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Trial · Interventional

Not yet recruitingPhase 3Registry data

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

Short name AMAZE 8

NCTNCT07400107 (opens ClinicalTrials.gov in a new tab)Other idNN9490-8028Other idU1111-1313-8017Other id2024-520446-31
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 3
Enrollment
1,000 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
14 countries

United States, Argentina, Brazil, Bulgaria, Croatia, Germany, Hungary, India, Mexico, Poland, Portugal, Romania, Thailand, Turkey (Türkiye)

Start
20 May 2026 (estimated)
Primary completion
12 Dec 2028 (estimated)
Completion
26 Jan 2029 (estimated)
First posted
10 Feb 2026
Last update posted
12 Mar 2026
Conditions
Obesity · Overweight · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 not yet recruiting

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

    AMAZE 8

    NCT07400107

    est. 20 May 2026 to est. 26 Jan 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 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.

Interventions

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

Arms2

  • Experimental

    NNC0487-0111

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

  • Active comparator

    Semaglutide

    Participants will receive semaglutide and 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

    Registry description

    Measured as centimeter (cm).

  2. Change in systolic blood pressure (SBP)

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

    Registry description

    Measured as millimeter of mercury (mmHg).

  3. Change in body weight

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

    Registry description

    Measured as kilograms (kg).

  4. Change in body mass index (BMI)

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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Measured as mmol/L.

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

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

    Registry description

    Measured as mg/dL.

  10. Ratio to baseline: change in fasting insulin

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

    Registry description

    Measured as ratio.

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

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

    Registry description

    Measured as ratio.

  12. Change in diastolic blood pressure (DBP)

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

    Registry description

    Measured as mmHg.

  13. Ratio to baseline: change in total cholesterol

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

    Registry description

    Measured as ratio.

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

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

    Registry description

    Measured as ratio.

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

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

    Registry description

    Measured as ratio.

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

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

    Registry description

    Measured as ratio.

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

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

    Registry description

    Measured as ratio.

  18. Ratio to baseline: change in triglycerides

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

    Registry description

    Measured as ratio.

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

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

    Registry description

    Measured as ratio.

  20. Number of Treatment Emergent Adverse Events (TEAEs)

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

    Registry description

    Measured as events.

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). * 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.

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