NCT07533175 AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
| NCT ID | NCT07533175 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novo Nordisk A/S |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 630 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2028-08-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 630 participants in total. It began in 2026-04-13 with a primary completion date of 2028-08-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. 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 (treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Eligibility 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.
Contact & Investigator
Clinical Transparency (dept. 2834)
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT07533175 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07533175 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 630 participants.
Is NCT07533175 currently recruiting?
Yes, NCT07533175 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT07533175 trial being conducted?
This trial is being conducted at Birmingham, United States, Escondido, United States, Lomita, United States, Walnut Creek, United States and 11 additional locations.
Who is sponsoring the NCT07533175 clinical trial?
NCT07533175 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency (dept. 2834) at Novo Nordisk A/S. The trial plans to enroll 630 participants.
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