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NNC0487-0111 for weight loss in adults with type 2 diabetes

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 2)

PHASE3 · Novo Nordisk A/S · NCT07533175

This trial will try once-weekly injections of NNC0487-0111 versus a matched placebo to see if adults with excess body weight and type 2 diabetes can lose more weight and tolerate the medicine.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment630 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S (industry)
Locations73 sites (Birmingham, Alabama and 72 other locations)
Trial IDNCT07533175 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, placebo-controlled study tests once-weekly subcutaneous injections of NNC0487-0111 compared with a matched placebo in adults with excess body weight and type 2 diabetes. Eligible participants are adults (≥18 years) with type 2 diabetes diagnosed at least 180 days earlier, HbA1c 7–10%, and managed with lifestyle measures and/or up to three oral antidiabetic drugs on a stable regimen. Participants are randomly assigned to receive NNC0487-0111 or placebo and will be followed for weight change, glycemic measures, and safety outcomes. The study is sponsored by Novo Nordisk and is being conducted at multiple U.S. research centers.

Who should consider this trial

Good fit: Adults aged 18 or older with type 2 diabetes for at least 180 days, excess body weight or obesity, HbA1c between 7% and 10%, and on a stable regimen of lifestyle measures or up to three oral diabetes medications are the intended participants.

Not a fit: People with severe kidney impairment (eGFR <30 mL/min/1.73 m^2), those with HbA1c outside the 7–10% range, recently diagnosed diabetes, or requiring diabetes treatments not allowed by the protocol are unlikely to be eligible or to receive benefit from this study.

Why it matters

Potential benefit: If successful, NNC0487-0111 could help people with type 2 diabetes and excess weight lose clinically meaningful weight and potentially improve blood sugar control.

How similar studies have performed: Other once-weekly injectable agents for weight loss and diabetes (for example GLP-1 receptor agonists and related compounds) have produced substantial weight loss and improved glycemic control in prior trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 more than equal to (≥) 180 days before 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.
* Haemoglobin A1c (HbA1c) 7-10% \[53-86 (millimoles per mole) mmol/mol\] (both inclusive) as measured by the central laboratory at screening.

Exclusion Criteria:

* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter per minute per meter square (mL/min/1.73 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) before screening or are expected to require treatment 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 randomisation. 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 trial is running

Birmingham, Alabama and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetes Mellitus, Overweight, Obesity

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.