Weekly NNC0487-0111 injections to help maintain weight loss
Efficacy and Safety of NNC0487-0111 s.c. Once Weekly in Participants With Obesity Who Have Reached Target Dose During run-in Period (AMAZE 12)
This trial tests whether weekly injections of NNC0487-0111 help adults with excess body weight keep weight off compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 72 sites (Anniston, Alabama and 71 other locations) |
| Trial ID | NCT07503210 on ClinicalTrials.gov |
What this trial studies
AMAZE 12 is a phase 3, randomized study comparing weekly subcutaneous NNC0487-0111 injections to a matching placebo in adults with excess body weight. Participants are assigned by chance to one of two arms and receive injections once a week with regular clinic visits for monitoring. Key exclusions include diagnosed diabetes, an HbA1c ≥6.5% at screening, and prior use of GLP-1–based treatments, dual GLP-1/GIP agents, or amylin analogues. The trial is sponsored by Novo Nordisk A/S and is conducted at several U.S. research centers with on-site dosing and safety assessments.
Who should consider this trial
Good fit: Adults aged 18 or older with excess body weight who do not have diagnosed diabetes, have an HbA1c below 6.5%, and have not recently used GLP-1–based therapies or amylin analogues are the intended candidates.
Not a fit: People with type 1 or type 2 diabetes, an HbA1c ≥6.5%, or prior treatment with GLP-1/GIP or amylin medications before screening are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, NNC0487-0111 could help adults maintain weight loss and reduce the likelihood of weight regain.
How similar studies have performed: Other GLP-1 and dual GIP/GLP-1 therapies have shown substantial weight loss and maintenance in recent trials, so this approach builds on established, successful mechanisms even though NNC0487-0111 itself is novel.
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 the informed consent. Exclusion Criteria: * Glycated haemoglobin (HbA1c) greater than or equal to ≥ 6.5% \[48 millimoles per mole (mmol/mol)\] 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
Anniston, Alabama and 71 other locations
- Pinnacle Research Group LLC — Anniston, Alabama, United States (Recruiting)
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States (Recruiting)
- Florida Inst For Clin Res LLC — Orlando, Florida, United States (Recruiting)
- Endeavor Health — Skokie, Illinois, United States (Not_yet_recruiting)
- Midwest Inst For Clin Res — Indianapolis, Indiana, United States (Recruiting)
- Medication Mgmnt, LLC_Grnsboro — Greensboro, North Carolina, United States (Recruiting)
- PMG Research of Wilmington 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)
- North Texas Endocrine Center — Dallas, Texas, United States (Not_yet_recruiting)
- UT Southwestern Med Cntr — Dallas, Texas, United States (Recruiting)
- Selma Medical Associates — Winchester, Virginia, United States (Recruiting)
- Rainier Clin Res Ctr Inc — Renton, Washington, United States (Recruiting)
- Conexa — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina (Recruiting)
- CICEMO- Consultorio (Av Directorio) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (Recruiting)
- Instituto de Investigaciones Clinicas Mar Del Plata — Mar del Plata, Buenos Aires, Argentina (Recruiting)
- CIPREC Pueyrredon — Buenos Aires, 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 (Not_yet_recruiting)
- Nightingale Research — Adelaide, South Australia, Australia (Not_yet_recruiting)
- Anima Research Center — Diepenbeek, Belgium (Not_yet_recruiting)
- AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie — Kortrijk, Belgium (Not_yet_recruiting)
- Centre hospitalier universitaire de Liège (CHU de Liège) — Liège, Belgium (Not_yet_recruiting)
- AZ OOSTENDE (Campus DAMIAAN) — Ostend, Belgium (Not_yet_recruiting)
- DCC 1 - Lom EOOD — Lom, Bulgaria (Not_yet_recruiting)
- MHAT Med Line Clinic — Plovdiv, Bulgaria (Not_yet_recruiting)
- UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic — Plovdiv, Bulgaria (Not_yet_recruiting)
- AIPSOMCEMD ENDO MED CONSULT 2020 - Dr. Aleksander Botushanov EOOD — Plovdiv, Bulgaria (Not_yet_recruiting)
- SGHAT Dr. Shterev EOOD — Sofia, Bulgaria (Not_yet_recruiting)
- UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases — Sofia, Bulgaria (Not_yet_recruiting)
- Medical Center Maraya Med EOOD — Sofia, Bulgaria (Not_yet_recruiting)
- AIPSMC Dr. Traykovska EOOD — Sofia, Bulgaria (Not_yet_recruiting)
- Sjællands Universitetshospital, Køge - Medicinsk Afdeling — Køge, Region Sjælland, Denmark (Not_yet_recruiting)
- Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden — Esbjerg, Region Syddanmark, Denmark (Not_yet_recruiting)
- Sanos Clinic - Vejle — Vejle, Region Syddanmark, Denmark (Not_yet_recruiting)
- CHU DE CLERMONT-FERRAND-HOPITAL GABRIEL MONTPIED_Service de Nutrition — Clermont-Ferrand, France (Not_yet_recruiting)
- CHU GRENOBLE ALPES-SITE NORD MICHALLON_Endocrinologie,diabétologie,maladies de la nutrition — La Tronche, France (Not_yet_recruiting)
- GROUPE SOS SANTE-HOPITAL LE CREUSOT-HOTEL DIEU_ Service de Diabétologie — Le Creusot, France (Recruiting)
- CHU LILLE-HOPITAL CLAUDE HURIEZ_Service de Chirurgie Générale et Endocrinienne — Lille, France (Recruiting)
- CHU DE POITIERS_Centre d'investigation Clinique — Poitiers, France (Not_yet_recruiting)
- Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet — Speyer, LÄK Rheinland-Pfalz, Germany (Not_yet_recruiting)
- Wendisch - Dahl Hamburg - DZHW — Hamburg, Germany (Not_yet_recruiting)
- Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH — Leipzig, Germany (Not_yet_recruiting)
- Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz — Lingen, Germany (Not_yet_recruiting)
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose — Münster, Germany (Not_yet_recruiting)
- RED-Institut für medizinische Forschung und Fortbildung GmbH — Oldenburg in Holstein, Germany (Not_yet_recruiting)
- Zentrum für klinische Studien Alexander Segner — Saint Ingbert-Oberwürzbach, Germany (Not_yet_recruiting)
- Arcispedale Sant'Anna (Cona) - UO di Endocrinologia — Ferrara, Emilia-Romagna, Italy (Not_yet_recruiting)
- IRCCS Ospedale Policlinico San Martino - Medicina Interna e Specialità Mediche — Genoa, Liguria, Italy (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.