 to week 92

    Measured as ratio to baseline.

  31. Change in hsCRP

    Time frame: From week 0 to week 92

    Measured as % of hsCRP.

  32. Change in waist circumference

    Time frame: From week 0 to week 92

    Measured as cm.

  33. Change in SBP

    Time frame: From week 0 to week 92

    Measured as mmHg.

  34. Change in IWQOL-Lite-CT: physical composite score

    Time frame: From week 40 to week 92

    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.

  35. Change in IWQOL-Lite-CT: psychosocial composite score

    Time frame: From week 40 to week 92

    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.

  36. Change in IWQOL-Lite-CT: total score

    Time frame: From week 40 to week 92

    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.

  37. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From week 0 to week 40

    Measured as events.

  38. Number of Treatment Emergent Serious Adverse Events (TESAEs)

    Time frame: From week 0 to week 40

    Measured as events.

  39. Number of TEAEs leading to permanent treatment discontinuation

    Time frame: From week 0 to week 40

    Measured as events.

  40. Number of TEAEs

    Time frame: From week 40 to week 96

    Measured as events.

  41. Number of TESAEs

    Time frame: From week 40 to week 96

    Measured as events.

  42. Number of TEAEs leading to permanent treatment discontinuation

    Time frame: From week 40 to week 96

    Measured as events.

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

Efficacy and Safety of NNC0487-0111 s.c. Once Weekly in Participants With Obesity Who Have Reached Target Dose During run-in Period (AMAZE 12)

Acronym: AMAZE 12

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 31, 2026
Registry last updated
Jul 9, 2026

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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