Not yet recruiting · NCT07400107

A study testing whether a GLP-1 medicine from Novo Nordisk, semaglutide, can help with weight.

Who can join
Adults 18+, have obesity.
What you take
semaglutide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
How long it lasts
The full study runs about 2.7 years; your own time in it is usually shorter.
What you get
The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
Phase Phase 3Sponsor Novo Nordisk A/SDrug semaglutideClass GLP-1 RASites 10 USEnrollment target 1,000

What this study is for

Full study title: AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and .

Primary condition: Obesity. Also studied in: Overweight, Diabetes Mellitus, Type 2.

Who can join, in detail

Age 18 and up
Sex All

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.

Where this study is enrolling

This trial has 10 US sites across 7 states. Contact the site coordinator directly to start the screening process.

Florida

  • Encore Medical Research LLC
    Hollywood, Florida
  • Optimal Research Sites
    Orange City, Florida
  • Encore Medical Research of Weston
    Weston, Florida

Georgia

  • Endocrine Research Solutions, Inc
    Roswell, Georgia

Idaho

  • Elite Clinical Trials
    Blackfoot, Idaho

Maryland

  • Endo And Metab Cons
    Rockville, Maryland

Michigan

  • Arcturus Healthcare, PLC.
    Troy, Michigan

Texas

  • Velocity Clin Res, Dallas
    Dallas, Texas
  • Consano Clinical Research, LLC
    Shavano Park, Texas

Virginia

  • Selma Medical Associates
    Winchester, Virginia

Timeline

Started enrolling: 2026-05-20. Expected completion: 2029-01-26. Last updated on ClinicalTrials.gov: 2026-03-12.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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