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NCT Number: NCT07400107

AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

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 and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases 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

Centro de Investigaciones Metabólicas, Capital Federal, 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.

Key Inclusion Criteria:

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
  • Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at screening.
  • Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening.

Key Exclusion Criteria:

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 milliliter (mL)/ minute (min)/1.73 meter squared (m^2) (2021 Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula), at screening.
  • Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
  • 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 using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

semaglutide

Drug

Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Placebo (matched to NNC0487-0111)

Drug

Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Placebo (matched to semaglutide)

Drug

Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Primary outcomes

  1. Relative change in body weight

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

    Measured as percentage of body weight.

Secondary outcomes

  1. Change in waist circumference

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

    Measured as centimeter (cm).

  2. Change in systolic blood pressure (SBP)

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

    Measured as millimeter of mercury (mmHg).

  3. Change in body weight

    Time frame: From baseline (week 0) to week 84 and week 104

    Measured as kilograms (kg).

  4. Change in body mass index (BMI)

    Time frame: From baseline (week 0) to week 84 and week 104

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

  5. Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)

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

    Measured as count of participants.

  6. Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)

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

    Measured as count of participants.

  7. Number of participants with achievement of HbA1c < 5.7% (yes/no)

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

    Measured as count of participants.

  8. Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)

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

    Measured as mmol/L.

  9. Change in FPG measured as milligrams per deciliter (mg/dL)

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

    Measured as mg/dL.

  10. Ratio to baseline: change in fasting insulin

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

    Measured as ratio.

  11. Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR)

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

    Measured as ratio.

  12. Change in diastolic blood pressure (DBP)

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

    Measured as mmHg.

  13. Ratio to baseline: change in total cholesterol

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

    Measured as ratio.

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

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

    Measured as ratio.

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

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

    Measured as ratio.

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

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

    Measured as ratio.

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

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

    Measured as ratio.

  18. Ratio to baseline: change in triglycerides

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

    Measured as ratio.

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

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

    Measured as ratio.

  20. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) to week 84 and week 109

    Measured as events.

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

    Time frame: From baseline (week 0) to week 84 and week 109

    Measured as events.

  22. Number of TEAEs leading to permanent treatment discontinuation

    Time frame: From baseline (week 0) to week 84 and week 109

    Measured as events.

  23. Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 millimole per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by a blood glucose (BG) meter)

    Time frame: From baseline (week 0) to week 84 and week 109

    Measured as episodes.

  24. Number of treatment-emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Time frame: From baseline (week 0) to week 84 and week 109

    Measured as episodes.

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 Compared to Semaglutide s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 8)

Acronym: AMAZE 8

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 10, 2026
Registry last updated
Mar 12, 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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