AMAZE 1: NNC0487-0111 for adults with excess body weight
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (AMAZE 1)
This trial tests whether weekly injections of NNC0487-0111 help adults with excess body weight lose weight compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 72 sites (Miramar, Florida and 71 other locations) |
| Trial ID | NCT07339423 on ClinicalTrials.gov |
What this trial studies
AMAZE 1 is a phase 3, randomized, placebo-controlled trial in which participants receive once-weekly subcutaneous injections of either NNC0487-0111 or a matched placebo. Treatment assignment is by chance and the placebo is matched to the active injection. Key eligibility excludes people with diagnosed diabetes or an HbA1c of 6.5% or higher and those with prior treatment with GLP‑1–based or amylin drugs. The study is sponsored by Novo Nordisk and is being conducted at several clinic sites in Florida and Georgia.
Who should consider this trial
Good fit: Adults with excess body weight who have a history of at least one unsuccessful diet-based weight-loss attempt, have HbA1c below 6.5%, do not have diabetes, and have not been treated with GLP‑1–based or amylin therapies are the intended participants.
Not a fit: People with diagnosed type 1 or type 2 diabetes, an HbA1c of 6.5% or higher, or recent use of GLP‑1/gastric inhibitory peptide receptor agonists or amylin analogues are excluded and unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, NNC0487-0111 could help people with excess body weight lose clinically meaningful weight and reduce obesity-related health risks.
How similar studies have performed: Other injectable GLP‑1–based and dual incretin therapies have shown substantial weight loss in late‑phase trials, though NNC0487-0111 itself is a distinct investigational agent.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Male or female (sex at birth). * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * History of at least one self-reported unsuccessful dietary effort to lose body weight. Key Exclusion Criteria: * HbA1c ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records. * 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
Miramar, Florida and 71 other locations
- South Broward Research LLC — Miramar, Florida, United States (Recruiting)
- Clinical Neuroscience Solution — Orlando, Florida, United States (Recruiting)
- Hope Clin Res & Wellness — Conyers, Georgia, United States (Recruiting)
- Endeavor Health — Skokie, Illinois, United States (Recruiting)
- Midwest Inst For Clin Res — Indianapolis, Indiana, United States (Recruiting)
- StudyMetrix Research LLC — City of Saint Peters, Missouri, United States (Recruiting)
- New York Gastroenterology Associates — New York, New York, United States (Recruiting)
- UNC Eastowne Medical Office — Chapel Hill, North Carolina, United States (Recruiting)
- PharmQuest Life Sciences LLC — Greensboro, North Carolina, United States (Recruiting)
- Accellacare and KDCILM, LLC — Wilmington, North Carolina, United States (Recruiting)
- UPA Ctr Weight and Eating Dis — Philadelphia, Pennsylvania, United States (Recruiting)
- Clinical Res Collaborative — Cumberland, Rhode Island, United States (Recruiting)
- Medical Uni of SC Charleston — Charleston, South Carolina, United States (Recruiting)
- Coastal Carolina Research Ctr — North Charleston, South Carolina, United States (Recruiting)
- Hillcrest Clinical Research — Simpsonville, South Carolina, United States (Recruiting)
- Amarillo Medical Specialists — Amarillo, Texas, United States (Recruiting)
- Velocity Clinical Res-Dallas — Dallas, Texas, United States (Recruiting)
- Care United Research, LLC — Forney, Texas, United States (Recruiting)
- Washington Cntr Weight Mgmt — Arlington, Virginia, United States (Recruiting)
- Health Res of Hampton Roads — Newport News, Virginia, United States (Recruiting)
- Selma Medical Associates — Winchester, Virginia, United States (Recruiting)
- Rainier Clin Res Ctr Inc — Renton, Washington, United States (Recruiting)
- Fundación CESIM — Santa Rosa, La Pampa Province, Argentina (Recruiting)
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli — Buenos Aires, Argentina (Recruiting)
- Instituto de Investigaciones Clínicas Córdoba — Córdoba, Argentina (Not_yet_recruiting)
- Sanatorio Esperanza — Esperanza, Santa Fe, Argentina (Recruiting)
- Cipadi — Godoy Cruz, Argentina (Not_yet_recruiting)
- Instituto de Investigaciones Clinicas San Nicolás — San Nicolás, Argentina (Recruiting)
- Sydney Clinical Trials — Campbelltown, New South Wales, Australia (Recruiting)
- Sydney Cardiometabolic Centre — Liverpool, New South Wales, Australia (Recruiting)
- Hunter Diabetes Centre — Merewether, New South Wales, Australia (Recruiting)
- Heart of Australia — Chelmer, Queensland, Australia (Recruiting)
- HUB - Hôpital Erasme — Brussels, Belgium (Not_yet_recruiting)
- UZA - UZ Antwerpen - Department of Endocrinology — Edegem, Belgium (Not_yet_recruiting)
- UZ Gent - Endocrinologie - Diabetologie — Ghent, Belgium (Recruiting)
- UZ Leuven - Endocrinology — Leuven, Belgium (Recruiting)
- Meclinas — Mechelen, Belgium (Recruiting)
- AZ Delta - Roeselare — Roeselare, Belgium (Recruiting)
- C-Health Partners — Calgary, Alberta, Canada (Not_yet_recruiting)
- Ocean West Research Clinic — Surrey, British Columbia, Canada (Recruiting)
- G.A. Research Associates Ltd. — Moncton, New Brunswick, Canada (Recruiting)
- Nova Scotia Hlth Halifax — Halifax, Nova Scotia, Canada (Recruiting)
- Milestone Research — London, Ontario, Canada (Recruiting)
- Sanos Clinic - Vejle — Vejle, Region Syddanmark, Denmark (Recruiting)
- Sanos Clinic - Gandrup — Gandrup, Denmark (Recruiting)
- Steno Diabetes Center Nordjylland — Gistrup, Denmark (Completed)
- Gentofte Hospital - Center for Klinisk Metabolisk Forskning — Hellerup, Denmark (Not_yet_recruiting)
- Hillerød Endokrinologisk amb. H0652 — Hillerød, Denmark (Not_yet_recruiting)
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159 — Hvidovre, Denmark (Not_yet_recruiting)
- HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie — Paris, France (Not_yet_recruiting)
+22 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.